Genentech and Roche said its KRAS G12C inhibitor divarasib delivered statistically significant improvements in overall survival and progression-free survival versus approved therapies in previously treated NSCLC patients in the Phase 3 Krascendo-1 trial. The company reported the findings after an interim analysis and said there were no new safety signals, with treatment-related side effects “manageable and reversible.” The study compared divarasib against Amgen’s Lumakras and Bristol Myers Squibb’s Krazati in patients with KRAS G12C–driven NSCLC after prior therapy. Roche also highlighted that it expects to submit the data to regulators and share full details at an upcoming medical meeting. Regulatory context adds pressure on the head-to-head result: the FDA previously granted divarasib breakthrough therapy designation in 2022, and orphan drug designation in 2026, reflecting the company’s intent to secure an expanded role in the KRAS G12C market.