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Eisai and Merck & Co., Inc. Present Results from Phase 3 LEAP-002 Trial Evaluating LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Versus LENVIMA Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

ruth
6 minutes

TOKYO and RAHWAY, N.J., Sep 12, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) today announced the first presentation of results from the final analysis of 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, as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). Results are being presented during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022, being held in Paris, France and virtually from Sept. 9-13 (abstract #LBA34).In the final analysis of the trial, there was a trend toward improvement for one of the study's dual primary endpoints, overall survival (OS), for patients treated with LENVIMA plus KEYTRUDA versus LENVIMA monotherapy; however, the results did not meet statistical significance per the pre-specified statistical plan (HR=0.84 [95% CI: 0.71-1.00]; p=0.0227). The median OS was 21.2 months (95% CI: 19.0-23.6...

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

ruth
4 minutes

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 t...

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

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3 minutes

TOKYO and KENILWORTH, N.J., Feb 25, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for radically unresectable or metastatic renal cell carcinoma (RCC). LENVIMA plus KEYTRUDA is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC. This marks the second approval of this combination in Japan; in December 2021, LENVIMA plus KEYTRUDA was approved for unresectable, advanced or recurrent endometrial carcinoma that progressed after chemotherapy. The approval is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements versus sunitinib in the primary efficacy outcome measure of progression-free survival (PFS). Results showed LENVIMA plus KEYTRU...

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Eisai: Results From Pivotal Phase 3 Study 309/KEYNOTE-775 Trial of LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) in Advanced Endometrial Carcinoma

ruth
3 minutes

TOKYO, Jan 20, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced 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...

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European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) for Patients With Certain Types of Endometrial Carcinoma

ruth
3 minutes

TOKYO and KENILWORTH, N.J., Nov 29, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission 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 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. This marks the first combination of tyrosine kinase inhibitor with immunotherapy approved in Europe for these patients with advanced or recurrent endometrial carcinoma. The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial, in which 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 "This approval is welcome news for patients in Europe, and i...

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European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Adult Patients With Advanced Renal Cell Carcinoma

ruth
13 minutes

TOKYO and KENILWORTH, N.J., Nov 29, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA (KISPLYX in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC]), 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 the first-line treatment of adult patients with advanced RCC.The approval for advanced RCC 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 efficacy outcome measures of progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32- 0.49]; p"A key focus of our collaboration with Eisai is to advance our clinical development program to evaluate the potential of KEYTRUDA plus LENVIMA to improve responses across different types of cancer, including renal cell ...

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FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for First-Line Treatment of Adult Patients with Advanced Renal Cell Carcinoma (RCC)

ruth
18 minutes

TOKYO and KENILWORTH, N.J., Aug 12, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) 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 the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).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 efficacy outcome measures of progression-free survival (PFS), overall survival (OS) and confirmed objective response rate (ORR). For PFS, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; p Adverse reactions, some of which can be serious or fatal, may occur with LENVIMA, including hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, renal failure or...

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Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

ruth
5 minutes

TOKYO and KENILWORTH, N.J., Jul 23, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) 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 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 in any setting and are not candidates for curative surgery or radiation.The approval for this population is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; p=0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.50-0.72]; pAdverse reacti...

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Hitachi High-Tech Launches the Easy-to-Use AFM100 and AFM100 Plus Atomic Force Microscopes

ruth
4 minutes

TOKYO, Jun 17, 2021 - (JCN Newswire via SEAPRWire.com) - Hitachi High-Tech Corporation announced the launch of both AFM100 and AFM100 Plus systems - entry-level and intermediate-level models of Hitachi's compact and versatile Atomic Force Microscopes (AFM). These tools are designed to offer ease of use and superior reliability for high-throughput R&D or quality control applications.AFM100 PlusThe AFM is a type of the Scanning Probe Microscope (SPM) that scan the surface of a sample using a sharp tip typically with a radius of a few nanometers (1 nanometer = 1/1,000,000 millimeter). The AFM can provide both high-resolution visualization of surface morphology and simultaneous mapping of various other physical properties at the nanoscale. Therefore, the AFM is intensively used for scientific research and development, as well as quality control across a wide range of industrial fields, such as examining battery materials, semiconductors, polymers, living organisms, etc.Conventional AFM operation could be quite time consuming and demanding. The workflow contains some mandatory steps such as loading a tiny cantilever (approximately 1 mm wide) manually with a tweezer to the target loc...

