Divarasib - (Krascendo 1)

02 July 2026: Roche (SIX: RO, ROP; OTCQX: RHHBY) reported positive Phase III results from Krascendo 1 (NCT06497556) evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, versus first-generation KRAS G12C inhibitors sotorasib or adagrasib in adults with previously treated KRAS G12C-mutant advanced/metastatic non-small cell lung cancer. The randomized, open-label, multicenter trial (n=338) met its primary endpoint of BICR-assessed progression-free survival, with divarasib delivering clinically meaningful and statistically significant PFS improvement versus the control arm. The study also met a key secondary endpoint: overall survival, achieving statistical significance at the interim analysis. No new safety signals were observed; the most common treatment-related adverse events were described as manageable and reversible.

Roche said the Krascendo 1 data will be presented at an upcoming medical meeting and submitted to health authorities.

Ongoing Phase III program: Krascendo 2 (NCT06793215) tests divarasib + pembrolizumab vs chemotherapy + pembrolizumab in first-line KRAS G12C advanced NSCLC; Krascendo 3 (NCT07541170) evaluates adjuvant divarasib vs immunotherapy or observation after resection in stage II–IIIB KRAS G12C NSCLC.