RASolute 302
Daraxonrasib versus chemotherapy of the investigator's choice in previously treated metastatic pancreatic ductal adenocarcinoma (RASolute 302)
Phase 3N = 500NCT06625320
- Population
- Previously treated metastatic pancreatic ductal adenocarcinoma (91.8% with RAS G12 mutation)
- Design
- International, open-label, randomised phase 3 trial of daraxonrasib (oral RAS(ON) multiselective inhibitor) versus investigator's-choice chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma. Dual primary endpoints: overall survival and progression-free survival in the RAS G12 population; overall-population analyses were key secondary endpoints. The control was physician's-choice chemotherapy, not a single regimen.
- Primary endpoint
- OS, PFS
- Arms
- Daraxonrasib (experimental, n = 248): Daraxonrasib orally
- Investigator's-choice chemotherapy (control, n = 252): Chemotherapy of the investigator's choice
- People
- O'Reilly EM
OSHR 0.4Δ median OS+6.6 monthsPFSHR 0.45Δ median PFS+3.8 monthsOSHR 0.4Δ median OS+6.5 months
Show the numbers
| Endpoint | Analysis | Daraxonrasib | Investigator's-choice chemotherapy | Effect |
|---|---|---|---|---|
| OSRAS G12 populationDual primary endpoint in the RAS G12 population | primaryO'Reilly 2026 | median 13.2 months | median 6.6 months | HR 0.4P<0.001The abstract gives no confidence interval for this hazard ratio. |
| PFSRAS G12 populationDual primary endpoint in the RAS G12 population | primaryO'Reilly 2026 | median 7.3 months | median 3.5 months | HR 0.45P<0.001The abstract gives no confidence interval for this hazard ratio. |
| OSOverall population (500 randomised)Key secondary endpoint in the overall population | primaryO'Reilly 2026 | median 13.2 months | median 6.7 months | HR 0.4P<0.001 |
| PFSOverall population (500 randomised)Key secondary endpoint in the overall population | primaryO'Reilly 2026 | median 7.2 months | median 3.6 months | HR 0.49P<0.001 |
| OSOverall population (500 randomised)Overall population, as reported on the FDA approval-notice page | primarySource 2026 | median 13.2 months | median 6.7 months (5.8–8.0) | HR 0.40 (95% CI 0.30–0.53)P<0.0001FDA page: 95% CI for the daraxonrasib median is 10.0 months to not estimable (an open upper bound cannot be shown here). The FDA page states that the major efficacy outcome measures were OS and PFS as assessed by blinded independent central review. |
| PFSOverall population (500 randomised)Overall population, blinded independent central review, as reported on the FDA approval-notice page | primarySource 2026 | median 7.2 months (5.7–7.5) | median 3.6 months (2.9–4.2) | HR 0.49 (95% CI 0.38–0.64)P<0.0001 |
| ORROverall population (500 randomised) | primarySource 2026 | 30% (25–36%) | 11% (7–15%) | P<0.0001 |
| Endpoint | Analysis | Daraxonrasib | Investigator's-choice chemotherapy | Effect |
|---|---|---|---|---|
| OSRAS G12 populationDual primary endpoint in the RAS G12 population | primaryO'Reilly 2026 | median 13.2 months | median 6.6 months | HR 0.4P<0.001The abstract gives no confidence interval for this hazard ratio. |
| PFSRAS G12 populationDual primary endpoint in the RAS G12 population | primaryO'Reilly 2026 | median 7.3 months | median 3.5 months | HR 0.45P<0.001The abstract gives no confidence interval for this hazard ratio. |
| OSOverall population (500 randomised)Key secondary endpoint in the overall population | primaryO'Reilly 2026 | median 13.2 months | median 6.7 months | HR 0.4P<0.001 |
| PFSOverall population (500 randomised)Key secondary endpoint in the overall population | primaryO'Reilly 2026 | median 7.2 months | median 3.6 months | HR 0.49P<0.001 |
| OSOverall population (500 randomised)Overall population, as reported on the FDA approval-notice page | primarySource 2026 | median 13.2 months | median 6.7 months (5.8–8.0) | HR 0.40 (95% CI 0.30–0.53)P<0.0001FDA page: 95% CI for the daraxonrasib median is 10.0 months to not estimable (an open upper bound cannot be shown here). The FDA page states that the major efficacy outcome measures were OS and PFS as assessed by blinded independent central review. |
| PFSOverall population (500 randomised)Overall population, blinded independent central review, as reported on the FDA approval-notice page | primarySource 2026 | median 7.2 months (5.7–7.5) | median 3.6 months (2.9–4.2) | HR 0.49 (95% CI 0.38–0.64)P<0.0001 |
| ORROverall population (500 randomised) | primarySource 2026 | 30% (25–36%) | 11% (7–15%) | P<0.0001 |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.4 | 0.3–0.53 |
| PFS | 0.49 | 0.38–0.64 |
- Daraxonrasib (experimental)
- Investigator's-choice chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Daraxonrasib | Investigator's-choice chemotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 8 | 65.7% | 43.2% |
| 17 | 41.0% | 16.8% |
| 25 | 26.9% | 7.2% |
| 33 | 17.7% | 3.1% |
- Daraxonrasib (experimental)
- Investigator's-choice chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Daraxonrasib | Investigator's-choice chemotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 5 | 62.2% | 37.1% |
| 9 | 42.5% | 16.8% |
| 14 | 26.5% | 6.3% |
| 18 | 18.1% | 2.8% |
Appears in
Sources
O'Reilly EM, Wainberg ZA, Hendifar AE, Borad MJ, Pietrantonio F, Pant S, et al. Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer. N Engl J Med. 2026;395(4):325-337.
US Food and Drug Administration. FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma (Resources for Information | Approved Drugs). Page content current as of 26 August 2026; read 21 October 2026.