Roche said its KRAS G12C inhibitor divarasib beat Amgen’s Lumakras and Bristol Myers Squibb’s Krazati in a Phase 3 head-to-head study, providing a second, confirmatory push toward standard-of-care positioning in previously treated KRAS G12C NSCLC. In the Krascendo-1 trial, Roche reported significant improvements in both overall survival and progression-free survival, while stating there were no new safety concerns and most side effects were manageable and reversible. Roche did not provide detailed efficacy figures in the initial update, directing readers to an upcoming medical meeting for specifics. The competitive context matters: Amgen first won the class with sotorasib in 2021, and BMS followed with adagrasib. Roche’s update arrives as it tries to carve out share in a mutation-driven segment where resistance mechanisms have complicated long-term outcomes. Analysts cited in the report characterized the Phase 3 win as a meaningful but not definitive step until data expand into broader settings, including ongoing work in earlier-line disease.
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