Tag: Merck
Breaking News
LENVIMA in Combination with KEYTRUDA Approved In Taiwan for the Treatment of Patients with Advanced Endometrial Carcinoma
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<0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 44% (HR=0.56 [95% CI, 0.47-0.66]; p<0.0001), versus chemotherapy (investigator's choice of doxorubicin or paclitaxel). The median OS was 18.3 months for LENVIMA plus KEYTRUDA versus 11.4 months for chemotherapy. The median PFS was 7.2 months for LENVIMA plus KEYTRUDA versus 3.8 months for chemotherapy. The objective response rate (ORR) was 32% (95% CI, 27-37) for patients treated with LENVIMA plus KEYTRUDA versus 15% (95% CI, 11-18) for patients treated with chemotherapy (p<0.0001). Patients treated with LENVIMA plus KEYTRUDA achieved a complete response (CR) rate of 7% and partial response (PR) rate of 25% versus a CR rate of 3% and a PR rate of 12% for patients treated with chemotherapy.(2) In this trial, the five most common adverse reactions (any grade) observed in the LENVIMA plus KEYTRUDA combination arm were hypothyroidism, hypertension, fatigue, diarrhea and musculoskeletal disorders.(2)
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 Trial
The 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 Collaboration
In 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/3hLZe8i
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai 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.
Insurance Broker Aon Investigating Cyber Incident
Global insurance broker Aon on Monday revealed that it’s investigating a cyber incident impacting some of its systems.
Eisai: LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Approved in Japan for Radically Unresectable or Metastatic Renal Cell Carcinoma
"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. www.jcnnewswire.comEisai 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.
Eisai Announces Results and Continued Support of Initiatives for Elimination of Neglected Tropical Diseases
 |
Tremendous achievements have been made through public-private partnership since the launch of the London Declaration to 2020. The pharma industry has contributed to the elimination of NTDs via supply of medicines which resulted in donation of 13 billion high-quality treatments. Forty-three countries have eliminated at least one NTD and 600 million people no longer require interventions against NTDs. Despite such progress, more than 1.7 billion people remain threatened by NTDs.
In the event, CEO Haruo Naito said, "Our initiatives toward NTDs elimination are rooted in the pharmaceutical company's fundamental mission to deliver medicines to those who need them to treat illness and save lives. While R&D for NTDs treatments have become more active after the London Declaration, establishment of agile and flexible regulatory approval system as well as expansion of funding which leverages public-private partnership will be required to accelerate further innovations. Utilization of digital technologies such as remote medicine will help ensure delivery of and access to healthcare service under the vulnerable social infrastructure."
Under the London Declaration, Eisai has been manufacturing and supplying diethylcarbamazine (DEC) tablets, one of the lymphatic filariasis (LF) treatments, free of charge to the WHO for the elimination of LF. To date, 2.05 billion DEC tablets manufactured at Eisai's Vizag Plant in India have been supplied to 29 countries (as of January 2022). Although LF has been eliminated in 17 countries and the number of infected people has declined by 74% since 2000, 860 million people worldwide are still exposed to the risk of infection. Eisai is committed to providing DEC tablets for free to endemic countries that need DEC until LF is eliminated in these countries. In addition to the supply of DEC tablets, Eisai is working on various initiatives such as support for the mass drug administrations (MDA), disease awareness and improvements in sanitation.
Furthermore, Eisai is proactively engaged in development of new treatments for NTDs through partnerships with global research organizations. Utilizing the funding from the Global Health Innovative Technology Fund (GHIT Fund) and others, Eisai is conducting joint development of new treatments such as a new treatment for LF in collaboration with the Liverpool School of Tropical Medicine and the University of Liverpool as well as treatments for mycetoma and leishmaniasis in collaboration with the Drugs for Neglected Diseases initiative (DNDi).
Eisai commits to the Kigali Declaration and strengthens collaborations with global partners to tackle NTDs towards the achievement of NTD road map 2021-2030.
Based on human health care (hhc) philosophy, Eisai seeks to contribute to the health and welfare of people in developing and emerging countries. Once they recover their health, they can resume productive activities, which will in turn contribute to economic development and expansion of the middle-income class. Eisai considers this to be a long-term investment in creating the markets for the future. Eisai is actively engaged in leveraging partnerships with governments, international organizations, academia, and non-profit private sector organizations to accelerate the development of new treatments for infectious diseases including NTDs and facilitate initiatives to improve access to medicine such as support for MDAs and disease awareness activities. Through these initiatives, Eisai seeks to further contribute to patients and their families worldwide and increase the benefits that health care provides.
About Neglected Tropic Diseases (NTDs)
Neglected Tropic Diseases (NTDs) include 20 diseases that the WHO identifies as tropical diseases which human race must overcome. More than 1.7 billion people living in the poorest and most marginalized communities worldwide are exposed to the risk of NTDs infection. The spread of NTDs is mainly caused by poor hygienic conditions associated with poverty. Infections from these diseases may result in serious physical impairment and this often results in normal economic and social activities becoming highly challenging to the individual. In the worst cases, NTDs may also result in death. The prevalence of NTDs is a stumbling block to economic growth for developing and emerging countries and represents a serious issue for these regions.
The following 20 NTDs have been designated by WHO for control or elimination: dengue and chikungunya, rabies, trachoma, buruli ulcer, yaws (endemic treponematoses], leprosy (Hansen's disease], Chagas disease, human African trypanosomiasis (sleeping sickness], leishmaniasis, taeniasis / cysticercosis, dracunculiasis (guinea-worm disease), echinococcosis, food-borne trematodiases, lymphatic filariasis, onchocerciasis (river blindness], schistosomiasis, soil-transmitted helminthiases, mycetoma, scabies and other ectoparasites, and snakebite envenoming.
