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Genentech’s Divarasib Demonstrated Best-in-Class Efficacy, Advancing the Standard of Care in Previously Treated KRAS G12C-mutated Lung Cancer

Business Wire

  • Divarasib monotherapy demonstrated superior efficacy over first-generation KRAS G12C inhibitors, lowering the risk of disease progression or death by 42% and the overall risk of death by 44%, in the Phase III Krascendo 1 study

  • At the time of primary analysis, divarasib achieved a median overall survival of approximately 18 months, compared to 12 months for sotorasib or adagrasib

  • No new safety signals were observed with divarasib; the most common treatment-related adverse events were mainly low grade and manageable

  • Data presented as a late-breaking abstract during a Presidential Symposium at the 2026 ESMO Congress and simultaneously published in The New England Journal of Medicine

SOUTH SAN FRANCISCO, Calif., October 25, 2026--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today pivotal results from the Phase III Krascendo 1 study, which demonstrated the superior efficacy of investigational divarasib, a next-generation KRAS G12C inhibitor, compared with current standard of care KRAS G12C inhibitors in people with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC). Participants treated with divarasib monotherapy lived significantly longer, lowering the risk of death by 44% compared with sotorasib or adagrasib (overall survival, OS, HR 0.56, [95% CI: 0.41-0.78], p=0.0005). Median OS for divarasib is currently approximately 18 months, compared to 12 months for the control arm (see table below). No new safety findings were observed with divarasib and the most common treatment-related adverse events (TRAEs) were mainly low grade and manageable. These data were presented as a late-breaking abstract during a Presidential Symposium at the 2026 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine.

"The Phase III Krascendo 1 results demonstrate the potential for divarasib to become a new standard of care for people with previously treated KRAS G12C-mutated lung cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "The superior efficacy against the current standard of care demonstrated in this head-to-head trial reinforces divarasib's best-in-class profile. We are working closely with health authorities to bring this new treatment option to the people who need it."

The G12C mutation is one of the most common KRAS mutations, found in approximately one in eight people with NSCLC. Accumulating evidence suggests that people with NSCLC who have the KRAS G12C mutation may have poorer outcomes than those who have the unmutated KRAS gene (wild-type disease). Despite the approval of current, first-generation KRAS G12C-targeted treatments, there remains a significant unmet need for more effective therapy options.

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