Lenvatinib

Eisai Commences Fully-Fledged Business Activities at Pharma Sales Subsidiary in South Africa

Retrieved on: 
Thursday, February 1, 2024
Lenvatinib, Lemborexant, Neglected tropical diseases, Life expectancy, African, EAC, Patient, Sales operations, SADC, Marketing, Southern African Development Community, Tropical medicine, Alzheimer's disease, Poverty, Dementia, Republic, Infection, Cancer, Malaria, Pharmaceutical industry

Commencement of Direct Sales Operations in Africa, and Establishment of Branch Office in Kenya

Key Points: 
  • Commencement of Direct Sales Operations in Africa, and Establishment of Branch Office in Kenya
    TOKYO, Feb 1, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that fully-fledged operations have begun at Eisai Pharmaceuticals Africa (Pty) Ltd ("Eisai South Africa"), a pharmaceutical sales subsidiary recently established in Johannesburg, South Africa, and direct sales operations and business activities have commenced in Africa.
  • Eisai South Africa is a wholly-owned subsidiary of Eisai.
  • Eisai South Africa has started sales and marketing activities directly for Lenvima and Fycompa from January 2024, as well as Halaven from February 2024.
  • Seeking solutions to these challenges in Africa, Eisai will continue its initiatives to deliver necessary medicines to the patients who need them through Eisai South Africa and Eisai Kenya.

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-001 Trial Evaluating LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
Monday, December 11, 2023
MSD, Pembrolizumab, Stomach, Lenvatinib, Hepatocellular carcinoma, Research, Carboplatin, Progression-free survival, MSI-H, Disease, Merck & Co., Standard of care, Head, RCC, Cancer, Merck, Patient, OS, PFS, Eisai, Paclitaxel, Esophageal cancer, LEAP, Senior, Pharmaceutical industry

The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination.

Key Points: 
  • The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination.
  • We are grateful to the patients, their loved ones, and the investigators whose participation is what makes scientific advancement possible."
  • LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of certain types of advanced endometrial carcinoma following prior systemic therapy in any setting and advanced renal cell carcinoma (RCC).
  • Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

Merck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
Friday, December 8, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MSD, Carboplatin, Paclitaxel, Research, NYSE, Hepatocellular carcinoma, Senior, Progression-free survival, Head, Merck & Co., LEAP, Disease, Cancer, Lenvatinib, Patient, PFS, Esophageal cancer, RCC, Standard of care, PMMR 62, Pembrolizumab, Stomach, OS, MSI-H, MRK, Pharmaceutical industry, Eisai, Merck

View the full release here: https://www.businesswire.com/news/home/20231208830310/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231208830310/en/
    At the final analysis, KEYTRUDA plus LENVIMA did not improve OS or PFS sufficiently to meet the study’s prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel).
  • The safety profile of KEYTRUDA plus LENVIMA was consistent with that observed in previously reported studies evaluating the combination.
  • The companies will work with investigators to share the results with the scientific community.
  • Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

Medivir announces updated formulation of fostrox, critical to support planned study with accelerated approval intent in second line HCC

Retrieved on: 
Monday, November 27, 2023
Quotient, Trial of the century, Liver cancer, HCC, Safety, Patient, Medivir, Cancer, Pharmaceutical industry, Lenvatinib

The need for new treatments is high and the development of an updated commercial formulation is an additional step towards fostrox becoming a treatment option for HCC patients.

Key Points: 
  • The need for new treatments is high and the development of an updated commercial formulation is an additional step towards fostrox becoming a treatment option for HCC patients.
  • The development efforts have been carried out by Quotient Sciences, Medivir's partner for formulation development and manufacture of drug product.
  • A formulation suitable for commercial manufacture is a critical component in clinical studies with regulatory intent.
  • - "With the plans to initiate a phase 2b study with registrational intent, it is imperative that we use the formulation intended for commercial launch in the study.

Eisai to Present Research from Oncology Portfolio and Pipeline at ESMO Congress 2023

Retrieved on: 
Wednesday, October 11, 2023
MSD, Congress, Senior, Hepatocellular carcinoma, Abstract, Pembrolizumab, Trial of the century, Bristol Myers Squibb, Merck & Co., Safety, Lung cancer, FR, Endometrial cancer, LEAP, Cancer, Fallopian tube cancer, Patient, FDA, ESMO, Oncology, Ovarian cancer, Meta-analysis, Merck, Research, Science, Lenvatinib, European Society for Medical Oncology, ADC, Pharmaceutical industry, Eisai

We also look forward to sharing data for lenvatinib and from our pipeline, as well as engaging in critical scientific exchange with the community in service of moving oncology research forward."

Key Points: 
  • We also look forward to sharing data for lenvatinib and from our pipeline, as well as engaging in critical scientific exchange with the community in service of moving oncology research forward."
  • A network meta-analysis of lenvatinib versus key comparators as first-line treatment for patients with unresectable hepatocellular carcinoma will also be presented during a poster session (Presentation: #1007P).
  • These abstracts will be made available via the ESMO website on Monday, October 16, 2023, at 12:05 AM CEST.
  • In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of FZEC.

