Daraxonrasib pancreatic cancer data have now reached the point of a European regulatory recommendation. On 15 October 2026, Revolution Medicines said EMA’s human-medicines committee (CHMP) had adopted a positive opinion for Rasonque (daraxonrasib) in adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The recommendation rests on the Phase 3 RASolute 302 trial. This report concentrates on the trial: how it was designed, what the drug does, what the endpoints showed, and where the evidence is weaker than the headline.
The European Commission has still to issue the final decision. Nothing here suggests a cure; the story is about months of extra survival in a disease with few options.
Daraxonrasib pancreatic cancer: key takeaways
- Design: global, open-label, randomised Phase 3 trial (NCT06625320) of daraxonrasib versus investigator’s choice of chemotherapy, in previously treated metastatic disease.
- Size: 500 patients, according to reports of the publication, randomised 1:1.
- Main overall survival: 13.2 versus 6.7 months (hazard ratio 0.40). An ad hoc analysis gave 12.4 versus 6.7 months (hazard ratio 0.49).
- Progression-free survival: 7.2 versus 3.6 months (hazard ratio 0.49).
- Cost: frequent rash, diarrhoea and mouth sores, and rare but serious events.
How daraxonrasib pancreatic cancer treatment works
Daraxonrasib is an oral RAS(ON) multi-selective inhibitor. RAS proteins act as switches that tell cells to grow, and in pancreatic cancer they are overactive in a large majority of cases. Coverage of the published trial says RAS mutations are found in more than 90% of pancreatic ductal adenocarcinomas. The company describes the drug as a noncovalent tri-complex inhibitor; reports add that it binds cyclophilin A and, together, they block the active form of RAS from engaging its partners, including G12, G13 and Q61 variants. That breadth is what separates it from older inhibitors that target a single mutation.
The design of the daraxonrasib pancreatic cancer trial
RASolute 302 enrolled adults with metastatic pancreatic cancer who had received one earlier regimen in the metastatic setting and were fit enough for treatment. According to reports of the publication, 248 patients received daraxonrasib at 300 mg once a day and 252 received a chemotherapy regimen chosen by their doctor, namely gemcitabine with nab-paclitaxel, modified FOLFIRINOX, liposomal irinotecan with fluorouracil and leucovorin, or FOLFOX. Patients were stratified by performance status, metastatic disease at diagnosis, liver metastases and RAS mutation status. The dual primary endpoints were overall survival and progression-free survival in patients with a RAS G12 mutation.
Results: survival and progression in daraxonrasib pancreatic cancer
The company reports that the trial met all primary and key secondary endpoints in both the RAS G12 group and the overall population. In the overall population, median overall survival was 13.2 months (95% confidence interval 10.0 to not estimable) with daraxonrasib versus 6.7 months (5.8 to 8.0) with chemotherapy, a hazard ratio of 0.40 (0.30 to 0.53; p below 0.0001). Median progression-free survival was 7.2 months (5.7 to 7.5) versus 3.6 months (2.9 to 4.2), hazard ratio 0.49 (0.38 to 0.64).
The 12.4 months versus 6.7 months comparison is an ad hoc analysis with a hazard ratio of 0.49 (0.39 to 0.62). The company labels it as an analysis in the RAS G12 group, while a report on the publication describes it as an overall-population analysis; we have not been able to reconcile the two. It is not the prespecified result, and it is lower than the main figure, so we treat 13.2 months as the headline and 12.4 months as supportive.
Response, quality of life and subgroups in daraxonrasib pancreatic cancer
Reports of the published trial give a confirmed objective response rate of 31.6% with daraxonrasib versus 11.2% with chemotherapy, and a 12-month survival of 53.2% versus 17.3%. They also report that time to pain deterioration was 9.2 versus 3.8 months, and time to deterioration in global health status was 5.7 versus 2.6 months. The survival benefit was reported to hold in patients with RAS G13 or Q61 mutations and in those with no identified RAS mutation, though the numbers in those subgroups are small. These figures come from trial coverage, not from the company release.
Safety in the daraxonrasib pancreatic cancer trial
The company lists diarrhoea (63.1%), acneiform dermatitis (62.4%), stomatitis (55.5%), nausea (50.8%), vomiting (41.6%) and fatigue (33.2%) as the most common adverse reactions. In the US label, 86% had dermatologic toxicity (10% grade 3), 30% had serious adverse reactions and 2.9% stopped for adverse reactions. Warnings cover gastrointestinal perforation, lung inflammation and harm to the unborn baby. Reports of the trial say discontinuation for treatment-related events was far lower than with chemotherapy, and that severe neutropenia was much less frequent, consistent with a different side-effect profile rather than a gentler one.
What the daraxonrasib pancreatic cancer evidence cannot yet tell us
Open-label design can influence endpoints that depend on a doctor’s or patient’s judgement, though overall survival is less vulnerable. The control arm combined several regimens. The trial studied patients after one prior line of treatment, so it says nothing directly about first-line use, which a separate RASolute 303 trial is testing with and without chemotherapy. Cleveland Clinic oncologist Dr Alok Khorana has cautioned that the drug is “not a magic bullet” and “not a cure,” and has pointed to early signs of resistance. For earlier-stage work in the same disease, see our report on a European trial in pancreatic cancer.
Risks and caveats for daraxonrasib pancreatic cancer
- The recommendation is not an authorisation. The Commission’s decision is pending.
- Two overall-survival figures exist, and sources differ on the population for the lower one.
- Several trial details here come from reports of the publication, not the paper itself.
- Resistance and long-term safety need longer follow-up.
In our assessment, the data show a clear and sizeable survival gain over chemotherapy in previously treated disease, with a manageable but heavy side-effect burden. Browse more pharmaceutical coverage on this site.
What to watch next for daraxonrasib pancreatic cancer
- The European Commission’s authorisation decision.
- RASolute 303 data in first-line disease.
- Longer follow-up and any resistance data.
Questions about daraxonrasib pancreatic cancer
What is daraxonrasib?
An oral RAS(ON) inhibitor from Revolution Medicines, sold as Rasonque.
How many patients were in RASolute 302?
500, randomised about 1:1 to daraxonrasib or chemotherapy, according to reports of the publication.
What were the survival results?
13.2 versus 6.7 months in the main analysis, and 12.4 versus 6.7 months in an ad hoc analysis.
Is it approved in the EU?
Not yet. The CHMP has recommended it; the European Commission decides.
How we reported this: we relied on Revolution Medicines’ announcement of 15 October 2026 and on reports of the trial publication, which we could not read directly. Figures from the reports are labelled. Last updated: 16 October 2026. This article is news reporting and not medical advice.