About London Declaration on Neglected Tropical Diseases
On January 30, 2012, the CEOs of 13 pharmaceutical companies*, the Bill & Melinda Gates Foundation, WHO, the U.S. Agency for International Development (USAID), the U.K. Department for International Development (DFID), the World Bank, and officials from NTD-endemic countries gathered in London to pledge their support for a coordinated effort to combat 10 NTDs**. The London Declaration represents the largest international public-private partnership in the field of global health to date, and unlike past approaches undertaken by an individual organization or for a single disease, the group has committed itself to working collaboratively in an effort to comprehensively tackle issues pertaining to drug supply, distribution, development, and implementation programs as it seeks to more effectively combat NTDs.
Commemorating the London Declaration, January 30 has been designated as the World NTD Day since 2020 and campaigns are held worldwide to light up the iconic landmarks and monuments in orange and purple, the symbol colors of NTDs. Eisai is sponsoring the light up of Tokyo Tower to raise disease awareness and disseminate the importance of eliminating NTDs.
* Abbvie, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, GlaxonSmithKline, Gilead, Johnson & Johnson, Merck (Merck KGaA: Germany), Merck Sharp & Dhome, Novartis, Pfizer, Sanofi
** Guinea worm disease, lymphatic filariasis, blinding trachoma, sleeping sickness (human African trypanosomiasis], leprosy, soil-transmitted helminthes, schistosomiasis, river blindness, Chagas disease, and visceral leishmaniasis
About Kigali Declaration on Neglected Tropical Diseases
As the successor of the London Declaration on NTDs launched in 2012, the Kigali Declaration represents a collective commitment from stakeholders to fight against NTDs. With the endorsements from stakeholders being initiated at the online event entitled "100% COMMITTED to End NTDs", a campaign to commemorate the 10th year anniversary of the London Declaration held on January 27, 2022, the Kigali Declaration will be unveiled at the Commonwealth Heads of Government Meeting (CHOGM) scheduled for June 2022 in Kigali, the capital of the Republic of Rwanda. To achieve the WHO's NTD roadmap 2021-2030, the Kigali Declaration aims to tackle NTDs comprehensively and sustainably by sustaining a multisectoral and multidisciplinary approach through public-private partnership, strengthening country ownership including establishment of local health system and domestic financing, accelerating research and development of treatments and diagnostics for NTDs and ensuring equitable access to these NTDs related products and services.
About Lymphatic Filariasis
Lymphatic filariasis (LF) is an NTD transmitted to humans via carrier mosquitoes. LF causes lymphatic dysfunction and can lead to the swelling of body parts such as legs, and cause severe pain, permanent disability and social stigma associated with disfiguring visible manifestations. As a result, patients suffer mental, social and financial losses. It is estimated that 860 million people worldwide, mainly those in developing countries, are exposed to the risk of LF. Elimination of LF is possible by stopping the spread of the infection through MDAs of three types of LF treatments including DEC tablets.
About Eisai's Commitment to Improving Global Access to Medicines including LF Elimination Program
In line with its hhc philosophy, Eisai is committed to improving global access to medicines over the medium-to-long term through partnership strategies that involve working with governments, international organizations, private entities and non-profit organizations.
In November 2010, Eisai agreed to supply a total of 2.2 billion DEC tablets to the WHO free of charge by 2020, as there was a global shortage of high-quality DEC tablets for use in MDAs. In 2012, Eisai became the only Japanese company to participate in the London Declaration, a coordinated effort to eliminate 10 NTDs and the largest public-private partnership of its kind in the field of global health. At the London Declaration's fifth anniversary event held in April 2017, Eisai announced its plan to supply DEC tablets continuously beyond 2020, until LF is eliminated in all endemic countries where DEC tablets are needed.
Eisai has supplied 2.05 billion tablets to 29 countries through the WHO's elimination program (as of January 2022). Furthermore, in order to support the smooth implementation of the WHO's MDA programs, Eisai is engaging in initiatives to raise public awareness of LF in endemic countries. Staff members of Eisai Group cooperate with the relevant representatives in endemic countries to eliminate LF as early as possible.
In addition to the above-mentioned initiatives, Eisai is moving ahead with new drug development projects targeting malaria and NTDs such as mycetoma and LF, based on partnerships with international non-profit organizations such as the Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV), as well as research organizations such as Liverpool School of Tropical Medicine, University of Kentucky, and the Broad Institute (please refer to the table above).
Furthermore, Eisai co-established the Global Health Innovative Technology Fund (GHIT Fund), Japan's first public-private partnership to advance development of new health technologies for the developing world, is a member of the World Intellectual Property Organization (WIPO) Re:Search Consortium, an international joint enterprise for the development of treatments for NTDs, malaria and tuberculosis led by WIPO, is a signatory to the Tuberculosis Drug Accelerator (TBDA) partnership, and is participating in the Access Accelerated initiative to promote prevention and treatment of non-communicable diseases.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. announced today that its CEO Haruo Naito participated in the online event entitled "100% COMMITTED to End NTDs" celebrating the 10th anniversary of the London Declaration, an international public-private partnership to eliminate neglected tropical diseases (NTDs), on January 27, 2022.
Court Awards Merck $1.4B Insurance Claim Over NotPetya Cyberattack
New Jersey court delivers summary judgment against insurance company’s refusal to pay based on war exclusion clause
Latest Intelligence
