18 1 月, 2023

Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023

TOKYO, Jan 18, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of research across various types of gastrointestinal cancers during the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI23), which is taking place in-person in San Francisco, California and virtually from January 19-21.Notable data include an update from the dose-escalation part of a Phase 1 Study evaluating E7386(1), a CREB-binding protein (CBP) / beta-catenin interaction inhibitor, in patients with advanced solid tumors including colorectal cancer (NCT03833700; Abstract: #106). Based on these additional analyses, further investigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing using two dose levels in the expansion part.Research from the LEAP (LEnvatinib And Pembrolizumab) clinical program includes a poster presentation featuring a health-related quality of life analysis from the Phase 3 LEAP-002 trial investigating the lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA(2)) combination versus lenvatinib plus placebo as a first- line treatment for patients with unresectable hepatocellular carcinoma (NCT03713593; Abstract: #506). Additional presentations on Eisai's oncology pipeline showcase Eisai's investigational compound, E7389- LF, a new liposomal formulation of eribulin, in combination with nivolumab in patients with solid tumors. Efficacy and safety were evaluated in expansion cohorts, including an esophageal cancer cohort (NCT04078295; Abstract: #337) and a gastric cancer cohort (NCT04078295; Abstract: #339)."We are eager to share new data at the annual symposium where specialists in gastrointestinal cancers gather from all over the world, including findings from a Phase 1 study evaluating the novel investigational anticancer agent, E7386, in advanced solid tumors including colorectal cancer," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "Our findings across colorectal, esophageal, gastric and liver cancer illustrate Eisai's commitment to further oncology research for people living with gastrointestinal cancers, who account for over one quarter of the global cancer incidence(1)."In March 2018, Eisai and Merck (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with Merck's anti-PD-1 therapy pembrolizumab. To date, more than 10 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.(1) E7386 is created through collaboration research between Eisai and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa)(2) KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, N.J., U.S.A.For more information, visit www.eisai.com/news/2023/pdf/enews202308pdf.pdf.Media Inquiries:Public Relations Department, Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

9 1 月, 2023

FDA Approves LEQEMBI (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer’s Disease

TOKYO and CAMBRIDGE, Mass., Jan 9, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that under the Accelerated Approval Pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb (Brand Name in the U.S.: LEQEMBI) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ("protofibril")* and insoluble forms of amyloid beta (Abata) for the treatment of Alzheimer's disease (AD). The approval is based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD. Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.INDICATIONLEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.DOSAGE AND ADMINISTRATION (Patient Selection, Dosing Instructions, Monitoring and Dosing Interruption for ARIA)The recommended dosage of LEQEMBI is 10 mg/kg administered intravenously once every two weeks to eligible patients with confirmed presence of Aβ pathology prior to initiating treatment. Enhanced clinical vigilance for amyloid-related imaging abnormalities (ARIA) is recommended during the first 14 weeks of treatment with LEQEMBI. Baseline, recent (within one year) brain MRI prior to initiating treatment with LEQEMBI and periodic monitoring with MRI prior to the 5th, 7th, and 14th infusions should be obtained.ADVERSE REACTIONSThe safety of LEQEMBI has been evaluated in 763 patients who received at least one dose of LEQEMBI in Study 201. The most common adverse reactions reported in at least 5% of patients treated with LEQEMBI 10 mg/kg biweekly (N=161) and at least 2% higher incidence than patients on placebo (N=245) were infusion-related reactions (LEQEMBI 20%; placebo 3%), headache (LEQEMBI 14%; placebo 10%), ARIA-E (LEQEMBI 10%; placebo 1%), cough (LEQEMBI, 9%; placebo, 5%) and diarrhea (LEQEMBI, 8%; placebo, 5%). The most common adverse reaction leading to discontinuation of LEQEMBI was infusion- related reactions that led to discontinuation in 2% (4/161) of patients treated with LEQEMBI compared to 1% (2/245) of patients on placebo.CONCOMITANT ANTITHROMBOTIC MEDICATION AND OTHER RISK FACTORS FOR INTRACEREBRAL HEMORRHAGE Patients were excluded from enrollment in Study 201 for baseline use of anticoagulant medications. Antiplatelet medications such as aspirin and clopidogrel were allowed. Patients who received LEQEMBI and an antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) did not have an increased risk of ARIA-H compared to patients who received placebo and an antithrombotic medication. The majority of exposures to antithrombotic medications were to aspirin; few patients were exposed to other antiplatelet drugs or anticoagulants, limiting any meaningful conclusions about the risk of ARIA or intracerebral hemorrhage in patients taking other antiplatelet drugs or anticoagulants. Because intracerebral hemorrhages greater than 1 cm in diameter have been observed in patients taking LEQEMBI, additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Additionally, patients were excluded from enrollment in Study 201 for the following risk factors for intracerebral hemorrhage: prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, evidence of vasogenic edema, evidence of cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts or stroke involving a major vascular territory, and severe small vessel or white matter disease. Caution should be exercised when considering the use of LEQEMBI in patients with these risk factors."The FDA's approval of LEQEMBI under the Accelerated Approval pathway is an important milestone in Eisai's four decades of research in Alzheimer's disease and reflects our continued commitment to alleviating the burden of Alzheimer's disease for patients and their families. Eisai has made great efforts to understand the reality of the challenges and concerns facing patients and their families who are living in the various stages of Alzheimer's disease, and we are incredibly pleased to offer LEQEMBI as a new treatment option to help with the tremendous unmet needs of this community," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. -The challenges of Alzheimer's disease reach beyond medical implications for patients and considerations for their families, but also impact society as a whole through reduced productivity, elevated social costs and anxiety. Upon receiving this Accelerated Approval, we will focus on providing important information on proper usage of LEQEMBI to healthcare professionals. Eisai will also engage with various payers to provide access to LEQEMBI, offer a patient support program, and will do its utmost to complete submission for traditional approval as soon as possible to serve more people living with early Alzheimer's disease.""The approval of LEQEMBI provides new hope to patients with Alzheimer's disease. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors. Our focus now is on the path forward, working alongside Eisai with the goal of making LEQEMBI available to patients who may benefit from this treatment as soon as possible," said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. "This approval is also a recognition of the many scientists and doctors who have, over many years, patiently and persistently worked to find a treatment for this highly complex disease. Eisai and Biogen have collaborated for nearly a decade to advance research to improve the lives of those suffering from Alzheimer's, and we know that this commitment must and will continue in the fight against Alzheimer's disease."LEQEMBI's ACCESS AND INITIATIVES TO SUPPORT PEOPLE LIVING WITH ADThe Eisai Patient Support Program offers several support programs to help patients and care partners. Dedicated Patient Navigators will work directly with patients and families to navigate treatment and coverage for eligible and appropriate patients and to help with what to expect regarding insurance coverage, co-pay and patient access programs. To learn more visit LEQEMBI.com, call 1-833-4-LEQEMBI (1-833- 453-7362), Monday-Friday, 8 a.m. to 8 p.m. Eastern Time or fax to 1-833-770-7017.In addition, to support access to LEQEMBI for certain financially disadvantaged patients, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI at no cost, for eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other program criteria.Eisai looks forward to continuing to engage constructively with various payors, including the Centers for Medicare and Medicaid (CMS), TRICARE, the U.S. Veteran's Health Administration and private health insurance companies to ensure appropriate beneficiaries have access to this new therapy. Currently, Medicare patients do not have access to LEQEMBI. Medicaid sole beneficiaries who are diagnosed by a healthcare professional with mild cognitive impairment or mild dementia stage of disease, and with confirmed presence of amyloid plaque in the brain will have access to LEQEMBI under the Medicaid program post accelerated approval, depending on individual state processes.Eisai is developing a multi-faceted educational initiative to further advance the understanding in the AD healthcare community of the real-world management and monitoring of ARIA. This initiative, Understanding ARIA, will provide resources and programs that will include peer-to-peer education, individual and group educational sessions and subject-matter-expert evaluation of historical case studies. Understanding ARIA will include engagements with leading experts in medical imaging as well as major professional societies. Initial resources will be available by January 2023. LEQEMBI will be available during or before the week of January 23, 2023. Eisai announced the U.S. pricing and rationale for LEQEMBI today.Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.*Protofibrils are large Aβ aggregated soluble species of 75-500 Kd. 1, 2INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.INDICATIONLEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONSAmyloid Related Imaging Abnormalities- LEQEMBI can cause amyloid related imaging abnormalities-edema (ARIA-E) and -hemosiderin deposition (ARIA-H). ARIA-E can be observed on MRI as brain edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. ARIA is usually asymptomatic, although serious and life- threatening events, including seizure and status epilepticus, rarely can occur. Reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms associated with ARIA usually resolve over time.ARIA Monitoring and Dose Management Guidelines- Obtain recent (within one year) brain magnetic resonance imaging (MRI) prior to initiating treatment with LEQEMBI. Obtain an MRI prior to the 5th, 7th, and 14th infusions.- Recommendations for dosing in patients with ARIA-E and ARIA-H depend on clinical symptoms and radiographic severity. Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.- Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.- There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E. There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E. There are limited data in dosing patients who experienced recurrent ARIA-E.Incidence of ARIA- In Study 1 (Study 201), symptomatic ARIA occurred in 3% (5/161) of LEQEMBI-treated patients. Clinical symptoms associated with ARIA resolved in 80% of patients during the period of observation.- Including asymptomatic cases, ARIA was observed in LEQEMBI: 12% (20/161); placebo: 5% (13/245). ARIA-E was observed in LEQEMBI: 10% (16/161); placebo: 1% (2/245). ARIA-H was observed in LEQEMBI: 6% (10/161); placebo: 5% (12/245). There was no increase in isolated ARIA-H for LEQEMBI compared to placebo.- Intracerebral hemorrhage >1 cm in diameter was reported after one treatment in LEQEMBI: 1 patient; placebo: zero patients. Events of intracerebral hemorrhage, including fatal events, in patients taking LEQEMBI have also been reported in other studies. Apolipoprotein E ε4 (ApoE ε4) Carrier Status and Risk of ARIA- In Study 1, 6% (10/161) of patients in the LEQEMBI group were ApoE ε4 homozygotes, 24% (39/161) were heterozygotes, and 70% (112/161) were noncarriers.- The incidence of ARIA was higher in ApoE ε4 homozygotes than in heterozygotes and noncarriers among patients treated with LEQEMBI. Of the 5 LEQEMBI-treated patients who had symptomatic ARIA, 4 were ApoE ε4 homozygotes, 2 of whom experienced severe symptoms. An increased incidence of symptomatic and overall ARIA in ApoE ε4 homozygotes compared to heterozygotes and noncarriers in LEQEMBI-treated patients has been reported in other studies.- The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.- Consider testing for ApoE ε4 status to inform the risk of developing ARIA when deciding to initiate treatment with LEQEMBI.Radiographic Findings- The majority of ARIA-E radiographic events occurred early in treatment (within the first 7 doses), although ARIA can occur at any time and patients can have more than 1 episode. The maximum radiographic severity of ARIA-E in patients treated with LEQEMBI was mild in 4% (7/161) of patients, moderate in 4% (7/161) of patients, and severe in 1% (2/161) of patients. Resolution on MRI occurred in 62% of ARIA-E patients by 12 weeks, 81% by 21 weeks, and 94% overall after detection. The maximum radiographic severity of ARIA-H microhemorrhage in patients treated with LEQEMBI was mild in 4% (7/161) of patients and severe in 1% (2/161) of patients; 1 of the 10 patients with ARIA-H had mild superficial siderosis.Concomitant Antithrombotic Medication and Other Risk Factors for Intracerebral Hemorrhage- Patients were excluded from enrollment in Study 1 for baseline use of anticoagulant medications. Antiplatelet medications such as aspirin and clopidogrel were allowed. If anticoagulant medication was used because of intercurrent medical events that required treatment for ≤4 weeks, treatment with LEQEMBI was to be temporarily suspended.- Most exposures to antithrombotic medications were to aspirin; few patients were exposed to other antiplatelet drugs or anticoagulants, limiting any meaningful conclusions about the risk of ARIA or intracerebral hemorrhage in patients taking other antiplatelet drugs or anticoagulants. Because intracerebral hemorrhages >1 cm in diameter have been observed in patients taking LEQEMBI, additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI.- Patients were excluded from enrollment in Study 1 for the following risk factors for intracerebral hemorrhage: prior cerebral hemorrhage >1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, evidence of vasogenic edema, evidence of cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts or stroke involving a major vascular territory, and severe small vessel or white matter disease. Caution should be exercised when considering the use of LEQEMBI in patients with these risk factors.Infusion-Related Reactions- Infusion-related reactions were observed in LEQEMBI: 20% (32/161); placebo: 3% (8/245), and the majority of cases in LEQEMBI-treated patients (88%, 28/32) occurred with the first infusion. All infusion- related reactions were mild (56%) or moderate (44%) in severity. Infusion-related reactions resulted in discontinuations in 2% (4/161) of patients treated with LEQEMBI. Symptoms of infusion-related reactions included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.- After the first infusion, 38% of LEQEMBI-treated patients had transient decreased lymphocyte counts to <0.9 x109/L compared to 2% on placebo, and 22% of LEQEMBI-treated patients had transient increased neutrophil counts to >7.9 x109/L compared to 1% on placebo.- In the event of an infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered.ADVERSE REACTIONS- In Study 201, 15% of LEQEMBI-treated patients, compared to 6% of placebo-treated patients, stopped study treatment because of an adverse reaction. The most common adverse reaction leading to discontinuation of LEQEMBI was infusion-related reactions that led to discontinuation in 2% (4/161) of patients treated with LEQEMBI compared to 1% (2/245) of patients on placebo.- The most common adverse reactions reported in ≥5% of patients treated with LEQEMBI (N=161) and ≥2% higher than placebo (N=245) in Study 1 were infusion-related reactions (LEQEMBI: 20%; placebo: 3%), headache (LEQEMBI: 14%; placebo: 10%), ARIA-E (LEQEMBI: 10%; placebo: 1%), cough (LEQEMBI: 9%; placebo: 5%), and diarrhea (LEQEMBI: 8%; placebo: 5%).Please see full Prescribing Information (bit.ly/3itBERp).Media Contacts:Eisai Co., Ltd. Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+ 1-201-753-1945Libby_Holman@eisai.com Biogen Inc.Natacha Gassenbach+ 1-857-777-6573public.affairs@biogen.comEisai Europe, Ltd.(UK, Europe, Australia, New Zealand and Russia) EMEA Communications Department +44 (0) 786 601 1272EMEA-comms@eisai.netInvestor Contacts:Eisai Co., Ltd.Investor Relations Department TEL: +81 (0) 3-3817-5122 Biogen Inc.Mike Hencke+ 1-781-464-2442IR@biogen.comFor more information, visit www.eisai.com/news/2023/pdf/enews202301pdf.pdf Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

