Bristol Myers details Krazati confirmatory study failure in colorectal cancer

Bristol Myers discovered that confirmatory trial for Krazati in colorectal cancer failed to meet its primary endpoint, jeopardizing its accelerated approval in this indication.

Krazati received accelerated FDA approval in June 2024 for KRAS G12C-mutant metastatic colorectal cancer in combination with cetuximab, based on early-phase KRYSTAL-1 data showing an objective response rate of 34% and median progression-free survival of 6.9 months.

The confirmatory Phase 3 trial (KRYSTAL-10) was designed to upgrade accelerated approval to full approval by demonstrating an improvement in progression-free and overall survival compared to standard therapy but did not meet these goals.

Following the failure, Bristol Myers has disclosed the trial did not meet its primary endpoint without releasing full data, and the company is evaluating next steps with regulators, which may include discussion of potential withdrawal or label changes.

The failure in colorectal cancer adds pressure on Bristol Myers to demonstrate value for Krazati in other KRAS G12C settings, particularly in NSCLC where confirmatory data in lung cancer remain positive.