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Genentech’s Divarasib Shows Superiority in Head-to-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer
Divarasib showed statistically significant gains in progression-free and overall survival, and Roche said the safety profile remained consistent with earlier data.
On Thursday, July 2, 2026, Roche announced positive Phase III Krascendo 1 results showing divarasib significantly improved progression-free and overall survival compared to approved KRAS G12C inhibitors sotorasib and adagrasib in advanced lung cancer.
The KRAS G12C mutation locks proteins in an active state, driving continuous tumor growth. First-generation inhibitors like sotorasib and adagrasib reached the market but faced drug resistance challenges, creating demand for more potent next-generation options.
In the 338-patient study, divarasib met its primary and secondary endpoints with statistically significant survival improvements. Roche reported no new safety signals, with treatment-related side effects "manageable and reversible" throughout the trial.
Roche plans to submit data to health authorities and present findings at an upcoming medical meeting. Chief Medical Officer Levi Garraway stated the results "should establish divarasib as a new standard of care" for previously treated patients.
Beyond the current trial, Roche is evaluating divarasib in Krascendo 2 and Krascendo 3 studies for first-line and adjuvant settings. The company competes with MSD and Eli Lilly, who are also advancing next-generation KRAS inhibitors in phase 3.