24 11 月, 2022

Eisai to Present Latest Data on Perampanel at the 76th American Epilepsy Society (AES) Annual Meeting

TOKYO, Nov 24, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the company will have a total of 34 poster presentations, including the latest data on its in-house discovered and developed anti-epileptic agent (AED) perampanel (product name: Fycompa) at the 76th American Epilepsy Society Annual Meeting (AES 2022), to be held in Nashville, Tennessee and virtually from December 2-6, 2022.Key data Presentations for perampanel include the:- Results from a post hoc analysis of the phase III clinical trial (FREEDOM/342), which evaluated long-term efficacy of perampanel monotherapy by seizure type in the open-label extension (52 weeks) for epilepsy patients with focal-onset seizures (FOS), ≥ 12 years of age without prior treatment history (poster number: 2.228)- Real-world pooled analyses of perampanel for pediatric patients (poster number: 1.310),adolescent patients (poster number: 1.313) and elderly patients (poster number: 1.312)- Results from a post hoc analysis of two phase III open-label extension (OLEx) studies, Study 307 and Study 335 OLEx, evaluating the long-term efficacy and safety of adjunctive perampanel in a subgroup of older adult patients aged ≥ 60 years (poster number: 1.291)"With 34 poster presentations planned for this year's AES Meeting, we look forward to furthering our understanding of the results that may impact overall care in epilepsy," said Ivan Cheung, Senior Vice President Global Alzheimer's Disease Officer President, Americas Region, Eisai Co., Ltd., "We remain focused on addressing the diverse needs of patients with epilepsy and their families."Perampanel is a first-in-class AED discovered by Eisai's Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper- excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. The agent is currently approved for partial-onset seizures (with or without secondarily generalized seizures) in over 70 countries including Japan, the United States, China and other countries in Europe and in Asia. The agent is currently approved as an adjunctive therapy for primary generalized tonic-clonic seizures in over 70 countries including Japan, the United States, and other countries in Europe and in Asia.Eisai considers neurology, including epilepsy, a therapeutic area of focus. Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy. Eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their familiesFor more information, visit www.eisai.com/news/2022/pdf/enews202281pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

2 11 月, 2022

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

TOKYO, Nov 2, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has received notification from Japan's Ministry of Health, Labour, and Welfare (MHLW) that the "all-case study" specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared. In March 2013, the MHLW approved Inovelon as an adjunctive therapy with other antiepileptic drugs for tonic and atonic seizures associated with LGS showing insufficient response to other antiepileptics, with the following condition: "Because of the very limited number of subjects included in the Japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients until data from a certain number of patients is accumulated after its launch in the market, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product." Based on the safety data in 702 patients and efficacy data in 495 patients submitted to the MHLW as the results of analyses of this all-case study, the MHLW has concluded that the all-case study was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition. Eisai will continually strive to promote the proper use of Inovelon and provide information about the product, thereby making further contributions to increase the benefits to patients and their families.For more information, visit www.eisai.com/news/2022/news202275.html.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

10 10 月, 2022

Hua Medicine’s Innovative First-In-Class Glucokinase Activator (GKA) HuaTangNing Is Approved, New Type 2 Diabetes Treatment Paradigm to Begin in China

