In brief
- Divarasib met the primary endpoint of progression-free survival in Krascendo 1, a Phase III trial that compared it directly with sotorasib and adagrasib.
- Roche reported that the overall survival benefit reached statistical significance at an interim analysis, without releasing figures.
- No new safety signals were reported. The detailed data are to be presented at a medical meeting and submitted to health authorities.
Study at a glance
- Trial: Krascendo 1 (NCT06497556), Phase III, randomised open-label
- Population: 338 adults with previously treated, advanced or metastatic KRAS G12C-mutant NSCLC
- Comparators: sotorasib or adagrasib, the approved first-generation KRAS G12C inhibitors
- Primary endpoint: progression-free survival (met)
- Key secondary: overall survival (statistically significant at interim analysis)
The trial
Krascendo 1 (NCT06497556) enrolled 338 adults with previously treated, advanced or metastatic KRAS G12C-mutant NSCLC. Patients received once-daily divarasib or one of the approved comparators, sotorasib once daily or adagrasib twice daily. The primary endpoint was progression-free survival assessed by blinded independent central review, and overall survival was a key secondary endpoint.
Findings
Roche reported statistically significant and clinically meaningful improvements in progression-free survival with divarasib, and said the overall survival benefit reached statistical significance at an interim analysis. The company did not release specific survival figures. It reported no new safety signals, and said the most common treatment-related events were manageable and reversible.
Roche accompanied the results with a statement from its Chief Medical Officer:
“The superior survival demonstrated in this global head-to-head comparison of KRAS G12C inhibitors confirms the potential of divarasib to improve clinical outcomes for people with KRAS G12C non-small cell lung cancer.”Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche
Background
Divarasib is an oral inhibitor designed to bind KRAS G12C and hold the mutant protein in an inactive state. Sotorasib and adagrasib were the first-generation KRAS G12C inhibitors approved for NSCLC, and Krascendo 1 tested divarasib directly against them. The US Food and Drug Administration granted divarasib Breakthrough Therapy Designation in 2022 and Orphan Drug Designation for KRAS G12C NSCLC in 2026.
What comes next
Roche said the detailed Krascendo 1 data will be presented at an upcoming medical meeting and submitted to health authorities.
Sources
- Roche. Roche Reports Positive Phase 3 Results for Divarasib in Previously Treated KRAS G12C NSCLC (2026-07-05). roche.com
This article was produced independently by the Lung Summit editorial team, without industry funding or input.
