Roche's Divarasib Cuts Death Risk 44% Versus Older KRAS Drugs in Phase III Trial

Roche said its investigational divarasib cut the risk of death by 44% compared with sotorasib or adagrasib in previously treated KRAS G12C-mutated non-small cell lung cancer. The phase III Krascendo 1 results were presented at the 2026 ESMO Congress and published in The New England Journal of Medicine, Stock Titan reported on October 25, 2026.

Roche's Krascendo 1 Head-to-Head Results

Krascendo 1 is the only global head-to-head study to evaluate a next-generation KRAS G12C inhibitor against approved first-generation KRAS G12C inhibitors. The trial enrolled 338 adults, with 167 randomized to divarasib once daily and 171 to sotorasib once daily or adagrasib twice daily. Median overall survival was 17.7 months for divarasib versus 12.0 months for the control arm, and median progression-free survival was 9.8 months versus 5.7 months. Divarasib reduced the risk of disease progression or death by 42%.

"The phase III Krascendo 1 results demonstrate the potential for divarasib to become a new standard of care for people with previously treated KRAS G12C-mutated lung cancer," said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. "The superior efficacy against the current standard of care demonstrated in this head-to-head trial reinforces divarasib's best-in-class profile."

Divarasib was discovered and developed by researchers within Roche and Genentech, Roche's wholly owned US subsidiary. Genentech received FDA approval for Enspryng (satralizumab) to treat adults with thyroid eye disease on October 16, 2026, following Phase III SatraGO data and priority review, TradingView reported.

Roche's Divarasib Safety and Response Data

Serious treatment-related adverse events occurred in 7.8% of divarasib patients versus 15.2% with sotorasib or adagrasib, despite divarasib patients remaining on treatment for 11.3 months compared with 5.0 months. Treatment discontinuation due to adverse events was 4.8% for divarasib versus 11.7% for the control arm. Confirmed objective response rate was 58% for divarasib versus 32% for the control arm, and median duration of response was 11.9 months versus 6.9 months.

Roche's Recent Deal Activity

According to akta.pro company records, Roche signed a global collaboration with Nurix Therapeutics on June 8, 2026, to co-develop and co-commercialize bexobrutideg (NX-5948), an oral BTK degrader for B-cell malignancies and autoimmune indications, with $700 million upfront and up to $2.3 billion in milestones. Roche also confirmed in June 2026 that it will not pull its previously announced €600 million investment for a diagnostic production site in Penzberg, Germany.

Roche's Path to Regulatory Filing

Roche said it is working closely with health authorities to bring divarasib to patients. The FDA granted Breakthrough Therapy Designation to divarasib in 2022 and Orphan Drug Designation for KRAS G12C-mutated NSCLC in 2026. Roche is advancing a phase III programme investigating divarasib as a monotherapy and as a chemotherapy-free combination across different disease settings and lines of therapy.