SHANGHAI, CHINA, Oct 10, 2022 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", HKEx Stock Code: 2552.HK) today announces that the New Drug Application (NDA) of HuaTangNing (dorzagliatin tablets, HMS5552), a first-in-class glucokinase activator (GKA) developed by the Company has been approved by the National Medical Products Administration (NMPA) of China on October 8th for two indications, both to improve blood glucose control for Type 2 diabetes (T2D) patients, as monotherapy for drug-naive T2D patients, or in combination with metformin in metformin tolerated T2D patients to control blood glucose level. For those patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. At the same time, clinical trials have shown that HuaTangNing in combination with empagliflozin (SGLT-2 inhibitor) and sitagliptin (DPP-IV inhibitor) is expected to better improve blood glucose control and pancreatic islet functions in T2D patients than either empagliflozin or sitagliptin taken alone.HuaTangNing is the first approved glucokinase activator (GKA) worldwide. Accordingly, the commercialization of HuaTangNing represents the first time globally in almost ten years that a new mechanism of action to treat Type 2 diabetes is introduced, and the first time in history that a global first-in-class drug for Type 2 diabetes is introduced first in China. This milestone represents unprecedented progress in the application of innovative scientific concepts in the Chinese biopharmaceutical industry to meet the clinical needs of Chinese patients. HuaTangNing is the first innovative first-in-class drug developed using the operation model of "Integration of global pharmaceutical research and development resources, to achieve joint innovation," and whereby China has led pharmaceutical innovation into a new historical stage.With the mission of "For Patients, Global Innovation, Effective Medicines", Hua Medicine has independently developed HuaTangNing, a first-in-class drug based on the characteristics of Chinese diabetic patients. Since the beginning of its scientific development, the research and development project of HuaTangNing has been highly valued by the new drug R&D community and national drug regulators. The project was selected as a national key scientific and technological project during the "12th Five-Year Plan" and the "13th Five-Year Plan" periods. HuaTangNing is a drug with new concept, new mechanism, new efficacy, new structure and new technology. It is led by a Chinese R&D team and Chinese clinical researchers from pre-clinical to Phase I, II, and III clinical trials. Therefore, it is not only a major R&D breakthrough in translating innovative concepts into innovative products, but also a pioneering path for China in developing first-in-class drugs independently. The approval of HuaTangNing also represents the first approved GKA drug, after many large and small pharmaceutical companies globally have spent over 2 decades of R&D resources on the glucokinase activator class, thereby achieving a breakthrough from zero. Going forward, Hua Medicine will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families.Globally, the incidence of diabetes has been on the rise. According to the International Diabetes Federation (IDF), the number of adult diabetes patients worldwide reached 537 million in 2021, which was an increase of 74 million or 16% from 2019. Global health spending due to diabetes and its complications stood at USD 966 billion in 2021. China is no exception. There were over 140 million diabetic patients in 2021, 51.7% of which (around 72.83 million) have not been diagnosed or treated. In addition, fluctuating blood glucose levels lead to a series of diabetic complications such as cardiovascular and cerebrovascular, kidney, eye diseases, and diabetic feet, etc., which greatly affect the survival and life quality of diabetic patients, and exert a heavy pressure on their families. Therefore, stabilizing the T2D patient's blood glucose level at a good TIR (Time in Range) is an important goal in diabetes treatment and management. According to the 14th Five-Year National Health Planning issued by the General Office of the State Council, improving the prevention and treatment capacity of diabetes and other major chronic diseases is a key health-care topic for the country. It is estimated that over 65% of T2D patients will be covered by the health management service of community-level medical institutions during the 14th Five Year Plan period. The NDA approval and HuaTangNing adheres closely to the national strategy of developing the pharmaceutical industry and improving citizens' health.A rapidly growing population of diabetic patients and a huge market for diabetes drugs clearly establish strong unmet medical needs. With the original concept of "repairing the sensor, restoring homeostasis, and treating the underlying cause of diabetes", Hua Medicine boldly aims at directly addressing the root cause of the failure of blood glucose sensors in T2D patients. Clinical studies have shown that HuaTangNing can restore the impaired glucokinase sensor function and improve the ability of T2D patients to regulate blood glucose autonomously, thus potentially control the progression and complications of Type 2 diabetes from its source.As a new class of T2D treatment drug, the R&D of HuaTangNing has received continuous attention from the academic community worldwide. In 2018, the results of its Phase II clinical trial were published in The Lancet Diabetes and Endocrinology, a top international medical journal, which was the first time for the journal to publish the clinical research results of a T2D original innovative drug from China. In May 2022, Nature Medicine, a top international medical journal, simultaneously published two peer-reviewed papers on the results of our two Phase III clinical trials, describing the results of our monotherapy trial (the SEED study), and in combination with metformin trial (the DAWN study), respectively. It fully recognized HuaTangNing as a first-in-class diabetic drug with significant safety advantages and the characteristics of improving pancreatic islet functions in T2D patients. The unique advantages of HuaTangNing in T2D patients with nephropathy suggested by the clinical trials was also highlighted. Other clinical research also showed that HuaTangNing safely creates clear synergies in combination therapy with DPP-4 inhibitors and SGLT-2 inhibitors in blood glucose control, suggesting its broader potential in T2D patients with different needs in glycemic control and at different stages of disease progression. By potentially restoring early-phase insulin secretion and improving beta-cell function, HuaTangNing is expected to be a key path in diabetes remission. In the future, Hua Medicine will continue to explore HuaTangNing's potential in the remission of T2D drug discontinuation and the combination therapies with the other nine existing types of diabetes drugs. Hua Medicine is committed to addressing the needs of diabetic prevention, remission and complication control, and bringing Chinese innovation to the world.Xiaolan Zhou, Executive Vice President, Pharmaceuticals Division, Bayer AG and President of Bayer Pharmaceuticals China, said, "Bayer has been working on diabetes treatment and contributing to the development of diabetes prevention and treatment in China for years. HuaTangNing and Glucobay, the first oral hypoglycemic drug with impaired glucose tolerance (IGT), together with continuous glucose monitoring systems (CGMs), establish end-to-end course management from prevention to treatment for Chinese T2D patients. Real-time blood glucose monitoring helps achieve the goal of 'steady blood glucose control'. At the same time, Bayer proactively explores digital solutions to help hundreds of millions of Chinese patients to achieve the vision of diabetes-free."Dr. Li Chen, the founder, CEO and Chief Scientific Officer of Hua Medicine, said, "the NDA approval of HuaTangNing is a major milestone for Hua Medicine, as it also marks that the innovative drug industry in China has entered a new stage of new development. Diabetes chronic disease management is strategically important for China's economy and people's livelihood. Hua Medicine adheres to our original intention of 'China leading pharmaceutical innovation'. Amid fierce international competition, researchers and partners of Hua Medicine have spent 10 years of hard work to develop the first-in-class new diabetes drug - first in the world and start from China, achieving a breakthrough from zero. This achievement is attributed to all Chinese scientists, clinicians and partners participated in the R&D of HuaTangNing. We are proud of HuaTangNing and grateful to everyone for their hard work and wholehearted dedication. At the same time, Hua Medicine looks forward to in-depth integration and full vitality with Bayer in the commercialization of HuaTangNing, which will bring new hope of diabetes prevention, treatment and relief to up to one hundred million Chinese T2D patients, establish standards for diabetes prevention and treatment, and contribute to the national strategy of achieving Healthy China 2030."About HuaTangNingHuaTangNing (dorzagliatin tablets) is a first-in-class glucokinase allosteric activator (GKA) with a brand-new mechanism. It can be used alone or in combination with metformin hydrochloride (when using metformin hydrochloride alone is ineffective in controlling blood glucose), to improve blood glucose control for T2D adult patients with diet and exercise. HuaTangNing targets at restoring the impaired glucose sensor glucokinase (GK) in pancreas, intestine and liver, to achieve one target with multiple points and coordinated blood glucose control. It regulates glucose stimulated secretion of the glycemic controlling hormones insulin, GLP-1 and glucagon in diabetes patients, which leads to the improvement of early-phase insulin secretion and disposition index. It has potential in restoring glucose homeostasis and diabetes remission. Results from two Phase III registered trials of HuaTangNing monotherapy and combination therapy with metformin in metformin tolerated T2D patients have shown that HuaTangNing significantly improves glycemic control with effective reduction of post prandial glucose, low risk of hypoglycemia, well tolerance and safety. HuaTangNing demonstrated a linear correlation between drug dose and plasma exposure, with high target organs distributed in pancreas, intestine and liver. It showed low renal excretion and similar pharmacokinetic profiles at End Stage Renal Disease (ESRD) patients and healthy subjects, which suggest it can be readily used in those patients with renal insufficiency without dose adjustment. The unique mechanism of action, desirable pharmacokinetic, and good safety and tolerability profile establish HuaTangNing as a differentiated new class of anti-diabetes therapy.About Hua MedicineHua Medicine is an innovative drug development company found in China, focused on developing novel therapies for patients worldwide with unmet medical needs. Based on global resources, Hua Medicine teams up with global high-caliber people to develop breakthrough technologies and products, which contribute a global innovation in diabetes care. Targeting the glucose sensor, glucokinase, HuaTangNing (dorzagliatin tablets) as Hua Medicine's cornerstone product, restores glucose sensitivity in T2D patients and has completed registered SEED and DAWN Phase III trials in China. The NDA (New Drug Application) of HuaTangNing has been officially approved by the China National Medical Products Administration (NMPA). This first-in-class glucokinase activator has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.About BayerBayer is a global enterprise with core competencies in health and agriculture of life science. Its products and services are designed to help human and the earth thrive by supporting the efforts to overcome major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable growth and having a positive impact on business. At the same time, Bayer aims to increase its profitability and create value through innovation and growth. Globally, the brand of Bayer stands for trust, reliability and quality. In the fiscal year of 2020, Bayer had around 100,000 employees, 41.4 billion euros of sales, and 4.9 billion euros of R&D expenses (excluding special programs). For more information, please visit www.bayer.com.About the cooperation between Hua Medicine and BayerIn August 2020, Bayer, a multinational pharmaceutical company, and Hua Medicine, a Chinese innovative drug research and development company, announced a strategic partnership on dorzagliatin, a first-in-class diabetes treatment drug, in China. This partnership aims at leveraging Bayer's prominent advantages in diabetes management in China and Hua Medicine's R&D expertise in diabetes treatment. Both parties are committed to benefiting hundreds of millions of China diabetic patients through new therapeutic options. Under the terms of the agreement, Hua Medicine as the market authorization holder (MAH) shall be responsible for clinical development, registration, product supply and distribution, while Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China. The Pharmaceuticals China Innovation Center of Bayer facilitated this collaboration. As a global pharmaceutical leader, Bayer is committed to cooperating with external partners to promote breakthrough innovations, bring positive changes to patients, and achieve the goal of "cooperative innovation and joint cure". Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

