Genentech’s KRAS G12C inhibitor divarasib reported superior Phase 3 results in previously treated NSCLC patients in the Krascendo 1 trial, showing clinically meaningful and statistically significant improvements in both overall survival and progression-free survival versus approved therapies. Roche said there were no new safety signals and most treatment-related side effects were manageable and reversible. Divarasib had previously earned breakthrough therapy designation (2022) and orphan drug designation (2026) for KRAS G12C NSCLC, setting up the next step as Genentech plans to submit the data to regulators and present at an upcoming medical meeting. The data sharpen competitive pressure in a post–first-generation KRAS G12C landscape that has been shaped by acquired resistance, with Roche positioning divarasib for use after prior exposure to Lumakras (amgen) and Krazati (Bristol Myers Squibb).