NYSE:MRK

Merck Initiates Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Certain Patients With Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, April 4, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Congress, Mutation, NSCLC, Progression-free survival, Patient, Neoplasm, Merck & Co., Cancer, Lung cancer, TPS, MRK, ESMO, Safety, Pharmacokinetics, PD-L1, Astex Pharmaceuticals, Pharmaceutical industry

“KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.

Key Points: 
  • “KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
  • The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response.
  • Preliminary safety and efficacy data from this trial were previously presented at the European Society for Medical Oncology (ESMO) Congress in 2023.
  • MK-1084 is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd.

REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer

Retrieved on: 
Wednesday, April 3, 2024
Pharmaceutical, Health, Oncology, Clinical Trials, MSD, DXD, CDH6, Survival, Glomus tumor, Patient, Merck & Co., SGO, MD, Society, Senior, MRK, Safety, Gynecologic Oncology (journal), Recurrence, ADC, Daiichi Sankyo, Annual general meeting, Pharmaceutical industry

The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.

Key Points: 
  • The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.
  • Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck.
  • “Raludotatug deruxtecan has shown promising activity in a phase 1 trial of patients with advanced ovarian cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.
  • “We look forward to working with our colleagues at Daiichi Sankyo to further evaluate the potential of raludotatug deruxtecan to provide a new treatment option for patients with platinum-resistant ovarian cancer.”

Merck to Hold First-Quarter 2024 Sales and Earnings Conference Call April 25

Retrieved on: 
Monday, April 1, 2024
Biotechnology, Pharmaceutical, Health, MSD, Webcast, MRK, News

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its first-quarter 2024 sales and earnings conference call with institutional investors and analysts at 9:00 a.m.
  • Investors, journalists and the general public may access a live audio webcast of the call via this weblink .
  • A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com .
  • All participants may join the call by dialing (888) 847-9708 (U.S. and Canada Toll-Free) or (630) 395-0358 and using the access code 4164932.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable Non-Small Cell Lung Cancer (NSCLC) at High Risk of Recurrence in Adults

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Civil service commission, OS, Lung cancer, Survival, Disease, Risk, Patient, Committee, Neoplasm, EFS, Merck & Co., Cancer, Death, MRK, European Commission, Recurrence, PD-L1, Marketing, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
  • For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen.
  • The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen.
  • KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU.

FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1)

Retrieved on: 
Tuesday, March 26, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, MSD, FC, Exercise, Breakthrough therapy, Blood, Risk, Patient, Orthostatic hypertension, MRK, World Health Organization, Heart, WHO, Multimedia, PAH, Food, Pharmaceutical industry

“The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.

Key Points: 
  • “The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association.
  • In the WINREVAIR treatment group, the placebo-adjusted median increase in 6MWD was 41 meters (95% CI: 28, 54; p
  • The median treatment difference in PVR between WINREVAIR and placebo was -235 dynes*sec/cm5 (95% CI: -288, -181; p
  • The median treatment difference in NT-proBNP between WINREVAIR and placebo was -442 pg/mL (95% CI: -574, -310; p

Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, March 21, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, OS, Pemetrexed, Chemotherapy, NSCLC, Progression-free survival, Patient, Carboplatin, Merck & Co., MRK, PARP, Cisplatin, PFS, Pharmaceutical industry

In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).

Key Points: 
  • In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).
  • The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies.
  • “These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer.
  • We sincerely thank the patients and investigators for their important contributions to this study.”

Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Retrieved on: 
Tuesday, March 19, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Emory University, Antigen, Streptococcus, International Society, HIV, Risk, Global health, Patient, Cohort, Hospital, Merck & Co., Aes, OPA, Epidemiology, Training school (United States), PCV20, Immunoglobulin G, Attenuated vaccine, MRK, Pediatrics, CDC, Vaccination, PPSV23, Community-acquired pneumonia, Food, FDA, PDUFA, Medicine, Vaccine

V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

Key Points: 
  • V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23.
  • V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116.

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival (OS) Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

Retrieved on: 
Friday, March 15, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, MSD, OS, Chemoradiotherapy, CRT, Obstetrics, Congress, Gynaecology, CPS, Survival, Disease, Progression-free survival, Data monitoring committee, Cervical cancer, Patient, Neoplasm, Merck & Co., Overalls, Humanitas University, Bevacizumab, MRK, Cancer, ESMO, PFS, FIGO, PD-L1, Food, Pharmaceutical industry

At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone.

Key Points: 
  • At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone.
  • The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
  • Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
  • As previously reported , KEYNOTE-A18 met its other primary endpoint of progression-free survival (PFS) in 2023.

Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Hypersensitivity, Pregnancy, Wart, Head, Congress, Recombinant, Multiple endocrine neoplasia, Dizziness, Safety, Vain, Headache, Bruise, Public, Syncope, Ageing, Merck & Co., Cervical intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal cancer, Virus-like particle, Observation, CIN, Thigh, Human, HPV, Plant, Vaginal intraepithelial neoplasia, Nausea, MRK, VLP, Investment, Immunity, Fever, Erythema, Vaccination, Injury, Vaccine, Allergy, Itch, AIN, Swelling

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

Key Points: 
  • Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage.
  • These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen.

Merck Completes Acquisition of Harpoon Therapeutics, Inc.

Retrieved on: 
Monday, March 11, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, MSD, Glomus tumor, Carcinoma, EPS, BCMA, Patient, Neoplasm, Merck & Co., Acquisition, Cancer, Epithelial cell adhesion molecule, DLL3, MRK, Safety, Pharmacokinetics, B-cell maturation antigen, SCLC, Food, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP).

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP).
  • Harpoon is now a wholly-owned subsidiary of Merck, and Harpoon’s common stock will no longer be publicly traded or listed on the Nasdaq Stock Market.
  • “We continue to augment and diversify our oncology pipeline with innovative approaches to help people with cancer worldwide,” said Dr. Dean Y. Li, president, Merck Research Laboratories.
  • Under the terms of the merger agreement, Merck, through a subsidiary, has acquired all outstanding shares of Harpoon.