Roche’s Divarasib Cut Death Risk 44% in Lung Cancer Trial
A Phase III trial found Roche Group’s investigational drug divarasib extended median overall survival for patients with previously treated KRAS G12C-mutated…
Roche targets emerging oncology with divarasib, an investigational lung cancer drug that cut the risk of death by 44% in a Phase III trial. The study compared it with two approved treatments in patients with previously treated KRAS G12C-mutated non-small cell lung cancer.
The results, presented at the 2026 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine, showed median overall survival of 17.7 months with divarasib, against 12.0 months for sotorasib or adagrasib. The drug has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.
Roche targets emerging oncology with a head-to-head study
The global Krascendo 1 trial evaluated divarasib against the first-generation KRAS G12C inhibitors sotorasib and adagrasib. Genentech, a member of the Roche Group, sponsored the study. The source described it as the first and only global head-to-head study of a next-generation KRAS G12C inhibitor against approved first-generation inhibitors.
The trial included 338 adults with previously treated, locally advanced or metastatic disease. Researchers found that patients receiving divarasib had a 42% lower risk of disease progression or death, as well as the 44% lower risk of overall death, compared with patients receiving the other therapies. The study also reported longer progression-free survival and nearly twice the objective response rate.
Wade Iams, a medical oncologist and researcher at Tennessee Oncology’s Greco-Hainsworth Centers for Research, served as a principal investigator. Tennessee Oncology researchers took part in the global trial. The practice said its community-based clinical trial program gives patients access to lung cancer research near where they receive care.
“Clinical research is not something that should be conducted only at major academic medical centers,” Dr. Iams said. He said community practices can bring research treatments to patients and enroll a broader, more representative patient population. That, he added, can strengthen the science and help researchers understand how treatments work in real-world settings, while reducing the need for patients to travel long distances to join a study.
Why the results matter for patients
KRAS is among the most frequently mutated genes in lung cancer. The G12C mutation occurs in approximately 14% of patients with NSCLC, according to the source. First-generation inhibitors marked progress for this group, but patients whose disease advances after treatment continue to face limited options.
Divarasib is designed to bind more selectively to the KRAS G12C protein. The survival findings therefore address a direct clinical question: whether targeting this mutation with a next-generation inhibitor can help patients live longer after earlier treatment. The study authors said the results have potential to change practice, but the drug remains investigational and the findings do not amount to regulatory approval.
For patients and clinicians, the comparison with existing therapies gives the trial practical relevance: it tested divarasib against approved options rather than relying only on comparisons with historical outcomes. The reported survival difference and lower risk of progression offer evidence for further evaluation, while treatment decisions remain tied to available approved therapies.
The findings were presented at the 2026 ESMO Congress. Divarasib’s regulatory status remains unchanged: it has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.
Source: finance.yahoo.com
