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Merck (NYSE:MRK) has discontinued the vibostolimab and pembrolizumab coformulation arm of a late-stage skin cancer trial.
KeyVibe-010, a randomized Phase 3 trial, was testing the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and Merck’s blockbuster anti-PD-1 therapy, pembrolizumab (Keytruda), compared to Keytruda alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV).
The decision to discontinue testing follows an analysis, which showed that it was highly unlikely that the trial could achieve a statistically significant improvement in recurrence-free survival (RFS), the study’s primary endpoint.
The drugmaker is unblinding the study and recommends that patients receiving the coformulation be offered the option to be treated with Keytruda monotherapy.
“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,” Merck said.
Some of the key drugmakers that are actively working to develop anti-TIGIT antibodies include: Arcus Biosciences (RCUS), Compugen (CGEN), Roche (OTCQX:RHHBY), Gilead Sciences (GILD), BeiGene (BGNE), Agenus (AGEN), Bristol Myers Squibb (BMY), iTeos Therapeutics (ITOS).