Vibostolimab coformulated with pembrolizumab versus pembrolizumab alone as adjuvant therapy for high-risk stage IIB-IV melanoma (KEYVIBE-010): a randomised, double-blind, phase 3 study - PubMed
6 days ago
- #immunotherapy
- #melanoma
- #clinical trial
- The study evaluated vibostolimab coformulated with pembrolizumab versus pembrolizumab alone as adjuvant therapy for high-risk stage IIB-IV melanoma.
- A total of 1402 participants were randomly assigned to receive either the coformulated treatment or pembrolizumab alone.
- At the first interim analysis, the median study follow-up was 4.2 months, with no significant difference in recurrence-free survival between the two groups.
- The hazard ratio for recurrence-free survival was 1.25 (95% CI 0.9-1.8), indicating no additional clinical benefit from the coformulated treatment.
- Common grade 3 or higher treatment-related adverse events included adrenal insufficiency, hepatitis, rash, maculopapular rash, and pruritus.
- Treatment-related serious adverse events occurred in 11% of the coformulated group and 4% of the pembrolizumab alone group.
- The study was discontinued based on prespecified futility criteria, concluding that pembrolizumab monotherapy remains the standard of care for resected high-risk melanoma.