Bristol Myers Squibb disclosed that its confirmatory phase 3 Krystal-10 trial of Krazati (adagrasib) plus cetuximab failed to meet dual primary endpoints in previously treated KRAS G12C-mutated metastatic colorectal cancer. The company detailed the results after the miss and said it is discussing next steps with regulatory authorities. The study enrolled 461 patients and did not achieve statistical significance on progression-free survival and overall survival. BMS framed its position around continued clinical activity observed in the broader dataset and stressed that Krazati’s larger market opportunity remains in lung cancer, where additional pivotal trials are underway. Under the accelerated approval framework, confirmatory study failures can delay or alter the path to full approval, increasing scrutiny on registrational strategies and label scope.