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TOKYO, Mar 7, 2022 - (JCN Newswire) - 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<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 (PDGFR&#945;), 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.

TOKYO and KENILWORTH, N.J., Feb 25, 2022 - (JCN Newswire) - 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<0.0001), with a median PFS of 23.9 months versus 9.2 months for sunitinib (n=357).

"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.

Data published in Clinical and Translational Radiation Oncology Peer-reviewed clinical case study reported preliminary data on the first-in-human administration of NBTXR3 for the treatment of pancreatic cancer not eligible for surgery, demonstrating feasibility with no treatment-related toxicity Case study provides the first demonstration of local endoscopic delivery of NBTXR3 to a deep visceral tumor, and […]

The post Nanobiotix Announces Publication of New Clinical Case Study Highlighting First Patient Experience of NBTXR3 Treatment for Pancreatic Cancer appeared first on Fintech News.

Data published in the International Journal of Nanobiotechnology Peer-reviewed preclinical data in an anti-PD-1 resistant lung cancer model show that adding NBTXR3 to a combination of radiotherapy, anti-PD-1, and anti-CTLA-4 produced significant antitumor effects against both primary and secondary tumors, improved the mouse survival rate from 0 to 50%, and induced long term antitumor memory […]

The post NANOBIOTIX Announces Publication of New Preclinical Immunotherapy Data Showcasing the Combination Potential of NBTXR3 With anti-PD-1 and anti-CTLA-4 appeared first on Fintech News.

TOKYO, Jan 20, 2022 - (JCN Newswire) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced the publication of results from the Phase 3 Study 309/KEYNOTE-775 trial in the January 19, 2022 edition of the New England Journal of Medicine. The pivotal study evaluated 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. versus chemotherapy (treatment of physician's choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at-least one prior platinum-based regimen in any setting.

The publication includes previously reported data that was first presented in an oral plenary session at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer.(1) Results showed that the LENVIMA plus KEYTRUDA combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Objective response rate (ORR) data and additional detailed efficacy and safety data, including subgroup analyses, are also featured in the publication.

"While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. "KEYNOTE-775/Study 309 is an important Phase 3 study that supported recent approvals of KEYTRUDA plus LENVIMA for certain types of advanced endometrial carcinoma in the U.S. and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients."

"The Phase 3 Study 309/KEYNOTE-775 trial demonstrates the ongoing commitment that Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. share in addressing the unmet needs of people living with difficult-to-treat cancers, including advanced endometrial carcinoma," said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "The publication of this study in the New England Journal of Medicine reflects the importance of our joint research in exploring the potential of the LENVIMA plus KEYTRUDA combination."

The publication contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which LENVIMA plus KEYTRUDA is not approved in the U.S.

Based on the results from the Phase 3 Study 309/KEYNOTE-775 trial, LENVIMA plus KEYTRUDA has been approved in the U.S. for patients with advanced endometrial carcinoma that is not microsatellite instability-high or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. LENVIMA plus KEYTRUDA is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types across more than 20 clinical trials.

(1) Eisai co., Ltd. Home page. "LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Platinum-Based Chemotherapy in Phase 3 Study". https://www.eisai.com/news/2021/news202116.html

Eisai Co., Ltd.
Public Relations:
+81-(0)3-3817-5120
Investor Relations:
+81-(0) 70-8688-9685

Merck & Co., Inc., Kenilworth, N.J., U.S.A.
Media Relations
Melissa Moody: +1-(215) 407-3536
Nikki Sullivan: +1-(718) 644-0730
Investor Relations
Peter Dannenbaum: +1- (908) 740-1037
Raychel Kruper: +1-(908) 740- 2107

For more information, visit https://www.eisai.com/news/2022/news202207.html.


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 the publication of results from the Phase 3 Study 309/KEYNOTE-775 trial in the January 19, 2022 edition of the New England Journal of Medicine.

TOKYO, Jan 17, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI22), taking place in-person in San Francisco, California, and virtually, from January 20 to 22, 2022.

At this symposium, the results of a primary analysis of a prospective clinical study evaluating transcatheter arterial chemoembolization (TACE) therapy in combination strategy with lenvatinib (TACTICS-L) in patients with unresectable hepatocellular carcinoma (uHCC) in Japan (Abstract No: 417), as well as research updates on the Phase IV Study (STELLAR) to evaluate safety and tolerability of lenvatinib in patients with advanced/unresectable hepatocellular carcinoma (Abstract No: TPS485) and results from a clinical study to evaluate the efficacy of lenvatinib for conversion surgery in patients with uHCC (investigator-initiated study in Japan, Abstract No: 458), will be presented.

In addition, trial-in-progress (TiP) posters from the clinical program evaluating the combination therapy of lenvatinib plus pembrolizumab (product name: KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), include the Phase III LEAP-014 Study of the combination plus chemotherapy in patients with esophageal carcinoma squamous cell carcinoma (Abstract No: TPS367), Phase III LEAP-015 Study of the combination plus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma (Abstract No: TPS369), Phase III Study LEAP-012 of the combination plus TACE in patients with intermediate-stage hepatocellular carcinoma not amenable to curative treatment (Abstract No: TPS494), and Phase II Study of the combination plus belzutifan in patients with advanced solid tumors (Abstract No: TPS669).

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.

Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

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.

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.

Eisai's Focus on Cancer

Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

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 presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, 'lenvatinib") will be given at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI22), taking place in-person in San Francisco, California, and virtually, from January 20 to 22, 2022.