Bristol Myers: Krazati plus cetuximab showed ORR of 34%, PFS of 6.9 months

Bristol Myers Squibb announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer. These late breaking data will be featured in an oral presentation at the 2024 American Association for Cancer Research annual meeting on Monday, April 8 at 11:10 a.m. Pacific Time and will be highlighted as part of the meeting’s official press program. The data will also be published simultaneously in Cancer Discovery. With a median follow up of 11.9 months in 94 patients, KRAZATI plus cetuximab demonstrated an objective response rate, the primary endpoint, of 34%, median progression-free survival of 6.9 months, and median overall survival of 15.9 months in pre-treated patients with KRASG12C-mutated locally advanced or metastatic CRC. The median duration of response was 5.8 months. Disease control was observed in 85% of patients. The safety profile for KRAZATI plus cetuximab was manageable and consistent with previous reports, and with the known safety profile of each drug individually. The company announced in February 2024 that the FDA had accepted a supplemental new drug application for KRAZATI in combination with cetuximab as a targeted treatment option for patients with previously treated KRASG12C-mutated locally advanced or metastatic CRC for priority review and assigned a Prescription Drug User Fee Act goal date of June 21, 2024.