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Eisai: New Data on LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Versus Sunitinib

ruth
5 minutes

TOKYO and KENILWORTH, N.J., Jun 8, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. announced new investigational data from the pivotal Phase 3 CLEAR(Study 307)/KEYNOTE-581 trial, which evaluated the combinations 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., and LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Results from a new analysis evaluating health-related quality of life (HRQoL) based on patient-reported outcomes are being presented during an oral abstract session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502). Data from CLEAR/KEYTNOTE-581 were originally presented at the 2021 Genitourinary Cancers Symposium (ASCO GU) and published in the New England Journal of Medicine, and data from this trial are currently under review with the U.S. Food and Drug Administration (FDA)."This new analysis expands our understanding of the results we've seen from the CLEAR/KEYN...

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Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Priority Review From FDA for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Applications

ruth
4 minutes

TOKYO, May 7, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd.and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for 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. The first set of applications (a supplemental New Drug Application [sNDA] for LENVIMA and a supplemental Biologics License Application [sBLA] for KEYTRUDA) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581). The second set of applications are 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, based on PFS, OS, and OR...

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Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Uterine Body Cancer in Japan

ruth
2 minutes

TOKYO, Apr 23, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and MSD K.K., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) announced today an application submission in Japan for the additional indication of Eisai's in-house discovered and developed multiple receptor tyrosine kinase inhibitor, LENVIMA (generic name: lenvatinib mesylate), in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s KEYTRUDA (generic name: pembrolizumab) as a treatment for patients with advanced uterine body cancer.This application is based on the results of the pivotal Phase 3 Study 309/KEYNOTE-775 for the treatment of patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen, which were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer in March 2021. In this trial, LENVIMA plus KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS) as well as the secondary endpoint of Objec...

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LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

ruth
4 minutes

TOKYO, Feb 15, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced the first presentation of new investigational data from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581) in an oral presentation session (Abstract #269) at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine(1). The trial evaluated the combinations 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., and LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). LENVIMA plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS; HR=0.39 [95% CI: 0.32-0.49]; p"Continued efforts to improve outcomes in patients with advanced renal cell carcinoma are critical, considering that the number of people diagnosed with the disease has more than doubled over the last 50 years, a...

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Protect Your Family with the World’s First Intelligent CIO2 Air Purifier

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4 minutes

SINGAPORE, Jan 27, 2021 - (ACN Newswire) - Mamoru Marketing, the exclusive distributor of Ecom products in Singapore, is introducing a new product to protect our loved ones in 2021. The big brother of the EA Mask, the Ecom Mask 030 Plus Disinfection Air Purifier has 10 unique features that differentiates itself from the competition. It is the world's first professional-grade intelligent CIO2 air purification machine that will eliminate 99.9% of bacteria, smoke, odors, and more, ensuring you and your family will be breathing the best air of their lives.With the largest coverage of 1,000 square feet (the size of a 4 room HDB apartment), the Ecom Mask 030 Plus Disinfection Air Purifier uses 4-in-1 filtration technology, as well as displays that will show you the exact number of days to change the filters. The display will even show you immediately in precise PM2.5 recordings how the air quality has improved. It can even be wall-mounted to save space and is whisper-quiet at 25db.You can bring the Ecom Mask 030 Plus Disinfection Air Purifier home for an introductory price of just $1,280 (usual price $1,800). This also include a free Care Kit from worth $119. Mamoru is implementing a mon...

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LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination Demonstrated Statistically Significant Improvement in OS, PFS and ORR

ruth
4 minutes

TOKYO, Dec 17, 2020 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the pivotal Phase 3 Study 309/KEYNOTE-775 trial evaluating the investigational use 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., met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer, following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). Based on an analysis conducted by an independent Data Monitoring Committee, LENVIMA plus KEYTRUDA demonstrated a statistically significant and clinically meaningful impro...

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FE Credit to issue JCB Card in Vietnam

indie
2 minutes

HO CHI MINH & TOKYO, Nov 19, 2020 - (ACN Newswire) - VPBank Finance Company Limited (FE Credit) and JCB International Co., Ltd., the international operations subsidiary of JCB Co., Ltd., Japan's only international payment brand announced the launch of the FE Credit JCB Credit Card.FE Credit JCB Plus CardFE Credit JCB Gold CardThe new FE Credit JCB Card has 2 different card grades: FE Credit JCB Plus Card and FE Credit JCB Gold Card. The holders of FE Credit JCB Card can access JCB's acceptance network with about 34 million merchants around the world.FE Credit pioneered Credit Cards for category entrants and first time card users in Vietnam. These two products from FE Credit Card powered by JCB are loaded with features and benefits which resonate with the needs of the target segment. A few examples of these unique offerings are, Oi Plus Program - a flagship loyalty program that rewards cardholders on their everyday spending, EasyPay - one of Vietnam's largest 0% retail installment program, and Selfie PLUS - one-click mobile-to-card image upload solution.About FE CreditA pioneer in Consumer Finance, FE CREDIT has established a solid foundation to become the market leader in the u...