Roche gets a lung cancer win with its KRAS drug divarasib
A Phase 3 comparison reported longer survival with the investigational KRAS inhibitor than with older inhibitors.
TL;DR
- Roche reported Phase 3 results for divarasib in previously treated KRAS G12C-mutated non-small cell lung cancer.
- Median overall survival was 17.7 months with divarasib versus 12.0 months with sotorasib or adagrasib.
- The open-label study had limitations, including a relatively small adagrasib control group.
Roche and researchers reported results from Krascendo 1, a Phase 3 trial comparing investigational divarasib with sotorasib or adagrasib in previously treated advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. The trial enrolled 338 patients. [1] [2] [3] [4]
Median overall survival was 17.7 months for divarasib and 12.0 months for the combined control group. Median progression-free survival was 9.8 months versus 5.7 months, according to Roche and MD Anderson. [2] [3] [4]
MD Anderson said severe treatment-related side effects occurred in 25% of the divarasib group and 35% of the control group. Roche said the results were presented at ESMO and published in NEJM. [2] [3]
MD Anderson identified the open-label design and a relatively small number of patients receiving adagrasib as limitations; people with untreated brain metastases were excluded. Roche said it is working with health authorities on the investigational treatment. [2] [3]
Why it matters
A direct comparison with existing KRAS G12C inhibitors gives regulators and developers evidence about a potential new entrant in the lung-cancer treatment market, subject to the study’s limitations and regulatory review.
Editor's note
carried over from the 2026-10-28 pool; not previously published. Roche sponsored the study and MD Anderson led it; the cited sources describe the same trial, not an independent replication. NEJM is The New England Journal of Medicine.