Roche disclosed detailed results from the Phase III Krascendo 1 trial, involving 338 patients with previously treated KRAS G12C-mutated advanced non-small-cell lung cancer.
Divarasib achieved median overall survival of 17.7 months versus 12.0 months with sotorasib or adagrasib, corresponding to a hazard ratio of 0.56 (95% CI: 0.41–0.78; p=0.0005).
Median progression-free survival was 9.8 versus 5.7 months (HR 0.58), while objective response rates were 58% versus 32%; treatment-related discontinuations occurred in 4.8% versus 11.7% of patients.
The results were presented at ESMO 2026 and simultaneously published in the New England Journal of Medicine. The trial's positive topline findings had already been announced in July; the numerical efficacy and safety details are the new information. Roche
Primary source: Roche — October 25 Phase III results
Why it matters strategically
The importance of this trial extends beyond demonstrating activity against a validated oncogenic target.
Divarasib was evaluated directly against approved drugs targeting the same KRAS G12C mutation.
This provides a different level of competitive evidence from single-arm studies or trials using chemotherapy comparators.
The reported overall survival advantage could materially change the competitive positioning of first-generation KRAS G12C inhibitors.
However, the consequences depend on regulatory approval, treatment sequencing, reimbursement, and the ability of competitors to demonstrate additional value through combination strategies.
