KRAS-mutated lung cancer: New pill cuts risk of death by 44 percent in trial
In a Phase III trial, Roche's divarasib extended median survival to 17.7 months, compared with 12 months on existing targeted drugs. The medicine has not yet been approved.
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A new targeted drug for a specific form of non-small cell lung cancer clearly outperformed existing treatments in a large clinical trial, drugmaker Roche said on Oct. 25. Divarasib is intended for previously treated patients whose tumors carry the KRAS G12C mutation. Results of the Krascendo 1 trial were presented at the European Society for Medical Oncology (ESMO) congress and published simultaneously in the New England Journal of Medicine.
The trial enrolled 338 adults. Of these, 167 received divarasib once daily and the rest received the already approved drugs sotorasib or adagrasib. According to Roche, median overall survival was 17.7 months with divarasib and 12 months in the comparison group, equivalent to a 44% lower risk of death (hazard ratio 0.56). Progression-free survival was 9.8 months versus 5.7 months. Tumors shrank in 58% of patients, compared with 32% in the comparison group.
The most common side effects were gastrointestinal problems such as diarrhea, nausea and vomiting, as well as liver toxicity, mostly mild. Side effects led 4.8% of patients on divarasib to stop treatment, compared with 11.7% in the comparison group. The drug has not yet been approved. Roche said it is working with health authorities but gave no timeline. Patients should discuss treatment options with their oncologist.
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