Phase 3 divarasib KRAS G12C inhibitor vs PD-1 immunotherapy/observation after resection.

Hoffmann‑La Roche’s KRASCENDO 3 (Phase 3, randomized, open-label) tests whether divarasib—an oral, covalent KRAS G12C small‑molecule inhibitor—improves outcomes versus investigator’s choice of pembrolizumab (Merck) or nivolumab (Bristol Myers Squibb) or observation after complete resection of Stage II–IIIB KRAS G12C+ NSCLC. Eligible patients previously received neoadjuvant platinum-doublet chemotherapy plus PD‑1 immunotherapy and specifically did not achieve a pathologic complete response (pCR), a group with meaningful residual relapse risk. Participants are randomized within a defined post-surgery window and treated with divarasib daily for a long adjuvant course (up to ~3 years) versus PD‑1 therapy when appropriate based on prior treatment sequence, or observation when no further systemic therapy is planned. The scientific/commercial angle is bringing genotype-matched KRAS inhibition into the curative-intent perioperative setting rather than waiting for metastatic relapse. Today’s care after neoadjuvant chemoimmunotherapy and surgery is risk-adapted adjuvant PD‑1 therapy for some patients or observation, without an approved KRAS G12C–targeted adjuvant standard.