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

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

18 1 月, 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)
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FDA Approves LEQEMBI (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer’s Disease JCN Newswire

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

9 1 月, 2023
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 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)
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Eisai to Present Latest Data on Perampanel at the 76th American Epilepsy Society (AES) Annual Meeting JCN Newswire

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

24 11 月, 2022
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)
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Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon JCN Newswire

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

2 11 月, 2022
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)
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Hua Medicine’s Innovative First-In-Class Glucokinase Activator (GKA) HuaTangNing Is Approved, New Type 2 Diabetes Treatment Paradigm to Begin in China

10 10 月, 2022
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)
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Claudin18.2, a shining star in gastric cancer, Transcenta’s TST001 stands at the global forefront

28 9 月, 2022
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)
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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 ACN Newswire

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

6 9 月, 2022
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)
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Eisai Presents New Data From its Oncology Portfolio and Pipeline at ESMO Congress 2022 JCN Newswire

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

6 9 月, 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)
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Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-002 Trial JCN Newswire

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

4 8 月, 2022
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)
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