Roche divarasib beats approved KRAS G12C inhibitors in first head-to-head Phase 3 lung cancer trial
People with previously treated KRAS G12C lung cancer may have a stronger option ahead. Roche $RHHBY says its next-generation inhibitor divarasib beat both approved drugs, Amgen's $AMGN sotorasib and Bristol Myers' $BMY adagrasib, on progression-free and overall survival in the fi
Roche $RHHBY has reported positive results from its Phase 3 Krascendo 1 study, and the design is what makes it notable: rather than testing its investigational drug against a placebo, Roche ran its next-generation KRAS G12C inhibitor divarasib directly against the two treatments already on the market, Amgen's $AMGN sotorasib and Bristol Myers Squibb's $BMY adagrasib. In patients with previously treated KRAS G12C non-small cell lung cancer, divarasib produced statistically significant improvements in both progression-free survival and overall survival, with the survival benefit reaching significance at an interim analysis and no new safety signals observed. Roche describes it as the first global head-to-head Phase 3 comparison of KRAS G12C inhibitors in lung cancer. For patients and oncologists, a head-to-head win is a higher bar than a placebo comparison, because it answers the question that actually matters at the bedside: not whether a drug works, but whether it works better than what is already prescribed. Roche has not yet released median survival numbers, hazard ratios or response rates, and plans to present the full data at a medical meeting and file with regulators. Per Roche.