Roche's experimental lung cancer drug beat two rivals in a pivotal trial

Median overall survival was 17.7 months with divarasib, versus 12.0 months in the control arm, the company said. Divarasib also cut the likelihood of disease progression or death by 42%, and patients on it went a median of 9.8 months without progression, compared with 5.7 months for those on the control drugs. The confirmed objective response rate reached 58% with divarasib, compared with 32% among patients given the control drugs.

The randomized, open-label Krascendo 1 study enrolled 338 adults. Of those, 167 received divarasib once daily and 171 received either sotorasib once daily or adagrasib twice daily. The primary endpoint was progression-free survival assessed by blinded independent central review. Roche said the study met its primary and key secondary endpoints.

The results were published in The New England Journal of Medicine and also presented as a late-breaking abstract during the European Society for Medical Oncology Congress.

Roche said no new safety findings emerged. The most common treatment-related adverse events were gastrointestinal toxicity and liver toxicity. Fewer patients stopped divarasib because of treatment-related adverse events (4.8% versus 11.7%), and serious events occurred in 7.8% of divarasib patients versus 15.2% of those on the control drugs.

"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," Levi Garraway, Roche's chief medical officer and head of global product development, said in a statement. He said the company is collaborating with regulators to make the treatment available to patients.

Sotorasib is made by Amgen $AMGN and adagrasib by Bristol Myers Squibb $BMY, according to The Wall Street Journal. Roche Deputy Chief Medical Officer Stefan Frings told The Wall Street Journal, “The data are practice-changing.” Roche lifted its forecast for the drug’s yearly peak revenue last month to a range of 2 billion to 3 billion Swiss francs, from a prior range of 1 billion to 2 billion francs, according to The Wall Street Journal.

The U.S. Food and Drug Administration granted divarasib Breakthrough Therapy Designation in 2022 and Orphan Drug Designation for KRAS G12C-mutated non-small cell lung cancer in 2026, Roche said. The company is running two other phase III studies of divarasib, one in first-line advanced disease combined with pembrolizumab and one in early-stage resected disease.