Bristol Myers Squibb disclosed that the confirmatory phase 3 Krystal-10 trial of Krazati (adagrasib) plus Eli Lilly’s Erbitux (cetuximab) failed to hit statistical significance in KRAS G12C-mutated metastatic colorectal cancer. The study enrolled 461 previously treated patients and missed dual primary endpoints of progression-free survival and overall survival. Krazati’s initial U.S. accelerated approval in CRC came in combination with Erbitux in June 2024, requiring confirmatory trials to secure full approval. BMS said the phase 3 results presented at the ESMO Gastrointestinal Cancers Congress 2026 in Munich supported the clinical activity of the combination, but the company is now discussing “next steps” with regulators. BMS emphasized that lung cancer remains the larger potential market for Krazati, pointing to two first-line NSCLC pivotal trials still underway. The company’s next regulatory moves for colorectal cancer will depend on how regulators interpret the confirmatory evidence versus the accelerated approval framework. The setback raises pressure on how quickly BMS can transition accelerated oncology assets into durable, registrable benefit profiles across indications where patient populations are smaller and endpoints are harder to mature.