Merck has announced the termination of the KeyVibe-008 Phase 3 trial evaluating the combination of vibostolimab and pembrolizumab in first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The decision followed a recommendation from an independent Data Monitoring Committee.
Analysis revealed that the primary endpoint of overall survival did not meet the pre-specified criteria for efficacy. Additionally, patients receiving the vibostolimab and pembrolizumab combination experienced higher rates of adverse events and immune-related adverse events compared to the control group.
Merck emphasized that this decision does not diminish its commitment to researching innovative ES-SCLC treatments, which have a low five-year survival rate and limited treatment advancements.
The company’s ongoing clinical development program in lung cancer includes multiple studies, focusing on earlier stages of disease and novel combinations. In SCLC, Merck and Daiichi Sankyo have initiated the IDeate-Lung02 Phase 3 trial evaluating ifinatamab deruxtecan (I-DXd) in relapsed patients. They have also expanded their collaboration to include the evaluation of MK-6070, a DLL3-targeting T-cell engager, in combination with I-DXd for certain patients with SCLC.
Meanwhile, other Phase 3 trials evaluating the vibostolimab and pembrolizumab combination in lung cancer, including KeyVibe-003, KeyVibe-006, and KeyVibe-007, are ongoing under routine safety monitoring by external data monitoring committees. To date, no study modifications have been recommended based on interim safety reviews.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
