Roche looks earlier with divarasib

Roche has already taken its KRAS G12C contender divarasib into pivotal trials in second and first-line G12C-mutated NSCLC, and at its pharma day on Monday it disclosed plans for a new phase 3 study in the adjuvant setting. According to OncologyPipeline, the only other G12C developer in late-stage trials here is Lilly, whose Sunray-02 study of olomorasib includes two parts, the first dedicated to resectable disease. In this setting olomorasib is being combined with Keytruda, and it could soon become clear whether Roche will take a similar approach with divarasib. In second-line NSCLC Roche hopes to prove that divarasib is differentiated, pitting its contender against a choice of Amgen’s Lumakras or Bristol Myers Squibb’s Krazati in the Krascendo-1 trial; results are expected next year, the company said on Monday. However, that trial’s primary completion date on clinicaltrials.gov was recently pushed back, from September 2026 to September 2027. Meanwhile a first-line Keytruda combo study, Krascendo-2, looks to have been delayed: its start date on ct.gov was previously given as May 2025, but is now December 2025. In an area as crowded as G12C, speed could be important.

Phase 3 trials of KRAS G12C inhibitors in adjuvant KRAS G12Cm NSCLC

Note: *also includes part B in unresectable stage III pts (Imfinzi combo). Source: OncologyPipeline & company presentation.