Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), on Thursday reported positive Phase III results from the Krascendo 1 trial evaluating investigational KRAS G12C inhibitor divarasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC).

The study met its primary and key secondary endpoints, with divarasib demonstrating statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared with approved KRAS G12C inhibitors sotorasib or adagrasib, while no new safety signals were observed.

Genentech said the safety profile was consistent with previous data, with the most common treatment-related adverse events described as manageable and reversible. The company noted that KRAS G12C mutations occur in approximately 14% of NSCLC cases and are associated with poor prognosis.

The data will be presented at an upcoming medical meeting and submitted to health authorities.

Genentech is advancing a comprehensive Phase III clinical development programme for divarasib in NSCLC, both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration previously granted divarasib Breakthrough Therapy Designation in 2022 and Orphan Drug Designation for KRAS G12C NSCLC in 2026.