Merck & Co Inc

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• Merck Halts Drug Combination Arm of Study Testing Potential Melanoma Treatment, from 10 hours ago by MT Newswires

  10 hours ago by MT Newswires
  Companies Mentioned: MRK
  07:58 AM EDT, 05/13/2024 (MT Newswires) -- Merc (MRK) said Monday it halted the vibostolimab and pembrolizumab combination arm of its phase 3 trial evaluating investigational adjuvant treatments for patients with resected high-risk melanoma. Data s...

• DJ Merck Ends Co-Formulation Arm of Keytruda High-Risk Melanoma Study, from 10 hours ago by Dow Jones

  10 hours ago by Dow Jones
  Companies Mentioned: MRK
  
  By Colin Kellaher
  
  Merck & Co. has ended part of a late-stage study of a co-formulation of its blockbuster cancer drug Keytruda in certain skin-cancer patients because the study was likely to fail.
  

• Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab as Adjuvant Treatment for Patients With Resected High-Risk Melanoma, from 11 hours ago by Business Wire

  11 hours ago by Business Wire
  Companies Mentioned: MRK

  Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA(R)), Merck's anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV). At a pre-planned analysis, data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria. A higher rate of discontinuation of all adjuvant therapy by patients in the coformulation arm versus the KEYTRUDA-only arm, primarily due to immune-mediated adverse experiences, rendered it highly unlikely that the trial could achieve a statistically significant improvement in RFS. Based on the recommendation of an independent Data Monitoring Committee (DMC), Merck is unblinding the study and recommends that patients receiving the vibostolimab and pembrolizumab coformulation be offered the option to be treated with KEYTRUDA monotherapy. Data analysis from this study is ongoing. Results will be shared with the scientific community and communicated to regulatory agencies.

• Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab as Adjuvant Treatment for Patients With Resected High-Risk Melanoma, from 11 hours ago by Dow Jones

  11 hours ago by Dow Jones
  Companies Mentioned: MRK
  RAHWAY, N.J.--(BUSINESS WIRE)--May 13, 2024--
  Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA(R) ), Merck's anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV). At a pre-planned analysis, data showed that the primary endpoint of recurrence-free survival (RFS) met the pre-specified futility criteria. A higher rate of discontinuation of all adjuvant therapy by patients in the coformulation arm versus the KEYTRUDA-only arm, primarily due to immune-mediated adverse experiences, rendered it highly unlikely that the trial could achieve a statistically significant improvement in RFS. Based on the recommendation of an independent Data Monitoring Committee (DMC), Merck is unblinding the study and recommends that patients receiving the vibostolimab and pembrolizumab coformulation be offered the option to be treated with KEYTRUDA monotherapy. Data analysis from this study is ongoing. Results will be shared with the scientific community and communicated to regulatory agencies.