US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed its decision to terminate the clinical development of vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody, following recent disappointing data from Phase III trials.
Discontinuation of Vibostolimab Trials
The Phase III KeyVibe-003 and KeyVibe-007 studies, which were assessing the efficacy of a fixed-dose combination of vibostolimab and pembrolizumab in certain patients with non-small cell lung cancer (NSCLC), will be discontinued. Both trials met the pre-specified futility criteria for the primary endpoint of overall survival in a pre-planned analysis. The safety profile of the combination was consistent with previous studies, with no new safety signals identified. However, the fixed-dose combination resulted in more immune-related adverse events than pembrolizumab alone, which is consistent with the expected effects of dual checkpoint inhibitor therapy.
Favezelimab Trial Enrollment Halted
For favezelimab, enrollment for the Phase III KEYFORM-008 trial will be stopped. This trial was evaluating the fixed-dose combination of favezelimab and pembrolizumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) whose disease has progressed following prior anti-PD-1 therapy. KEYFORM-008 is the only Phase III study in the KEYFORM clinical development program for which results are not yet available. The decision was made after a thorough evaluation of data from the favezelimab clinical program, and priority will be given to other candidates in MSD’s comprehensive and diversified oncology pipeline.-Fineline Info & Tech
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