BMS Details Confirmatory Trial Win for KRAS Inhibitor Krazati

1. Confirmatory Trial Success: Bristol Myers Squibb (BMS) announced that its pivotal Phase 3 KRYSTAL-12 study evaluating Krazati (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) met its primary endpoint of progression-free survival (PFS).
2. Comparison to Chemotherapy: Krazati significantly reduced the risk of tumor progression or death compared to chemotherapy in patients with KRAS G12C-mutated NSCLC.
3. Statistical Significance: The improvements in both PFS and tumor shrinkage were statistically significant and clinically meaningful.
4. Accelerated Approval: Krazati received accelerated approval for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.
5. Competitive Advantage: BMS's Krazati appears to hold more potential in the first-line setting compared to Amgen's Lumakras, which was forced to run another phase 3 study to support its approval.
6. Future Trials: BMS plans to initiate another first-line phase 3 trial combining Krazati with Keytruda and chemotherapy in patients with TPS scores below 50%, including those with PD-L1-negative tumors.
7. Colorectal Cancer Trials: BMS is also evaluating Krazati in combination with cetuximab for the treatment of patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer.