Genentech announced positive results from its Phase III Krascendo 1 study today. The landmark trial evaluated divarasib directly against approved, first-generation KRAS G12C inhibitors. Specifically, researchers tested the investigational drug against sotorasib and adagrasib. The study focused entirely on patients with previously treated advanced non-small cell lung cancer.
The clinical trial successfully met its primary and key secondary endpoints. Crucially, divarasib achieved statistically significant improvements in progression-free survival. The therapy also demonstrated meaningful improvements in overall survival metrics during the interim analysis. Furthermore, the overall safety profile remained consistent with previous medical data. Doctors observed no new safety signals during the evaluation period. They noted that the most common treatment-related events remained entirely manageable.
“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,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “These results should establish divarasib as a new standard of care for previously-treated lung cancer patients with this genetically defined tumor subtype.”
Addressing Critical Unmet Needs in Oncology
Efficacious treatments for this specific cancer subtype represent a massive unmet need in modern oncology. The G12C mutation remains one of the most common genetic alterations. In fact, it appears in approximately 14% of non-small cell lung cancer cases. Historically, this specific mutation has been tightly associated with poor clinical prognoses for patients.
Consequently, Genentech is rapidly advancing a comprehensive Phase III clinical development program. The company investigates divarasib as a standalone monotherapy. Additionally, they test it as a chemotherapy-free combination across various lines of therapy. The U.S. Food and Drug Administration previously granted Breakthrough Therapy Designation to divarasib. Later, the regulatory agency awarded it Orphan Drug Designation in 2026.
The research team will present the Krascendo 1 data at an upcoming medical meeting. They also plan to submit these results to global health authorities quickly. This strategic move aims to bring the preferred KRAS G12C inhibitors to patients as soon as possible.
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News Source: Businesswire.com
