Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

Bristol Myers Squibb announced that the pivotal Phase 3 KRYSTAL-12 confirmatory trial evaluating their targeted therapy KRAZATI (adagrasib) as monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer has successfully achieved its primary endpoint of progression-free survival (PFS), along with meeting key secondary endpoints such as overall response rate (ORR). The drug was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in 2022 for adults with KRASG12C-mutated NSCLC who have received at least one prior systemic therapy. The continued approval may be dependent upon further verification and description of clinical benefits in a larger patient population.