28 9 月, 2022

Claudin18.2, a shining star in gastric cancer, Transcenta’s TST001 stands at the global forefront

HONG KONG, Sep 28, 2022 - (ACN Newswire via SEAPRWire.com) - Transcenta Holding Limited (06628.HK), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announced that interim safety and efficacy data of dose expansion cohort from the phase I/II study of TST001 (Osemitamab), a humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, in combination with Capecitabine and Oxaliplatin (CAPOX) as a first line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer was presented in a poster at the European Society for Medical Oncology (ESMO) Congress 2022. In first line treatment of advanced or metastatic G/GEJ cancer, early interim data of the first 15 patients with measurable disease receiving the combination of TST001 with CAPOX demonstrated a partial response rate of 73.3% and a disease control rate of 100% per RECIST1.1. Based on these encouraging data, the TST001 program is further accelerated and Health Authority consultations are being initiated. A global phase III clinical program of TST001 (Osemitamab) for the first line treatment of locally advanced or metastatic Claudin18.2 positive G/GEJ cancer is currently being planned. 1. Claudin18.2 is expected to be the most shining star target in gastric cancer The European Society for Medical Oncology (ESMO) Congress 2022 was held in person in Paris and virtually between 9-13 September 2022. Around 2000 abstracts and late-breaking abstracts were presented during the congress days. Transcenta's poster with the dose expansion cohort interim data from the TST001 in combination with chemotherapy in first line treatment of locally advanced or metastatic G/GEJ cancer patients with Claudin18.2 expression was presented on Sept 12, 2022.Data shows that as of August 4, 2022, 51 patients were enrolled and dosed including 36 patients treated with TST001 plus CAPOX at 6mg/kg Q3W in the expansion phase. Among the 15 patients with measurable disease and at least one post-treatment tumor assessment, 11 (73.3%) achieved partial response and four (26.7%) achieved stable disease. All 51 enrolled patients were evaluated for safety and tolerability. Treatment-emergent adverse events regardless of causality were mostly grade 1-2. Twelve (23.5%) patients experienced dose delay, five (9.8%) experienced dose reduction and no patient experienced discontinuation due to treatment related adverse events. In this study, TST001 also demonstrated a clear dose proportional pharmacokinetic profile, is consistent with those observed with TST001 monotherapy and in US patients. These data suggest that TST001 combined CAPOX is well tolerated and with promising efficacy in a broad gastric cancer patient population with tumors expressing Claudin18.2, including medium and high expressors. Furthermore, Transcenta has also developed a proprietary IHC assay to select patients with Claudin18.2 expressing tumors for registration enabling studies. Despite progresses in the treatment of advanced gastric cancer with HER2, VEGF, VEGFR, or PD-1/PD-L1 targeted therapies, outcomes remain poor for 1st line patients with median overall survival of around 14 months. Claudin18.2 expression is observed at various levels in 50%-70% of gastric cancer patients, and at relatively high percentage in a variety of tumors including pancreatic, cholangiocarcinoma, ovarian and lung cancer. It is one of the hottest targets in cancer treatment. A few Claudin18.2 directed targeted drugs have entered the clinical stage, including monoclonal antibodies, bispecific antibodies, CAR-T and antibody-drug couples (ADCs). TST001, a humanized anti-Claudin18.2 monoclonal antibody, with higher target binding affinity and enhanced ADCC activity than other antibodies, has demonstrated very encouraging preliminary signs of activity in 1st L gastric / GEJ cancers with various levels of CLDN18.2 expression, and a manageable safety and tolerability profile.Since entering into the clinical stage, Transcenta has attracted the attention of many multinational corporations. It established a global clinical collaboration with Bristol-Myers Squibb to evaluate the combination of TST001 with Opdivo(R) (Bristol-Myers Squibb's anti-PD-1 therapy) for the treatment of patients with unresectable locally advanced or metastatic G/GEJ cancer earlier in March this year. These TST001 data have also generated a lot of excitement from GI cancers investigators who see TST001 as an effective new treatment option to cover the high unmet need of Claudin18.2 medium and high expressors cancers, providing a broader treatment option than other players in the same class. As TST001 data continue to mature, Transcenta progresses TST001 towards phase III trial and has initiated Health authority consultations. 2. Dr. Caroline Germa, former AstraZeneca Oncology's Vice President, is now Transcenta's Chief Medical Officer as the Company accelerates its expansion internationallyIn August 2022, Transcenta announced the appointment of Dr. Caroline Germa as the Executive Vice President, Global Medicine Development and Chief Medical Officer. Dr. Caroline Germa was formerly Vice President of AstraZeneca Oncology and has extensive oncology development experience. Prior to joining AstraZeneca, she also worked for a number of world-renowned companies including Pfizer and Bristol-Myers Squibb, and led the late-stage clinical development of a number of key oncology assets, in particular the global registration strategy and approval of blockbuster drugs including Ribociclib (CDK4/6 inhibitor - Kisqali) and Neratinib. She has a deep understanding of the industry and, with her pharmaceutical industry contacts and unique ideas on the business development of the Company, international clinical development and regulatory approvals, the Company is confident that Dr Caroline Germa will be able to lead Transcenta to better global expansion and make a significant contribution to enhancing the Company's shareholder value.3. TST001 is ranked among the top two most advanced clinical programs for Claudin18.2 worldwide, and the first in ChinaZolbetuximab is the first clinical stage anti-claudin18.2 monoclonal antibody. In a phase II, randomized study evaluating Zolbetuximab + epirubicin + oxaliplatin + capecitabine (EOX) for the first-line treatment of CLDN18.2 positive advanced G/GEJ cancer or esophageal adenocarcinoma, zolbetuximab plus EOX chemotherapy showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone in the overall population, padding the Claudin18.2 target's potential for druggability. TST001 of Transcenta is a second generation anti-Claudin18.2 antibody with a differentiated profile relative to Zolbetuximab. It not only has 10-folds higher affinity binding to Claudin18.2, but also has a reduced fucose profile in the Fc of the humanized antibody. Combining these features, the ADCC activity of TST001 is 30-100 folds higher compared to Zolbetuximab analogue in tumor cells expressing various levels of Claudin18.2, which translated into much more potent in vivo anti-tumor activity, in particular, for those tumors expressing medium or low levels Claudin18.2. TST001 is being developed in parallel in China and the US and is currently in Phase II clinical studies. It is expected to start the global pivotal trial for TST001 during the Mid-2023. In the meantime, Transcenta will continue to evaluate other combination therapies as well as other indications. As the Company continues to accelerate its clinical development and commercialization, Transcenta will eventually better realize more of its potential with its outstanding platform, increase the shareholder value and develop innovative drugs that will benefit patients worldwide. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

6 9 月, 2022

Oculis announces publication and presentation of Phase 2 data showing topical OCS-01 improves macular thickness and visual acuity in patients with diabetic macular edema

LAUSANNE, Switzerland, Sep 6, 2022 - (ACN Newswire via SEAPRWire.com) - Oculis S.A., ('Oculis') a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, announces that the Phase 2 DX-211, a randomized, double blinded, multi-center and vehicle controlled clinical trial assessing the safety and efficacy of topical OCS-01 in patients with Diabetic Macular Edema (DME) (NCT05343156) has been published by the Acta Ophthalmologica journal. The publication is accessible on the National Institutes of Health (NIH) website here ( https://pubmed.ncbi.nlm.nih.gov/35848336/ ). In addition, a new subgroup analysis of this study was also recently presented by Pr R. Tadayoni at the 22nd EURETINA Congress on 2nd September in Hamburg, Germany.-- Positive Phase 2 data, published in journal ACTA, provides the first proof-of-concept for a topical drug effect in diabetic macular edema (DME) -- Dataset shows that OCS-01 eye drops were more effective than vehicle in reducing central macular thickness and improving visual acuity in patients with DME as per the pre-defined criteria for statistical superiority in the study protocol-- Subgroup analysis, presented by Pr Ramin Tadayoni at EURETINA, suggests even greater improvement in patients with lower baseline visual acuity-- If approved, OCS-01 has the potential to provide a new and potentially the FIRST non-invasive eye drop option for DME patientsThe dataset published shows OCS-01 to be superior to vehicle in the primary efficacy analysis of BCVA change from baseline with a between group difference of +1.58 ETDRS letters at the pre-specified significance level of 0.15. Mean CMT showed a statistically significant greater decrease from baseline in the OCS-01 group compared to vehicle at all post-baseline time points up to and including Week 12 (-54micrometer OCS-01 vs. -17micrometer vehicle) and reversed towards baseline when treatment stopped at 12 weeks, demonstrating the pharmacological effect of OCS-01 on retinal edema. OCS-01 was well tolerated and no significant or unanticipated ocular adverse events were observed.Subgroup analysis in patients with BCVA baseline is less than or equal to 65 letters, presented at EURETINA 2022, showed greater improvements in both CMT (-77.4micrometer OCS-01 vs. -23.1micrometer vehicle) and BCVA (+2.9 ETDRS letters in OCS-01 vs vehicle) at week 12.Approximately 37 million people are affected by DME worldwide, representing around 7% of the large and growing diabetes patient population. DME is the build-up of fluid (edema) in the macula (the macula is important for the sharp, straight-ahead vision that is used for reading, recognizing faces, and driving). DME is the most common cause of vision loss among people with diabetic retinopathy and a leading cause of new cases of blindness in US adults. Although treatment options currently exist, all of them are invasive (injections or implants) and represent a significant burden for patients and caregivers. OCS-01 is a novel, high concentration, preservative free, topical formulation of dexamethasone that has the potential to be the first topical eye drop and non-invasive treatment for DME. OCS-01 opens up the possibility of treating DME patients at all stages of disease with an eye drop. In addition, OCS-01 could increase the accessibility to treatment of those patients without easy access to specialists; together, this could significantly reduce the burden to the health care system and improve patient outcomes and quality of life.OCS-01 is currently under investigation for the treatment of DME in the ongoing Phase 3 DIAMOND trial to confirm these findings in a larger patient population. Riad Sherif, M.D., CEO of Oculis, said: "We are delighted by these data from the Phase 2 DX-211 study, which further reinforce the potential of OCS-01 to provide patients with a potentially transformative treatment of DME as the first non-invasive, eye drop, option. An effective topical treatment for DME could expand the proportion of patients treated, especially those with recent onset DME, as well as provide a treatment option to general ophthalmologists prior to referral to a retina specialist and thereby, improving access to treatment. We look forward to the results of the ongoing Phase 3 DIAMOND trial as Oculis seeks to deliver life-changing treatments that can be accessed globally for the world's most prevalent ocular diseases." Pr Ramin Tadayoni, MD, PhD, Professor of Ophthalmology at Universite de Paris, said: "The development of effective topical eye drops for posterior segment disorders such as DME would offer easier, non-invasive options than those currently available, and could be widely adopted across all socioeconomic and geographic boundaries. This would allow earlier treatment in DME, reduce the burden on both patients and their caregivers with potentially less injections per year if combined with current standard of care, increase adherence and ultimately, improve outcomes worldwide. OCS-01 is the most developed and promising topical therapy for DME to date, and I look forward to its further development as a potentially transformative treatment for patients in need."About OculisOculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.For more information, please visit: www.oculis.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

6 9 月, 2022

Eisai Presents New Data From its Oncology Portfolio and Pipeline at ESMO Congress 2022

TOKYO, Sep 6, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place virtually and in-person in Paris, France from September 9 to 13. A late-breaking oral presentation of detailed results from the LEAP (LEnvatinib And Pembrolizumab) clinical program including the final analysis of the Phase 3 LEAP-002 trial will be featured in a Proffered Paper session (NCT03713593; Presentation: #LBA34). The study evaluated the combination of lenvatinib plus anti-PD-1 antibody pembrolizumab from Merck & Co., Inc., Rahway, NJ, USA versus lenvatinib monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma. Additionally, two mini-oral presentations will feature updated efficacy and safety data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (NCT02811861; Presentation: #1449MO) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma (NCT03517449; Presentation: #525MO). In addition, a new post-hoc analysis of three pivotal Phase 3 studies (Study 301/NCT00337103, Study 304/NCT02225470 and the EMBRACE trial/Study 305/NCT00388726) evaluating the efficacy of eribulin (HALAVEN) versus other chemotherapies (capecitabine, vinorelbine and Treatment of Physician's Choice [TPC], respectively) in patients living with metastatic breast cancer whose tumors have low or no HER2-expression will be presented during a poster session (Presentation: #259P). "We look forward to presenting data at ESMO, showcasing Eisai's latest research on both lenvatinib and eribulin, with the goal of continuing to help people living with various types of cancer," said Dr. Takashi Owa, Chief Scientific Officer, Deep Human Biology Learning, Senior Vice President, Eisai Co., Ltd. "Presentations on the LEAP clinical program as well as new analyses for eribulin reinforce our commitment to the ongoing research of our portfolio in an effort to better serve patients and healthcare providers." In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with pembrolizumab. To date, more than 15 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types. This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.For more information, visit www.eisai.com/news/2022/news202265.html. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

4 8 月, 2022

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-002 Trial

TOKYO and RAHWAY, N.J., Aug 4, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada) today announced that the Phase 3 LEAP-002 trial investigating LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in OS and PFS for patients who received LENVIMA plus KEYTRUDA versus LENVIMA monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median OS of the LENVIMA monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating LENVIMA monotherapy in uHCC. The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported data on the combination. Eisai and Merck & Co., Inc., Rahway, NJ, USA plan to present these data at an upcoming medical conference."Our joint clinical development program for KEYTRUDA plus LENVIMA is designed to address unmet needs for some of the most challenging-to-treat types of cancer, like hepatocellular carcinoma," said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck & Co., Inc., Rahway, NJ, USA Research Laboratories. "We remain confident in the potential of this combination based on the body of evidence we've seen to date and will continue to investigate its role across multiple types of cancer.""Aiming for further improvement in the treatment of patients with unresectable HCC, we selected LENVIMA monotherapy, a standard of care option, as the control arm of the LEAP-002 trial," said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology at Eisai Inc. "While results evaluating the combination are not what we had hoped for, we will continue to contribute to the care of patients with unresectable HCC by applying valuable knowledge from the LEAP-002 trial."LENVIMA monotherapy is approved for the first-line treatment of patients with uHCC in the U.S., Europe, and China, and for patients with uHCC in Japan. The approval of LENVIMA was based on results of the Phase 3 REFLECT trial which evaluated the efficacy and safety of LENVIMA versus sorafenib for the first-line treatment of patients with uHCC.In the U.S., LENVIMA plus KEYTRUDA is approved for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation and for adult patients with advanced renal cell carcinoma (RCC) in the first-line setting. In Europe, LENVIMA (marketed as KISPLYX for RCC in the EU) plus KEYTRUDA is approved for adult patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum containing therapy in any setting and are not candidates for curative surgery or radiation and for adults with advanced RCC in the first-line setting. The LENVIMA plus KEYTRUDA combination is also approved in Japan for patients with radically unresectable or metastatic RCC and patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. Results from the LEAP-002 trial do not affect the current approved indications for the LENVIMA and KEYTRUDA combination.Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck cancer, biliary tract cancer, colorectal cancer, gastric cancer, esophageal cancer, glioblastoma and pancreatic cancer) across more than 15 clinical trials.For more information, visit www.eisai.com/news/2022/pdf/enews202259pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

8 6 月, 2022

Lemon Healthcare Uses Blockchain Technology to Improve the Smart Healthcare Ecosystem for Patients

Seoul, Korea,June8, 2022- (SEAPRWire) – Lemon Healthcare, a customized service platform, is using blockchain technology to improve the smart healthcare ecosystem for patients. The company is on a mission to create an efficient and convenient platform that allows patients to access medical records, manage appointments, and communicate with medical professionals. Additionally, the brand behind the platform has launched its own cryptocurrency, LEMONCHAIN (LEMC), which was recently first applied to a Blockchain-based Decentralized Distributed Application (DApp) called “Chung Gu-ui-Shin: All Mighty Reimbursement.” By using blockchain technology, Lemon Healthcare is able to simplify access to medical records and appointment management for patients and healthcare workers. “This innovative healthcare service platform will be a game-changer for the way patients and healthcare workers handle record-keeping, appointment setting, communication, billing, and more. With blockchain technology, we are able to reduce information asymmetry between medical institutions and patients, allowing consumers to actively participate in how their data is stored,” said Tony Lim, COO of Lemon Healthcare. “Our aim is for the Lemonchain ecosystem to become a standard blockchain protocol and platform in the global healthcare industry.” The Lemon Healthcare platform will make the medical experience easier for everybody involved. By fully digitizing healthcare service management, both patients and healthcare workers will be able to focus more on treatment and less on the paperwork and record-keeping that is required. This platform is already being utilized by 38 of the 45 biggest Class-A hospitals in Korea. The company received $5M VC funding in Series A (2018), $10M in Series B (2019), and $20M Pre IPO fund in April 2022, which will be used to fund the Lemonchain Healthcare overseas market expansion targeting China, US, Japan, and Europe. For more information about Lemon Healthcare, visit www.lemonhealthcare.com. Media Contact Company: Lemon Healthcare Contact: Kyle Kim Email: kyungho.kim@lemonhc.com Website: https://www.lemonhealthcare.com/ SOURCE: Lemon Healthcare The article is provided by a third-party content provider. SEAPRWire ( www.seaprwire.com ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Indonesia, Thailand, Vietnam, Singapore, Malaysia, Philippines & Hong Kong )

7 6 月, 2022

Hua Medicine Announces Dorzagliatin can Restore Glucose Sensitivity and Early Phase Insulin Secretion in T2DM and GCK-MODY Patients at ADA 2022