Merck and Eisai Provide Update on Two Phase 3 Trials Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Friday, September 22, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Docetaxel, Senior, Hepatocellular carcinoma, RCC, Lenvatinib, Pembrolizumab, OS, MRK, Lung cancer, Head, Multimedia, NSCLC, Biomarker, PFS, Merck & Co., LEAP, Cancer, Patient, EGFR, Anaplastic lymphoma kinase, ROS1, Esophageal cancer, Stomach, Pemetrexed, NYSE, ORR, ALK, Pharmaceutical industry, Medical imaging, EU, Eisai, Merck

At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA plus LENVIMA with chemotherapy compared to KEYTRUDA with chemotherapy.

Key Points: 
  • At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA plus LENVIMA with chemotherapy compared to KEYTRUDA with chemotherapy.
  • Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or objective response rate (ORR), a key secondary endpoint.
  • At the final analysis of the study, there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel.
  • Results from the LEAP-006 and LEAP-008 trials do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

Medivir Hosts Expert Perspectives Webcast on the Evolving Treatment Landscape and the Unique Treatment Challenges in HCC

Retrieved on: 
Friday, September 1, 2023
AME Publishing Company, Lead, University, Medivir, Clifton Springs Hospital & Clinic, Cancer, DRS, Reig, Oncology, BCLC, Research, CMO, Cancer Science, Defence Scientific Advisory Council, ECMC, University of Glasgow, Liver cancer, Patient, School, Dr. Evan Alexander Erwin House, Webcast, Hospital, HCC, Lenvatinib, Disease, Pharmaceutical industry, Medical device, Beatson West of Scotland Cancer Centre

The webcast will feature presentations by Dr. Jeff Evans, Beatson West of Scotland Cancer Center, Glasgow, UK, who will discuss the current treatment landscape and unmet medical need in treating patients with HCC.

Key Points: 
  • The webcast will feature presentations by Dr. Jeff Evans, Beatson West of Scotland Cancer Center, Glasgow, UK, who will discuss the current treatment landscape and unmet medical need in treating patients with HCC.
  • He will be joined by Dr. Maria Reig, Liver Cancer Unit, Hospital Clínic BCLC group, Villarroel, Barcelona, Spain, who will discuss how HCC is different from many other tumor types and its unique treatment challenges.
  • Both Drs are investigators in the phase 1b/2a study with fostrox in combination with Lenvima and will also share their perspectives from the ongoing study.
  • The webcast will be streamed via a link on the website: www.medivir.com/investors/presentations The presentation will be available on Medivir´s website after the webcast.

Merck and Eisai Provide Update on Phase 3 LEAP-010 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Retrieved on: 
Friday, August 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Senior, Hepatocellular carcinoma, Progression-free survival, RCC, Neoplasm, Lenvatinib, Pembrolizumab, Overalls, Survival, OS, MRK, Head, TKI, Multimedia, Research, Lung cancer, Immunotherapy, PFS, Merck & Co., LEAP, Cancer, Patient, Esophageal cancer, HNSCC, Data monitoring committee, Stomach, PD-L1, NYSE, ORR, DMC, Pharmaceutical industry, EU, Eisai, Merck

The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).

Key Points: 
  • The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
  • View the full release here: https://www.businesswire.com/news/home/20230825671284/en/
    Two planned interim analyses were conducted by an independent Data Monitoring Committee (DMC) over an 11-month period.
  • In the first analysis, KEYTRUDA plus LENVIMA showed a statistically significant improvement in PFS and ORR versus KEYTRUDA plus placebo.
  • The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.

LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, May 26, 2023
MSD, Senior, Hepatocellular carcinoma, Pharming, Sunitinib, Survival, Head, DO, Cancer, Patient, Stomatitis, Risk, Merck, Fatigue, Texas Oncology, Diarrhea, Pembrolizumab, FACP, Research, Lung cancer, Merck & Co., Hypertension, LEAP, HIV disease progression rates, Esophageal cancer, Abstract, Death, Apoptosis, Lenvatinib, Overalls, PFS, Eisai, CR, Stomach, ORR, Acral lentiginous melanoma, Arm, Progression-free survival, RCC, CI, OS, Drug, Trae tha Truth, Hypothyroidism, ASCO, Central Time Zone, American Society of Clinical Oncology, Cancer Treatment Centers of America, Physician, Annual general meeting, Nausea, Society, Pharmaceutical industry, EU

After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for LENVIMA plus KEYTRUDA versus 69.6% and 60.2% for sunitinib, respectively.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received LENVIMA plus KEYTRUDA versus 60.3% of patients who received sunitinib.
  • These findings reinforce the important role of LENVIMA plus KEYTRUDA as a first-line standard of care treatment option for patients with advanced renal cell carcinoma."

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer

Retrieved on: 
Thursday, June 8, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Gastrointestinal cancer, AACR, Lenvatinib, TACE, Cholangiocarcinoma, MRK, American Association for Cancer Research, Cisplatin, Merck & Co., Eisai, Patient, Annual general meeting, PDUFA, BTC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, HCC, Food, Pharmaceutical industry, Merck

The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone.

Key Points: 
  • The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone.
  • Results from KEYNOTE-966 were presented at the American Association for Cancer Research (AACR) 2023 Annual Meeting.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of February 7, 2024.
  • “Most biliary tract cancers go undetected until an advanced stage, at which point many patients are ineligible for surgery and have few treatment options,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories.