Roche’s divarasib has achieved superior results in a head-to-head Phase 3 trial against existing KRAS G12C inhibitors for non-small cell lung cancer (NSCLC), according to data released by the company. The drug, which targets the KRAS G12C mutation found in about 13% of NSCLC patients, demonstrated a statistically significant improvement in progression-free survival compared to Amgen’s Lumakras and Bristol Myers Squibb’s Krazati. This sets a new benchmark in a competitive therapeutic space that has seen rapid evolution since Lumakras became the first approved KRAS inhibitor in 2021.
The multicenter trial enrolled over 500 patients with previously treated KRAS G12C-mutant advanced NSCLC. Divarasib showed a median progression-free survival of 11.5 months versus 6.8 months for the control arm, with a 52% reduction in the risk of disease progression or death. The safety profile was also favorable, with grade 3 or higher treatment-related adverse events occurring in 18% of divarasib patients compared to 32% in the control group, though details on specific toxicities were not disclosed.
Divarasib is currently under regulatory review by the FDA with a Prescription Drug User Fee Act (PDUFA) date set for the fourth quarter of 2026. An approval would position Roche to enter a market currently dominated by Amgen and BMS, which have been competing for second-line treatment share. A European Medicines Agency filing is expected later this year.
Roche’s stock rose 3.2% on the news, adding roughly $8 billion to its market valuation, as analysts project peak annual sales of $2–3 billion for divarasib if approved. The successful trial also validates Roche’s broader oncology strategy, which includes a pipeline of next-generation RAS pathway inhibitors. However, the KRAS field is crowded: other contenders like Mirati’s adagrasib (now under BMS) and emerging agents from Merck and Johnson & Johnson are in late-stage development.
Some oncologists caution that while the data are compelling, divarasib’s benefit over existing options may be modest for certain patient subgroups, and cost considerations will factor into adoption. The head-to-head superiority does not guarantee first-line use, and KRAS resistance mechanisms remain a clinical challenge that will require combination strategies.