SHANGHAI, CHINA, Jun 7, 2022 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", stock code: 2552.HK) today announces that several clinical findings were presented on its global first-in-class drug, glucokinase activator (GKA) dorzagliatin, at the 82nd American Diabetes Association (ADA) Annual Scientific Sessions. A post-hoc analysis that involved two Phase III clinical trials of dorzagliatin indicated that dorzagliatin can significantly improve early phase insulin secretion and glucose sensitivity of patients of Type 2 diabetes (T2D).Professor Wenying Yang of the China-Japan Friendship Hospital, and former Chairman of the Chinese Diabetes Society and currently serving as Vice President of the Asian Association for Study of Diabetes and Hua Medicine's medical team, conducted a multivariate logistic regression analysis of the two Phase III clinical trials of dorzagliatin monotherapy (SEED), for which she participated in, and metformin add-on (DAWN), for which she served as lead principal investigator. The analysis found significant correlation between subjects who reached blood glucose control rate after treatment and the improvement in select key measures of beta-cell secretion function, such as early phase insulin secretion index and disposition index. The study further indicated that as a global first-in-class GKA drug, dorzagliatin can restore the deteriorated glucose sensing function of glucokinase (GK) in T2D patients, systematically improve islet beta-cell function, improve early phase insulin secretion and glucose sensitivity, and thereby restore the ability of T2D patients to regulate blood glucose autonomously and promote glycosylated hemoglobin levels in T2D patients (HbA1cConducted by Professor Jianhua Ma, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, the results of the DREAM study were also presented at ADA 2022. It is the first time that the result on diabetes remission of dorzagliatin was presented at an international academic conference, attracting widespread attention from the participants. The DREAM study is a non-drug intervention observational clinical study initiated by certain researchers participating in the SEED study. The main purpose of this study is to evaluate the remission of diabetes for 52 weeks after patients who completed the SEED study and whose blood glucose reached control targets, and stopped taking dorzagliatin as well as any other glucose-lowering medication. The results of the study showed that during the observation period when no anti-diabetes drugs were administered, the remission rate was 65.2% at 52 weeks. HbA1c, FPG and 2h-PPG levels were sustained during the 52 weeks after dorzagliatin discontinuation and beta-cell function remained stable. The study indicated that dorzagliatin has a promising treatment option for achieving remission of diabetes in newly diagnosed unmediated patients by rapidly restoring early phase insulin secretion and lasting improvement of beta-cell function.Another clinical study called SENSITIZE also provided clinical scientific data of dorzagliatin in improving insulin secretion and glucose sensitivity. The study, initiated by Professor Juliana Chan, an internationally recognized endocrinologist from the Chinese University of Hong Kong, explored the effects of dorzagliatin on patients with recent onset T2D and glucokinase-maturity-onset diabetes of the young (GCK-MODY or MODY-2). The study results of SENSITIZE were presented to the public for the first time at the ADA Annual Scientific Sessions. The study results, using glucose clamp technique, showed that dorzagliatin can significantly improve second phase insulin secretion and glucose sensitivity in GCK-MODY patients and can significantly improve basal insulin secretion rates in patients with recent onset T2D. As the speaker of the oral presentation and one of the researchers of the SENSITIZE study, Professor Elaine Chow from the Chinese University of Hong Kong, won the 2022 Women's Interprofessional Network of the American Diabetes Association (WIN ADA) abstract award in the category of Clinical Diabetes, Epidemiology, and Diabetes Complications in recognition of her outstanding results and significant contributions in the SENSITIZE study and the whole field of diabetes research. The potential application of dorzagliatin in this special rare disease population of GCK-MODY, has attracted the attention of the international diabetes research field.The WIN ADA abstract award category of Clinical Diabetes, Epidemiology, and Diabetes Complications is an important part of WIN ADA awards, voted by WIN ADA Advisory Group, consisting of expert clinicians, scientists, educators, public health practitioners, and other diabetes professionals. The awards are established to recognize outstanding women who have made significant contributions to diabetes research, clinical care, public health, education, and related areas.Dr. Li Chen, Founder, CEO and Chief Scientific Officer of Hua Medicine, said, "In 2012, Hua Medicine proposed the development of GKA based on the concept of glucose homeostasis, the core of which is to treat diabetes from the root cause of T2D, addressing the issues of glucose sensitivity and insulin resistance. Concept innovation is the main focus of new drug innovation research, and Hua Medicine has spent ten years to select a safe and effective dosing regimen and clinical study proposal suitable for most diabetic patients in China, thereby contributing to the successful development of GKA. The clinical findings presented at the ADA 2022 further demonstrate the scientific concept of dorzagliatin to 'repair the sensor, restore homeostasis, and treat the underlying cause of diabetes'. The findings also provide a scientific basis for studies on dorzagliatin monotherapy and as a cornerstone drug in combination with other OADs for the treatment of T2D, as well as for achieving remission and regression of diabetes in patients with recent onset of T2D, and boost our confidence to further personalize diabetes treatment and to cure diabetes."About DorzagliatinDorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive and degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By fixing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registered trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin respectively have been completed in China, as well as the studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). In an investigator-initiated study named as DREAM, a 65.2% diabetes remission rate was observed when they stopped dorzagliatin and no other antidiabetes medication was taken during the 52-week study period. The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Medical Products Administration, and has submitted its NDA to the National Medical Products Administration in order to realize the "First in Global, Start from China" mission for the benefits of diabetic patients worldwide.About Hua MedicineHua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates global resources to explore breakthrough technologies and products and accelerate global innovation in diabetes care. Targeting the glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials, and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around the world.For more informationHua MedicineWebsite: www.huamedicine.comInvestorsEmail: ir@huamedicine.comMediaEmail: pr@huamedicine.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

6 6 月, 2022

Eisai Presents New Findings for Antibody Drug Conjugate Farletuzumab Ecteribulin at 2022 ASCO Annual Meeting

TOKYO, Jun 6, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today new investigational data from the platinum-resistant ovarian cancer (PROC) cohort expansion of a Phase 1 study (Study 101) evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb, farletuzumab ecteribulin (MORAb-202). The safety and efficacy findings are being featured in a poster discussion at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO22), a hybrid meeting in Chicago from June 3 to 7 (NCT03386942; Abstract: #5513). Farletuzumab ecteribulin is composed of Eisai's in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the folate receptor alpha (FRalpha), and Eisai's anticancer agent eribulin, a microtubule dynamics inhibitor, using an enzymatically cleavable linker. "We are encouraged by the clinical safety and efficacy results, as measured by the preliminary antitumor activity observed in patients with platinum-resistant ovarian cancer being treated with each dose of farletuzumab ecteribulin, and with varying levels of folate receptor alpha expression," said Shin Nishio, MD, PhD, Principal Investigator and Associate Professor, Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan. "Based on the data from pre-clinical studies, farletuzumab ecteribulin has the clinical potential to elicit a bystander effect through an enzymatically cleavable linker that releases a toxic payload from the antibody, therefore acting not only on the folate receptor alpha-positive cancer cells, but also the folate receptor alpha-negative cancer cells surrounding the folate receptor alpha-positive cancer cells. As the field of targeted therapy continues to evolve, antibody drug conjugates are anticipated to become a key modality in the treatment of recurrent, platinum-resistant disease." Ovarian cancer is typically diagnosed at advanced stages of disease, with most patients facing a poor prognosis because of high rates of recurrence and subsequent development of chemoresistance.(1) High-grade serous ovarian cancer (HGSOC) is the most common type of ovarian cancer and tends to spread before it can be detected.(2)(3) Ovarian tumors express a great number of tumor-antigens that can be used to guide targeted medicines, including the FRalpha biomarker, which is often overexpressed in epithelial ovarian carcinomas.(4),(5) FRalpha is considered as a marker of tumor aggressiveness and is associated with poorer response rates to treatment.(6)"As part of our human health care mission, Eisai remains dedicated to exploring novel treatment approaches with the goal of addressing unmet needs of people living with cancer," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "The data for our first antibody drug conjugate, which was discovered in-house with Eisai technology, demonstrate the company's commitment to working to advance precision medicine to improve care for women in need of additional treatment options. We look forward to sharing further results assessing farletuzumab ecteribulin as a potential treatment for patients with platinum-resistant ovarian cancer." Trial DesignThe primary objective of this Phase 1 study conducted in Japan (Study 101) was to determine the safety and tolerability of farletuzumab ecteribulin. Selected secondary objectives included determining the recommended dose of farletuzumab ecteribulin for future studies, pharmacokinetic characterization and an efficacy assessment, including objective response rate (ORR) and disease control rate (DCR). Doses of farletuzumab ecteribulin from 0.3 to 1.2 mg/kg, administered by intravenous (IV) fusion every 3 weeks (Q3W), were then evaluated. The dose-escalation part of Study 101 suggested that treatment with farletuzumab ecteribulin led to antitumor activity in patients with FRalpha-positive solid tumors, including patients with ovarian cancer. Based on the efficacy and safety results from the dose-escalation part of this study, farletuzumab ecteribulin 0.9 mg/kg (Cohort 1) and 1.2 mg/kg (Cohort 2) administered by IV fusion Q3W were selected for the expansion part of this study in patients with platinum-resistant ovarian cancer. Patients were required to have FRalpha-positive tumors, assessed by immunohistochemistry assay, with positive expression defined as > 5% of cells stained on a slide at 1+, 2+ or 3+ intensity level. In the expansion phase of this study, tumor assessments were performed based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at baseline and every 6 weeks until week 36, thereafter every 8 weeks, and at treatment discontinuation (or as clinically indicated). Complete and partial responses required confirmation of the next response at >/= 4 weeks. Interstitial lung disease (ILD)/pneumonitis assessment in 0.9 mg/kg dose group was performed by external ILD experts committee before moving to 1.2 mg/kg dose group. In the case of ILD/pneumonitis, dosing of farletuzumab ecteribulin could be modified, interrupted or permanently discontinued depending on the severity. Other management options for ILD/pneumonitis included pulmonology consult, radiographic imaging, monitoring for signs and symptoms, prednisolone administration, or treatment according to local practice guidelines. Safety and Efficacy ResultsInterstitial lung disease/pneumonitis was the most common treatment-emergent adverse event (TEAE) (Cohort 1: 37.5%; Cohort 2: 66.7%) and was of low-grade severity in most patients in Cohort 1 (Grade 1: 33.3%; Grade 2: 4.2%; Grades 3-5: 0) and Cohort 2 (Grade 1: 28.6%; Grade 2: 33.3%; Grade 3: 4.8%; Grades 4-5: 0). The next most common TEAEs of any grade after ILD were pyrexia (Cohort 1: 33.3%; Cohort 2: 42.9%, headache (Cohort 1: 12.5%; Cohort 2: 47.6%) and nausea (Cohort 1: 25.0%; Cohort 2: 33.3%). Grade >/= 3 TEAEs occurred in 33.3% of patients in Cohort 1 and 28.6% of patients in Cohort 2. Treatment with farletuzumab ecteribulin resulted in an ORR of 25.0% (6 patients) in Cohort 1 (n=24) and 52.4% (11 patients) in Cohort 2 (n=21). In patients with HGSOC, ORR was 31.6% (6 out of 19 patients) in Cohort 1 and 50.0% (10 out of 20 patients) in Cohort 2. For patients with FRalpha-expression levels of less than 50.0%, treatment with farletuzumab ecteribulin led to an ORR of 33.3% (2 out of 6 patients) in Cohort 1 and 50.0% (1 out of 2 patients) in Cohort 2. For patients with FRalpha;-expression levels of greater than or equal to 50.0%, treatment with farletuzumab ecteribulin led to an ORR of 22.2% (4 out of 18 patients) in Cohort 1 and 52.6% (10 out of 19 patients) in Cohort 2.For more information, visit www.eisai.com/news/2022/news202245.html. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

