Bristol Myers Squibb announced that its cancer drug Krazati failed to meet primary efficacy endpoints in the Phase 3 KRYSTAL-10 confirmatory trial. The study evaluated Krazati in combination with cetuximab for patients with a specific type of metastatic colorectal cancer. Data presented at the 2026 ESMO Gastrointestinal Cancers congress showed the regimen did not significantly improve survival compared to standard chemotherapy.
Patients treated with the Krazati combination recorded a median progression-free survival of 7.5 months. The standard chemotherapy group achieved a median progression-free survival of 8.1 months. Median overall survival for the Krazati group reached 21.6 months. The chemotherapy group saw a median overall survival of 21.7 months. The Krazati regimen produced a numerically higher overall response rate despite failing the primary endpoints.
The lack of statistical significance on primary endpoints puts Krazati’s accelerated approval for this indication at risk. Bristol Myers Squibb is currently discussing the trial results and future path with the FDA.