SOUTH SAN FRANCISCO (dpa-AFX) - Roche Holding AG (RHHBY) announced positive pivotal results from its Phase III Krascendo 1 study, showing that investigational therapy divarasib significantly outperformed currently approved KRAS G12C inhibitors in patients with previously treated KRAS G12C-mutated 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 both overall survival (OS) and progression-free survival (PFS) compared with first-generation KRAS G12C inhibitors sotorasib and adagrasib.
Patients treated with divarasib experienced a 44% reduction in the risk of death, while median overall survival reached approximately 18 months, compared with 12 months in the control arm. The investigational drug also reduced the risk of disease progression or death by 42% versus the comparator therapies.
The survival and disease-control benefits were consistent across clinically relevant patient subgroups, including those defined by PD-L1 expression levels and KEAP1 mutation status. In addition, the objective response rate (ORR) with divarasib was nearly twice that achieved with sotorasib or adagrasib.
Safety findings remained consistent with previous studies, and no new safety signals were identified. Roche said the most common treatment-related adverse events were generally low grade and manageable.
The Krascendo 1 trial is the first head-to-head Phase III study comparing a next-generation KRAS G12C inhibitor against approved first-generation therapies. The results strengthen divarasib's potential to become a new standard treatment option for patients with KRAS G12C-mutated NSCLC whose disease has progressed following prior therapy.
Roche is currently advancing a broad Phase III clinical development program evaluating divarasib both as a standalone treatment and in chemotherapy-free combinations across multiple stages and lines of NSCLC therapy. The U.S. Food and Drug Administration previously granted Breakthrough Therapy Designation to divarasib in 2022 and awarded Orphan Drug Designation for KRAS G12C-mutated NSCLC in 2026.
For More Such Health News, visit rttnews.com.
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
