Rasonque subtype results raise a caveat, but analysts stay bullish

FDA review documents show Rasonque (daraxonrasib), Revolution Medicines’ newly approved pancreatic cancer drug, had different response rates across KRAS mutation subtypes in the Phase 3 RASolute 302 trial.

The overall objective response rate was 33%. It was 50% in patients with KRAS G12V, 24% in the larger G12D subgroup, and 7% in the smaller G12R subgroup—below the chemotherapy control group for G12R.

Analysts remained broadly positive. Leerink said it was premature to assume Rasonque would lose its position in G12D disease, pointing to survival results and the company’s broader development program. Truist called the subtype split a ‘small crack’ in the data, noting the exploratory analyses were not powered for comparisons between mutations.

Rasonque is already approved in the U.S. for certain adults with metastatic pancreatic adenocarcinoma after prior systemic therapy, and analysts see it as a second-line standard-of-care option with limited near-term competition in the RAS/KRAS space.

The subtype findings warrant attention, but they do not by themselves overturn the drug’s broader evidence:
in the Phase 3 trial, median overall survival was 13.2 months with Rasonque versus 6.7 months with chemotherapy.