27 5 月, 2022

Eisai Contributes to the Science of Cancer Medicine at ASCO 2022

TOKYO, May 27, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO22), which is taking place virtually and in-person in Chicago from June 3 to 7. Notable presentations include a poster discussion of safety and efficacy data (NCT03386942; Abstract: #5513) from the platinum-resistant ovarian cancer cohort expansion of a Phase 1 study evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb (Headquarters: the United States), farletuzumab ecteribulin (MORAb-202), as well as a poster presentation featuring dose optimization findings for farletuzumab ecteribulin (NCT03386942; Abstract: #3090)."Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "Eisai's first antibody drug conjugate combines our in-house developed anti-folate receptor alpha antibody and our anticancer agent eribulin using an enzyme cleavable linker, illustrating our dedication to building on our medicines to improve cancer care for more patients."New research from the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, includes subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (RCC) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma (EC). A poster discussion will evaluate the impact of subsequent therapies in patients with advanced RCC receiving the combination (NCT02811861; Abstract: #4514); while a poster presentation will discuss the efficacy of next line therapy after treatment with lenvatinib plus pembrolizumab in advanced EC (NCT03517449; Abstract: #5587)."The combination of lenvatinib plus pembrolizumab has helped to expand physicians' arsenal of treatment options for patients living with advanced renal cell carcinoma and advanced endometrial carcinoma around the world," said Richard C. Woodman, MD, Chief Clinical Officer, Oncology Business Group at Eisai. "Our data at ASCO 2022 demonstrate our commitment to continuing to investigate the combination through post-hoc analyses with the goal of providing healthcare professionals with tools to support them in making better-informed treatment decisions for their patients."In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co- development and co-commercialization of lenvatinib, both as monotherapy and in combination with pembrolizumab. To date, more than 20 trials have been initiated under the LEAP clinical program, which is evaluating the combination across more than 10 different tumor types.In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of farletuzumab ecteribulin, a folate receptor alpha (FRα)-targeting ADC. Eisai and Bristol Myers Squibb are currently investigating farletuzumab ecteribulin in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States.This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.For more information, visit www.eisai.com/news/2022/pdf/enews202241pdf.pdf.Media Inquiries:Public Relations DepartmentEisai Co., Ltd. +81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

30 3 月, 2022

Most long Covid patients will recover, but those with severe symptoms should seek help: Experts

29 3 月, 2022

Eisai: Announcement About an Approval for Additional Indication of Jyseleca, JAK inhibitor

TOKYO, Mar 28, 2022 - (JCN Newswire via SEAPRWire.com) - Gilead Sciences K.K., Eisai Co., Ltd. and EA Pharma Co., Ltd. announced that Gilead acquired an approval of additional indication of Jyseleca (Generic name: Filgotinib, "Jyseleca"), Janus Kinase (JAK) inhibitor, for the treatment of patients with active moderate-to-severe ulcerative colitis in Japan. In September 2020, Jyseleca was approved for the treatment of patients with rheumatoid arthritis (including prevention of structural joint damage) who had an inadequate response to conventional therapies in Japan. The approval of the additional indication is based on the data from Phase IIb/III SELECTION trial evaluating the efficacy and safety of Jyseleca in the induction and maintenance treatment of biologic-naive and biologic-experienced patients with moderately to severely active ulcerative colitis. The trial comprises of two induction studies and one maintenance study. The trial showed the efficacy and safety profile of Jyseleca, and no new safety risks were identified. Dr. Norifumi Hibi, Director of the Center for Advanced Treatment of Inflammatory Bowel Disease at Kitasato Institute Hospital, commented "Ulcerative colitis is a chronic inflammatory disease with sores and ulcers forms on the lining of the large intestine, and it accompanies by symptoms such as blood in stool, diarrhea and abdominal pain during the active stage. Despite advances in the treatment of ulcerative colitis, there is no curative treatment, and it is important to promptly induce remission and maintain remission to prevent relapse of inflammation. Because of persistent inflammation, there remains unmet medical needs as many patients still suffer from symptoms that affect their daily lives. With the approval for the additional indication, which showed the efficacy and safety in the induction and maintenance of remission, I am pleased that it provides a new treatment option for patients with unmet medical needs." Dr. Mamoru Watanabe, Vice president of Tokyo Medical and Dental University, commented "Jyseleca is a new JAK inhibitor and in clinical studies, the efficacy and safety profile of Jyseleca for induction and maintenance of remission were demonstrated in patients with moderately to severely active ulcerative colitis who are biologic- naive and biologic-experienced. With the approval for the additional indication, I expect to see further progress in the treatment of ulcerative colitis." Gilead and Eisai co-market Jyseleca for rheumatoid arthritis indication in Japan. Gilead and EA Pharma, which has been commissioned by Eisai, will co-promote the additional indication of ulcerative colitis. Gilead, Eisai and EA Pharma will expand the therapeutic options for ulcerative colitis and strive to further contribute to improving the QOL of patients and their families through Jyseleca.For more information, visit https://www.eisai.com/news/2022/news202223.html. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

25 3 月, 2022

Innovative AI Technology Aids Personalized Care for Diabetes Patients Needing Complex Drug Treatment

Tokyo and Salt Lake City, Indianapolis, Mar 25, 2022 - (JCN Newswire via SEAPRWire.com) - Hitachi, Ltd. (TSE: 6501), University of Utah Health (U of U Health), and Regenstrief Institute, Inc. (Regenstrief) today announced the development of an AI method to improve care for patients with type 2 diabetes mellitus who need complex treatment. One in 10 adults worldwide have been diagnosed with type 2 diabetes, but a smaller number require multiple medications to control blood glucose levels and avoid serious complications, such as loss of vision and kidney disease.Image of the AI grouping patients and analyzing the treatment patterns & efficacyFor this smaller group of patients, physicians may have limited clinical decision-making experience or evidence-based guidance for choosing drug combinations. The solution is to expand the number of patients to support development of general principles to guide decision- making. Combining patient data from multiple healthcare institutions, however, requires deep expertise in artificial intelligence (AI) and wide-ranging experience in developing machine learning models using sensitive and complex healthcare data.Hitachi, U of U Health, and Regenstrief researchers partnered to develop and test a new AI method that analyzed electronic health record data across Utah and Indiana and learned generalizable treatment patterns of type 2 diabetes patients with similar characteristics. Those patterns can now be used to help determine an optimal drug regimen for a specific patient.Some of the results of this study are published in the peer-reviewed medical journal, Journal of Biomedical Informatics, in the article, "Predicting pharmacotherapeutic outcomes for type 2 diabetes: An evaluation of three approaches to leveraging electronic health record data from multiple sources". (bit.ly/3NvD7BE)Hitachi had been working with U of U Health for several years on development of a pharmacotherapy selection system for diabetes treatment(1) . However, the system was not always able to accurately predict more complex and less prevalent treatment patterns because it did not have enough data. In addition, it was not easy to use data from multiple facilities, as it was necessary to account for differences in patient disease states and therapeutic drugs prescribed among facilities and regions. To address these challenges, the project partnered with Regenstrief to enrich the data it was working with.The new AI method initially groups patients with similar disease states and then analyzes their treatment patterns and clinical outcomes. It then matches the patient of interest to the disease state groups and predicts the range of potential outcomes for the patient depending on various treatment options. The researchers evaluated how well the method worked in predicting successful outcomes given drug regimens administered to patients with diabetes in Utah and Indiana. The algorithm was able to support medication selection for more than 83 percent of patients, even when two or more medications were used together.In the future, the research team expects to help patients with diabetes who require complex treatment in checking the efficacy of various drug combinations and then, with their doctors, deciding on a treatment plan that is right for them. This will lead not only to better management of diabetes but increased patient engagement, compliance, and quality of life.The three parties will continue to evaluate and improve the effectiveness of the new AI method and contribute to future patient care through further research in healthcare informatics.Hitachi will accelerate efforts, including the practical application of this technology through collaboration between its healthcare and IT business divisions and R&D group. GlobalLogic Inc., a Hitachi Group Company and leader in Digital Engineering, is promoting healthcare- related projects in the U.S., will also deepen the collaboration in this field. Through these efforts, the entire Hitachi group will contribute to the health and safety of people.(1) Hitachi, Ltd. news release, March 12, 2018 "Pharmacotherapy Selection System Supports Shared Clinician- patient Decision-Making in Diabetes Treatment" bit.ly/3Ld97Z7Hitachi, Ltd. news release, February 27, 2019 "New Clinical Study Tests Pharmacotherapy Selection System that Aims to Improve the Impact of Diabetes Treatment" bit.ly/3wJ1Ax4About Hitachi, Ltd.Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business. Hitachi is focused on strengthening its contribution to the Environment, the Resilience of business and social infrastructure as well as comprehensive programs to enhance Security & Safety. Hitachi resolves the issues faced by customers and society across six domains: IT, Energy, Mobility, Industry, Smart Life and Automotive Systems through its proprietary Lumada solutions. The company's consolidated revenues for fiscal year 2020 (ended March 31, 2021) totaled 8,729.1 billion yen ($78.6 billion), with 871 consolidated subsidiaries and approximately 350,000 employees worldwide. For more information on Hitachi, please visit the company's website at https://www.hitachi.com.About University of Utah HealthUniversity of Utah Health provides leading-edge and compassionate medicine for a referral area that encompasses 10% of the U.S., including Idaho, Wyoming, Montana and much of Nevada. A hub for health sciences research and education in the region, U of U Health has a$428 million research enterprise and trains the majority of Utah's physicians, including more than 1,250 health care providers each year at its Schools of Medicine and Dentistry and Colleges of Nursing, Pharmacy and Health. With more than 20,000 employees, the system includes 12 community clinics and four hospitals. For ten straight years, U of U Health has ranked among the top 10 U.S. academic medical centers in the Vizient Quality and Accountability Study. About Regenstrief InstituteFounded in 1969 in Indianapolis, the Regenstrief Institute is a local, national, and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute's research mission.Business Contacts:Research & Development Group, Hitachi, Ltd.bit.ly/3qw4CRyThe University of Utah Health 30N 1900ESalt Lake City, UT 84132 Julie Kiefer(801) 587-1293Julie.kiefer@hsc.utah.eduRegenstrief Institute 1101 West Tenth Street Indianapolis, IN 46202 John Erickson(317) 643-2313joerick@regenstrief.org Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

