Daraxonrasib Raises Median Survival to 13.2 Months in RAS G12 Group
Key Facts
Results from the RASolute 302 trial showed median overall survival of 13.2 months among patients in the RAS G12 group who received daraxonrasib, versus 6.6 months with chemotherapy, according to the trial analysis reported by OncLive. The hazard ratio comparing the two groups was 0.40. The detailed figures come from the trial’s primary analysis, while data presented at the 2026 European Society for Medical Oncology congress were exploratory subgroup analyses. The company said a survival benefit was seen in the RAS groups evaluated, but interpretation of these analyses remains descriptive, and detailed survival figures for each group are not available here. The society noted that the small sizes of some molecular groups limit the conclusions that can be drawn.
The trial tested daraxonrasib in 500 patients at 59 centers across 6 countries, randomly assigning them in a 1:1 ratio to the drug or chemotherapy. A total of 248 patients received daraxonrasib, while the comparison group included 252 patients. Researchers selected one of four chemotherapy regimens: gemcitabine with nab-paclitaxel, modified FOLFIRINOX, liposomal irinotecan with fluorouracil and leucovorin, or FOLFOX. The comparison therefore reflects a choice among several regimens determined by the investigator, rather than one standardized chemotherapy regimen. The trial design pits the drug’s results against treatment options actually used as comparators in the study.
Across all participants, median progression-free survival was 7.2 months with daraxonrasib, versus 3.6 months with chemotherapy, according to U.S. Food and Drug Administration data. The objective response rate was 30% in the drug group, compared with 11% in the chemotherapy group. In an analysis reported by OncLive, the confirmed objective response rate was 31.6% versus 11.2%, with the published percentages differing in how the measure was described. On June 8, 2026, the European Society for Medical Oncology provided context for the comparison, saying chemotherapy options for patients with previously treated metastatic pancreatic cancer are generally associated with median overall survival of between 6 and 7 months and median progression-free survival of between 3 and 4 months. The society described the subgroup analyses as exploratory and called for them to be read descriptively, particularly where molecular groups were small.
In the United States, the Food and Drug Administration approved daraxonrasib, marketed as RASONQUE, on August 26, 2026, for adults with metastatic pancreatic adenocarcinoma who had received at least one prior systemic treatment, or for whom multi-agent systemic therapy is not appropriate. The agency said pancreatic cancer accounts for about 3.2% of all cancer diagnoses, and adenocarcinoma makes up about 90% to 95% of the 67,000 new pancreatic cancer cases each year in the United States. The agency reviewed the application through Project Orbis, in collaboration with Health Canada and with official observers from the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency. It said U.S. approval came about 6.5 months before the target review date.
In Europe, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended on October 15, 2026, that daraxonrasib be granted marketing authorization in the European Union. The committee forwarded its recommendation to the European Commission for a final decision. This follows U.S. approval, while the European process remains subject to the Commission’s decision. Revolution Medicines shares closed at $187.69 on October 22, 2026, according to EL7 data. The data do not specify the closing time relative to the company’s October 23 statement, so they do not establish that the price preceded the announcement.