Divarasib results announced by Roche on October 25, 2026, showed that its experimental lung cancer treatment extended median overall survival to 17.7 months, compared with 12.0 months for sotorasib or adagrasib. The phase III Krascendo 1 findings strengthen the evidence behind Roche’s oncology pipeline, but divarasib remains investigational.
Key Takeaways
- Median overall survival improved by 5.7 months in previously treated KRAS G12C-mutated lung cancer.
- The trial also showed longer progression-free survival, with no new safety signals reported.
- Roche is working with health authorities and testing divarasib in additional treatment settings.
Table of Contents
- Divarasib results establish a head-to-head survival benefit
- Safety findings support the efficacy data
- Regulatory work and broader trials remain ahead
- Conclusion
Divarasib results establish a head-to-head survival benefit
Roche’s phase III Krascendo 1 announcement described a randomized, open-label study involving 338 adults with previously treated advanced or metastatic non-small cell lung cancer carrying the KRAS G12C mutation. Participants received either divarasib alone or one of two existing KRAS G12C inhibitors, sotorasib or adagrasib.
At the primary analysis, divarasib reduced the risk of death by 44% relative to the control arm. The overall survival hazard ratio was 0.56, with a 95% confidence interval of 0.41–0.78 and a p-value of 0.0005. The 5.7-month difference in median survival describes the trial groups, not a guaranteed benefit for each patient.
Median progression-free survival—the time before disease progression or death—was 9.8 months with divarasib versus 5.7 months with the comparator treatments. The study met its primary and key secondary endpoints, Roche said.
The findings were presented at the 2026 European Society for Medical Oncology Congress and simultaneously published in The New England Journal of Medicine.
| Item | Details |
|---|---|
| Confirmed objective response rate | 58% with divarasib versus 32% with control treatment. |
| Median duration of response | 11.9 months versus 6.9 months among responders. |
| Treatment-related discontinuations | 4.8% versus 11.7%. |
| Serious treatment-related adverse events | 7.8% versus 15.2%. |
Safety findings support the efficacy data
Roche reported no new safety signals. The most common treatment-related adverse events included gastrointestinal problems, such as diarrhea, nausea and vomiting, along with liver toxicity. The company described most treatment-related events as low grade and manageable.
Treatment-related discontinuations and serious treatment-related adverse events were less frequent with divarasib, even though patients remained on treatment longer: 11.3 months compared with 5.0 months in the control arm.
The response findings also favored divarasib. Response-rate calculations excluded ten participants who did not have measurable disease at baseline, while response duration was assessed only among patients who responded.
Regulatory work and broader trials remain ahead
The direct comparison with existing targeted medicines makes the results an important development for Roche’s lung cancer portfolio. However, positive phase III findings do not themselves constitute regulatory approval or establish future sales.
Roche Chief Medical Officer Levi Garraway said the company was working closely with health authorities to bring the treatment to patients. The announcement did not provide an approval timetable.
Roche’s broader phase III program includes Krascendo 2, testing divarasib with pembrolizumab in previously untreated advanced disease, and Krascendo 3, evaluating divarasib after surgery and standard treatment in earlier-stage disease. Those studies address different patient populations from Krascendo 1.
Conclusion
Divarasib results provide evidence of longer survival against existing KRAS G12C inhibitors in previously treated lung cancer. Roche’s work with health authorities and its ongoing phase III studies are the next developments to watch; the company has not announced an approval timetable.
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