01—Abstract
Summary
Summary of the 8-K filed April 13, 2026. Cited figures are marked; the original filing is the authoritative source.
On April 13, 2026, Revolution Medicines, Inc. disclosed topline results from its global, randomized, controlled Phase 3 RASolute 302 trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
Daraxonrasib, taken orally once daily, showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with intravenous standard-of-care cytotoxic chemotherapy. In the overall (intent-to-treat) population, median OS was 13.2 months for daraxonrasib versus 6.7 months for chemotherapy, with a hazard ratio of 0.40 (p < 0.0001). The company described the drug as generally well tolerated with a manageable safety profile and no new safety signals.
Based on this first interim analysis, all PFS and OS endpoint results are considered final. The company intends to submit the data to global regulatory authorities, including the U.S. Food and Drug Administration as part of a future New Drug Application under a Commissioner's National Priority Voucher.
02—Key points
Key Highlights
- Phase 3 RASolute 302 trial met its PFS and OS endpoints in previously treated metastatic PDAC, with statistically significant and clinically meaningful improvements versus chemotherapy.
- Intent-to-treat median overall survival of 13.2 months for daraxonrasib versus 6.7 months for chemotherapy.
- Hazard ratio for overall survival of 0.40 (p < 0.0001).
- Daraxonrasib is an oral, once-daily therapy compared with intravenous cytotoxic chemotherapy.
- Company reports the drug was generally well tolerated, with a manageable safety profile and no new safety signals.
- PFS and OS endpoint results are considered final based on the first interim analysis.
- Company intends to submit the data to global regulators, including the FDA in a future New Drug Application under a Commissioner's National Priority Voucher.
03—Questions
Frequently Asked Questions
What did the Phase 3 RASolute 302 trial show?
The trial showed statistically significant and clinically meaningful improvements in both progression-free survival and overall survival for daraxonrasib compared with standard-of-care intravenous cytotoxic chemotherapy in previously treated metastatic PDAC patients.
How large was the overall survival benefit?
In the overall intent-to-treat population, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy, with a hazard ratio of 0.40 (p < 0.0001).
What was the safety profile of daraxonrasib?
The company stated that daraxonrasib was generally well tolerated, with a manageable safety profile and no new safety signals.
What are the next regulatory steps?
The company intends to submit the data to global regulatory authorities, including the FDA as part of a future New Drug Application under a Commissioner's National Priority Voucher.
Are the endpoint results final?
Based on the results of this first interim analysis, the company considers all PFS and OS endpoint results to be final.
04—Continue