Roche's Divarasib Beats Rival KRAS Drugs, Cuts Death Risk 44%

Roche's experimental lung cancer drug divarasib helped patients live longer than two drugs already on the market, according to full phase 3 results the company released on Oct. 25, 2026. The Krascendo 1 trial compared divarasib with Amgen's Lumakras (sotorasib) and Bristol Myers Squibb's Krazati (adagrasib) in people with KRAS G12C-mutated non-small cell lung cancer whose disease had been treated before.

What happened

The open-label trial enrolled 338 patients. Of these, 167 received divarasib and 171 received sotorasib or adagrasib, Roche said. OncLive reported that 156 patients in the control group took sotorasib and 15 took adagrasib.

• Survival: at a first interim analysis, median overall survival was 17.7 months with divarasib and 12.0 months in the control group. Roche said this was a 44% reduction in the risk of death.
• Progression: median progression-free survival, the main goal, was 9.8 months versus 5.7 months, a 42% lower risk of progression or death.
• Response: 58% of patients responded to divarasib, compared with 32% in the control group. Responses lasted a median of 11.9 months versus 6.9 months.
• Safety: serious treatment-related side effects occurred in 7.8% of divarasib patients and 15.2% of control patients. Stopping treatment because of side effects was 4.8% versus 11.7%.

Stomach and gut side effects were more common with divarasib. OncLive reported diarrhea in 66% of divarasib patients versus 38%, nausea in 53% versus 20%, and vomiting in 39% versus 8%. Roche said these effects were mostly low grade.

The data were presented as a late-breaking abstract at the ESMO Congress in Madrid and published in the New England Journal of Medicine. Roche had said in July that the trial met its main and key secondary goals, according to Fierce Biotech.

Why it matters

The trial tested divarasib directly against both rival drugs. The lead author, Ferdinandos Skoulidis of MD Anderson, said divarasib is the first KRAS inhibitor to clearly improve survival against current options in this setting, according to Roche.

The result puts pressure on Amgen and Bristol Myers Squibb. Fierce Biotech reported that Lumakras earned $111 million for Amgen and Krazati earned $55 million for Bristol Myers Squibb in the second quarter of 2026.

Roche expects peak divarasib sales of 1 to 2 billion Swiss francs, a Roche executive told Fierce Biotech. The FDA gave divarasib Breakthrough Therapy Designation in 2022.

What it means for people in the industry

Roche has not given a date for a regulatory filing. Its deputy chief medical officer declined to share a timeline with Fierce Biotech. The company said it is working closely with health authorities.

Roche is also testing divarasib earlier in treatment. Krascendo 2 tests divarasib with pembrolizumab against chemotherapy with pembrolizumab in untreated patients. Krascendo 3 tests divarasib after surgery. People working in oncology development, medical affairs and market access should watch for a filing and for those results.

This article is news, not medical advice.

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Sources

• Roche's divarasib demonstrated best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer, Roche press release (via StockTitan)
• Divarasib Improves Survival and Paves Way for New SOC in Pretreated KRAS G12C‑Mutated NSCLC, OncLive
• ESMO: Roche touts 'convincing' phase 3 KRAS data after win over rivals, Fierce Biotech