Merck has terminated a clinical trial arm combining vibostolimab and pembrolizumab for treating resected high-risk melanoma. The decision was made after an analysis revealed a higher discontinuation rate for the coformulation arm due to immune-related events, diminishing the likelihood of a significant improvement in the primary endpoint of recurrence-free survival (RFS). The independent Data Monitoring Committee recommended unblinding the study and offering patients receiving coformulation monotherapy with pembrolizumab.

Despite this setback, Merck remains committed to developing novel treatments for melanoma, particularly in earlier stages. The company’s oncology pipeline includes the ongoing Phase 3 V940-001 trial investigating V940 (mRNA-4157), an individualized neoantigen therapy, in combination with pembrolizumab as adjuvant treatment for high-risk melanoma.

Vibostolimab, Merck’s investigational anti-TIGIT antibody, aims to boost antitumor activity by blocking the TIGIT receptor and activating T lymphocytes. Merck’s clinical development program for the vibostolimab and pembrolizumab coformulation encompasses over 3,000 patients.

Phase 3 studies of the co-formulation in lung cancer are ongoing, including KeyVibe-003, KeyVibe-006, KeyVibe-007, and KeyVibe-008. External data monitoring committees routinely monitor these studies, and interim safety reviews have not raised significant concerns.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.