Roche’s divarasib, a KRAS G12C inhibitor, produced superior outcomes in a Phase 3 head-to-head study (Krascendo 1) versus approved therapies in previously treated non-small-cell lung cancer (NSCLC) patients. Roche said the interim analysis showed clinically meaningful and statistically significant improvements in overall survival and progression-free survival over Amgen’s Lumakras (sotorasib) and Bristol Myers Squibb’s Krazati (adagrasib), without new safety signals. Roche expects to submit the data to regulators and present details at an upcoming medical meeting, positioning divarasib as a potential new second-line standard for KRAS G12C–driven NSCLC. The FDA granted breakthrough therapy designation in 2022 and orphan drug designation in 2026 for this indication. The result adds pressure to the KRAS G12C competitive set as sponsors work to translate potency and selectivity into durable survival benefits across lines of therapy.