In its phase 3 Krascendo 1 trial, Roche revealed findings showing divarasib, a novel KRAS G12C inhibitor, outperformed existing treatments for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) that had progressed after prior therapy.
Participants treated with divarasib monotherapy lived significantly longer, lowering the risk of death by 44% compared with sotorasib or adagrasib. Median overall survival (OS) for divarasib is approximately 18 months, compared to 12 months for the control arm.
No new safety findings were observed with divarasib, and the most common treatment-related adverse events (TRAEs) were mainly low grade and manageable.
The data was presented at the 2026 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine.
The G12C mutation is one of the most common KRAS mutations, found in approximately one in eight people with NSCLC. People with NSCLC who have the KRAS G12C mutation may have poorer outcomes than those who have the unmutated KRAS gene.
According to Levi Garraway, Roche’s Chief Medical Officer, the phase 3 Krascendo 1 trial results highlight divarasib’s potential to set a new benchmark in treating patients with previously treated KRAS G12C-mutated lung cancer.
Ferdinandos Skoulidis, the study’s lead researcher, emphasized the urgent need for treatments that extend life, as most patients with this cancer type eventually experience relapse after initial treatment, with few effective options available for recurrent cases.
Roche is actively pursuing a clinical development program focused on NSCLC, exploring divarasib both as a single treatment and in combination regimens that exclude chemotherapy, across various disease stages and treatment lines. In 2022, the drug received Breakthrough Therapy Designation from the US Food and Drug Administration.
This designation has been granted to divarasib due to its potential to provide a significant improvement over existing treatments for KRAS G12C-mutated NSCLC.
The clinical development programme for divarasib is ongoing, and the company is committed to investigating its potential as a treatment for NSCLC. The results of the Krascendo 1 study are a positive step forward in this effort, and they will inform future development plans for divarasib.
