Roche: Divarasib lifts median survival to 17.7 months in lung trial
Key Facts
Results from the Phase 3 Krascendo 1 trial showed median overall survival of 17.7 months among patients who received divarasib, compared with 12 months in the control group, according to Fierce Biotech, citing data presented at the 2026 European Society for Medical Oncology meeting. The study compared the experimental drug with two first-generation treatments targeting the KRAS G12C mutation, sotorasib and adagrasib. Roche said in July that the trial met its primary endpoint, showing statistically significant improvements in overall survival and progression-free survival. The result puts divarasib in direct comparison with the two treatments in a specific group of patients with advanced non-small cell lung cancer. The drug remains investigational, while the company said it would submit the data to health authorities.
The open-label, multicenter, randomized study included 338 adults with advanced non-small cell lung cancer carrying a KRAS G12C mutation, all of whom had received previous treatment. Median progression-free survival was 9.8 months with divarasib, compared with 5.7 months with the control treatment, according to Fierce Biotech. This measure tracks how long patients live without their disease worsening, while overall survival measures the time until death from any cause. The difference in both measures provides a dual readout of the trial results, after Roche said both improved statistically. The data concern previously treated patients and therefore remain tied to the participants' characteristics and the study's conditions.
The objective response rate was 58% among patients who received divarasib, compared with 32% in the control group, according to figures Fierce Biotech reported from the Krascendo 1 results. The rate refers to the proportion of patients whose tumors shrank under the trial's criteria. The control group included patients who received one of two options: sotorasib, taken once daily, or adagrasib, taken twice daily. The study therefore did not test drugs from particular companies in general, but compared divarasib with two specific KRAS G12C inhibitors. Roche's chief medical officer said the survival advantage in the global head-to-head comparison underscored the potential to improve clinical outcomes for this group of patients.
Krascendo 1 excluded patients who had previously received a KRAS G12C inhibitor or a pan-KRAS/RAS inhibitor, according to Fierce Biotech. This condition limits the scope of the comparison, as the study was restricted to previously treated patients who had not received those classes of inhibitors. The control treatment included sotorasib or adagrasib, rather than a broad range of treatments or drugs from the two companies that developed them. In July, Roche announced that the study had met its primary and key secondary endpoints, with statistically significant improvements in progression-free survival and overall survival. The company said at the time that the data would be presented at a later medical meeting, and Fierce Biotech subsequently reported the detailed comparison results presented at the 2026 meeting.
Roche is also advancing Krascendo 2, which is testing divarasib with pembrolizumab as a first-line treatment, compared with pembrolizumab plus chemotherapy. The study targets previously untreated patients with advanced or metastatic lung cancer carrying a KRAS G12C mutation, according to Roche's description. This study represents a different research path from Krascendo 1, which enrolled previously treated patients and compared divarasib with two first-generation inhibitors. The current data concern the results of a specific trial, while Roche said it would submit them to health authorities; no specific timing was provided in the available information. Roche shares, listed under the symbol RHHBY, closed at $61.17 on Oct. 23, 2026, according to EL7 data.