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A next-gen KRAS inhibitor just cleared a major bar. The phase 3 Krascendo 1 trial showed divarasib cut the risk of death by 44% and extended overall survival by nearly 6 months compared to sotorasib or adagrasib in previously treated KRAS G12C–mutated NSCLC. With a cleaner safety profile and longer treatment duration, experts are calling it a potential new standard of care.
The phase 3 Krascendo 1 trial delivered a landmark result: divarasib, a next-generation KRAS G12C inhibitor, significantly outperformed the two currently approved agents — sotorasib and adagrasib — in patients with previously treated, advanced KRAS G12C–mutated non-small cell lung cancer (NSCLC). Presented at the 2026 ESMO Congress and simultaneously published in The New England Journal of Medicine, the findings are being called "potentially practice changing" by leading oncologists.
Beyond superior efficacy, divarasib also showed a more favorable safety profile. Despite patients staying on divarasib more than twice as long (11.3 vs. 5.0 months), rates of serious adverse events and treatment discontinuations were lower. Gastrointestinal side effects like diarrhea and nausea were more common with divarasib, but mostly grade 1 and manageable. Hepatotoxicity and QT prolongation — concerns with older agents — were notably less frequent.
By the Numbers
Why it matters: Unlike sotorasib and adagrasib, which never demonstrated an overall survival benefit over docetaxel, divarasib is the first KRAS G12C inhibitor to show a clear OS advantage — the gold standard endpoint in oncology. With first-line combination trials (divarasib + pembrolizumab) already underway, this drug could reshape treatment across multiple lines of NSCLC care.
