Roche has announced positive results from the phase 3 Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against the approved, first generation KRAS G12C inhibitors sotorasib or adagrasib in patients with previously treated KRAS G12C Non-Small Cell Lung Cancer (NSCLC). The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both Progression-Free Survival (PFS) and Overall Survival (OS). The safety profile for divarasib remained consistent with previous data, with no new findings detected and the most common treatment-related events being manageable and reversible.

Levi Garraway, MD, PhD, Chief Medical Officer (CMO) and Head—Global Product Development, Roche, said, “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. These results should establish divarasib as a new Standard of Care for previously-treated lung cancer patients with this genetically defined tumor subtype.”

Efficacious treatments for KRAS G12C NSCLC represent a significant unmet need in lung cancer care. The G12C mutation is one of the most common KRAS oncogene mutations, found in approximately 14 percent of NSCLC cases and associated with poor prognosis for patients.

Roche is advancing a comprehensive phase 3 clinical development program in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to divarasib in 2022, and in 2026, Orphan Drug Designation (ODD) for KRAS G12C NSCLC.

Data from the Krascendo 1 study will be presented at an upcoming medical meeting and submitted to health authorities with the aim of bringing this potential treatment option to people with KRAS G12C NSCLC as soon as possible.