14 3 月, 2022

IND Application for SinoMab’s First-in-Class Asthma Therapeutic Product SM17 Approved by FDA

HONG KONG, Mar 14, 2022 - (ACN Newswire via SEAPRWire.com) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, the Investigational New Drug application ("IND"), for the treatment of patients with asthma for Company's First-in-Class (FIC) therapeutic product SM17 (Humanized anti-IL17RB monoclonal antibody for injection) was approved by the U.S. Food and Drug Administration ("FDA"). The IND approval would enable the Company to initiate the First-In-Human (FIH) study in the U.S. in the first quarter of 2022 at the earliest. SM17 is the world's first monoclonal antibodies targeting IL17BR co-developed by SinoMab and LifeArc (a medical research charity based in the United Kingdom), and is known to be the world's first humanized which has a wide range of indications, including asthma, idiopathic pulmonary fibrosis etc. SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB. The binding of SM17 to IL-17RB could suppress Th2 immune responses induced by interleukin-25, a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of airway viral responses and allergic disease, such as asthma. Patients with severe, uncontrolled asthma are at a risk of recurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality/morbidity, diminished quality of life and increased health expenditures. Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbation rates to a certain extent. However, there is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. The Company expected that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB, will have a broad effect on airway inflammation. The Company believes the huge potential of SM17 to satisfy unmet medical needs in asthma treatment. SM17 has obtained positive data in preclinical research, and it is expected to provide a broader and more beneficial effect on asthma treatment if it is successfully commercialized.Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The SM17 IND application was accepted by the FDA on February 11, 2022, and was approved only one month later, which fully reflects the FDA's recognition of the Company's candidate products, and also confirms the efficient execution of the Company's new drug R&D program. The number of asthma patients and the market size of asthma products in the world have expanded continuously, the number of asthma patients in the PRC is increasing at a greater pace than the global rate and the asthma market in the PRC is expected to reach RMB65.0 billion by 2030 that there is still a huge need for innovative asthma treatment products with efficacy and safety by patients. We are therefore confident in the enormous prospects of SM17's clinical development. With several core products entering the clinical stage, the Company is constantly moving towards commercialization. In the future, we will accelerate our projects implementation, devote to the vision of independent innovation, further expand the product portfolio and potential indications to bring benefits to patients and create value for shareholders."About SinoMab BioScience LimitedSinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

7 3 月, 2022

LENVIMA in Combination with KEYTRUDA Approved In Taiwan for the Treatment of Patients with Advanced Endometrial Carcinoma

TOKYO, Mar 7, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada)'s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial. These results were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer in March 2021, and published in the New England Journal of Medicine in January 2022.(1)In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p LENVIMA plus KEYTRUDA was previously approved under accelerated approval process in Taiwan, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation based on data from the Study 111/KEYNOTE-146 trial. In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from Study 309/KEYNOTE-775. Endometrial cancer is the most common type of uterine body cancer. It is considered that more than 90% of uterine body cancers occur in the endometrium.(3) Worldwide, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers in 2020.(4) In Taiwan, there were more than 2,700 new cases of uterine body cancer and nearly 400 deaths from the disease in 2018.(5) The five-year relative survival rate for metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.(6) Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals. *In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy pembrolizumab from Merck & Co., Inc., Kenilworth, N.J., U.S.A. About LENVIMA (lenvatinib mesylate)LENVIMA, discovered and developed by Eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in the United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it has been approved in combination with KEYTRUDA as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. In Japan, it has been approved in combination with KEYTRUDA as the treatment of patients with unresectable advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy and with radically unresectable or metastatic renal cell carcinoma. About Study 309/KEYNOTE-775 TrialThe approval was based on data from Study 309/KEYNOTE-775 (ClinicalTrials.gov, NCT03517449), a Phase 3 multicenter, open-label, randomized, active-controlled study conducted in 827 patients with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings. The primary efficacy outcome measures were OS, and PFS as assessed by blinded independent central review (BICR) according to RECIST v1.1. Patients were randomized 1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks) or investigator's choice, consisting of either doxorubicin (60 mg/m2 every three weeks) or paclitaxel (80 mg/m2 given weekly, three weeks on/one week off). Treatment with LENVIMA plus KEYTRUDA continued until RECIST v1.1-defined progression of disease as verified by BICR, unacceptable toxicity, or for KEYTRUDA, a maximum of 24 months. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. About the Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.In Taiwan, Eisai's pharmaceutical sales subsidiary Eisai Taiwan Inc. is marketing Lenvima and is co-commercializing it with a local branch of Merck & Co., Inc., Kenilworth, N.J., U.S.A. (1) V. Makker. et al. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. The New England Journal of Medicine. bit.ly/3HPQ59b(2) The information listed in Taiwanese Package insert(3) American Cancer Society, "Causes, Risks, Prevention." Endometrial Cancer. bit.ly/3HNy6jy(4) International Agency for Research on Cancer, World Health Organization. "Corpus uteri Fact Sheet." Cancer Today, 2020. bit.ly/35tT3TP(5) Taiwan Cancer Registry 2018 Report.(6) American Cancer Society, "Survival Rates for Endometrial Cancer." bit.ly/3hLZe8iMedia Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

26 2 月, 2022

Six polyclinics to be open for two weekends for patients with suspected Covid-19 symptoms

25 2 月, 2022

Eisai: LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Approved in Japan for Radically Unresectable or Metastatic Renal Cell Carcinoma

TOKYO and KENILWORTH, N.J., Feb 25, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for radically unresectable or metastatic renal cell carcinoma (RCC). LENVIMA plus KEYTRUDA is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC. This marks the second approval of this combination in Japan; in December 2021, LENVIMA plus KEYTRUDA was approved for unresectable, advanced or recurrent endometrial carcinoma that progressed after chemotherapy. The approval is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements versus sunitinib in the primary efficacy outcome measure of progression-free survival (PFS). Results showed LENVIMA plus KEYTRUDA (n=355) reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32-0.49]; p"Nearly one in three cases of renal cell carcinoma are diagnosed at an advanced stage,(1) and patients are in need of new treatment options that may improve survival outcomes,(2)" said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "In the CLEAR/KEYNOTE-581 trial, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 61% versus sunitinib, a current standard of care. We are encouraged that patients with certain types of advanced renal cell carcinoma may have the opportunity to benefit from this combination.""Today's milestone for LENVIMA plus KEYTRUDA as a treatment for radically unresectable or metastatic renal cell carcinoma is particularly exciting as it marks the second approval for the combination in Japan," said Terushige Iike, President of Eisai Japan, Senior Vice President, Eisai. "We are thrilled to be able to provide Japanese patients with a new treatment option, illustrating our shared commitment with Merck & Co., Inc., Kenilworth, N.J., U.S.A. to develop therapies with the aim of addressing the unmet needs of those living with difficult-to-treat cancers. We would like to thank the patients, families and healthcare providers who made this approval possible."The Japanese package inserts for LENVIMA and KEYTRUDA note that in the CLEAR/KEYNOTE-581 trial, adverse reactions were observed in 341 (96.9%) of 352 patients (including 42 of 42 Japanese patients) in the safety analysis set. The most common adverse reactions included diarrhea in 192 patients (54.5%), hypertension in 184 patients (52.3%), hypothyroidism in 150 patients (42.6%), decreased appetite in 123 patients (34.9%), fatigue in 113 patients (32.1%), stomatitis in 113 patients (32.1%), palmar-plantar erythrodysesthesia syndrome in 99 patients (28.1%), proteinuria in 97 patients (27.6%), nausea in 94 patients (26.7%), dysphonia in 87 patients (24.7%), rash in 77 patients (21.9%), and asthenia in 71 patients (20.2%).Renal cell carcinoma is the most common type of kidney cancer worldwide; about nine out of 10 kidney cancer diagnoses are RCC.(3) In Japan, there were more than 25,000 new cases of kidney cancer diagnosed and more than 8,000 deaths from the disease in 2020.(4) Approximately 30% of patients with RCC will have metastatic disease at diagnosis.(5) Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 14% for patients diagnosed with metastatic disease, the prognosis for these patients is poor.(6)Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. continue to study the LENVIMA plus KEYTRUDA combination across several types of cancer with more than 20 clinical trials.For more information, visit https://www.eisai.com/news/2022/pdf/enews202214pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)