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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.
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Globe Newswire broke the news on Thursday, July 2, 2026.
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