At the ESMO Congress on October 25, 2026, Roche announced late-stage clinical trial results for its experimental drug divarasib in treating KRAS G12C-mutated non-small cell lung cancer. In the 338-patient Krascendo 1 study, divarasib cut the risk of death by 44% and extended median overall survival to nearly 18 months, outperforming current therapies sotorasib and adagrasib while demonstrating lower treatment discontinuation rates due to adverse side effects.
Efficacy results from the Krascendo 1 trial
- ▪The objective response rate in the Phase III Krascendo 1 trial was 58% for patients taking divarasib, compared with 32% for those taking sotorasib or adagrasib
- ▪In the Phase III Krascendo 1 trial, patients receiving divarasib achieved a median overall survival of nearly 18 months, compared with 12 months for those treated with sotorasib or adagrasib
- ▪In the Phase III Krascendo 1 trial involving 338 patients with previously treated KRAS G12C-mutated non-small cell lung cancer, Roche's divarasib reduced the risk of death by 44% compared to approved KRAS G12C inhibitors sotorasib and adagrasib
- ▪Divarasib lowered the risk of disease progression or death by 42%, showing a median progression-free survival of 9.8 months compared with 5.7 months for the control group treated with sotorasib or adagrasib
Phase III Krascendo 1 trial presentation and design
- ▪The Phase III Krascendo 1 trial directly tested Roche's divarasib against Amgen Inc.'s sotorasib and Bristol-Myers Squibb Co.'s adagrasib, rather than comparing it against chemotherapy
- ▪Results from Roche's Phase III Krascendo 1 trial evaluating divarasib were presented on October 25, 2026, at the European Society for Medical Oncology Congress in Madrid and published in the New England Journal of Medicine
Safety profile and adverse events
- ▪Researchers in the Phase III Krascendo 1 trial reported no new safety findings for divarasib, noting its safety profile was consistent with previous reports for divarasib and other KRAS inhibitors
- ▪In the Phase III Krascendo 1 trial, approximately 4.8% of patients receiving divarasib discontinued treatment due to treatment-related adverse events, compared with 11.7% in the control group treated with sotorasib or adagrasib
Expert and executive reactions
- ▪Thoracic oncologist Jia Luo from the Dana-Farber Cancer Institute stated that divarasib will replace existing established KRAS G12C inhibitors for treating KRAS G12C-mutated lung cancer
- ▪Roche Deputy Chief Medical Officer Stefan Frings stated that the Phase III Krascendo 1 trial produced practice-changing data
Future trials and commercial outlook
- ▪Roche announced it is working with health authorities to bring divarasib to patients following the Phase III Krascendo 1 trial results
- ▪According to Bloomberg-surveyed analysts, sales for Roche's divarasib could reach just over 1 billion Swiss francs ($1.3 billion) in 2032
- ▪Roche is conducting clinical trials pairing divarasib with Merck & Co.'s Keytruda for newly diagnosed patients and testing divarasib post-surgery to prevent lung cancer recurrence
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