Clinical trialsCompany release

Roche's divarasib beats sotorasib and adagrasib on survival in Phase III KRAS G12C lung cancer trial

Roche · Sun 25 Oct 2026

Krascendo 1 data presented at ESMO show divarasib cut the risk of death by 44% in previously treated KRAS G12C-mutated NSCLC versus the two approved inhibitors.

Roche has reported positive Phase III results for divarasib, its investigational KRAS G12C inhibitor, in previously treated patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The Krascendo 1 data were presented at the ESMO congress on 25 October 2026 and published at the same time in the New England Journal of Medicine.

The trial compared divarasib with sotorasib or adagrasib. Divarasib reduced the risk of death by 44%, with median overall survival of 17.7 months against 12.0 months for the comparator arm. It also lowered the risk of disease progression or death by 42%.

Roche said no new safety signals emerged with divarasib. The summary available does not give detailed adverse-event data, patient numbers or subgroup results, so the safety profile relative to the comparators cannot yet be assessed in detail.

The company said it is working with health authorities on next steps. Divarasib already holds Breakthrough Therapy and Orphan Drug designations from the US Food and Drug Administration. Roche has not announced filing dates or approval timelines.

What it means for your team

  • Regulatory teams should watch for Roche's filing plans with the FDA and other agencies, since existing Breakthrough Therapy designation may support more frequent agency interaction and a faster review.
  • Head-to-head overall survival data against both sotorasib and adagrasib could shape future comparative-effectiveness and HTA discussions in second-line KRAS G12C NSCLC.
  • Pharmacovigilance teams should review the full NEJM publication for adverse-event detail, as only the absence of new safety signals has been stated so far.
  • Market-access teams tracking the KRAS G12C class should note that the comparator arm used the two currently available inhibitors.

Company's press release: Roche ↗

Article written by VigiEye from the official source (Roche). Claims are the company's own. AI-assisted; check the source before acting.

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