Revolution Medicines announces results from daraxonrasib Phase 1 trials

Revolution Medicines (RVMD) on Wednesday announced clinical updates from its daraxonrasib Phase 1 clinical trials. The data focuses on new daraxonrasib data in patients with metastatic pancreatic ductal adenocarcinoma, including long-term follow-up data in second line patients and initial monotherapy and chemotherapy-combination data in first line patients. As of a June 30, 2025 cutoff date, patients with second line and beyond metastatic PDAC treated with daraxonrasib 300 mg daily were evaluated for long-term follow-up on key safety and efficacy endpoints. In 2L+ patients with RAS mutant PDAC, daraxonrasib 300 mg QD was generally well tolerated with a safety profile consistent with previously reported data. No new safety signals were identified. Daraxonrasib at 300 mg QD demonstrated compelling antitumor activity and durability, with the following results for patients with second line RAS mutant PDAC with a RAS G12X mutation or any RAS mutation, respectively: The confirmed objective response rate per RECIST v1.1 was 35% and 29%. The disease control rate was 92% and 95%. The median progression-free survival was 8.5 months and 8.1 months. The median overall survival was 13.1 and 15.6 months. RASolute 302, the ongoing Phase 3 registrational trial of daraxonrasib monotherapy as a 2L treatment for metastatic PDAC, remains on track to complete global enrollment this year to enable an expected data readout in 2026. As of a July 28, 2025 cutoff date, patients with treatment-naive RAS-mutant PDAC treated with daraxonrasib 300 mg QD monotherapy were evaluated on key safety and antitumor activity endpoints. In patients treated in this cohort, the safety profile observed for daraxonrasib monotherapy as a first line treatment was generally consistent with the reported safety findings for daraxonrasib in the 2L setting. The mean dose intensity was 85%. In patients who met the definition of 1L metastatic PDAC and had sufficient follow-up, the ORR was 47% and the DCR was 89%, with a median follow-up of 9.3 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit. The combination of daraxonrasib plus chemotherapy is designed to sustain continuous suppression of RAS signaling by maintaining sufficient dose intensity for daraxonrasib, to leverage the antitumor contribution of chemotherapy and to achieve a safety profile that is competitive against standard chemotherapy. In patients with RAS mutations, daraxonrasib plus GnP was generally well tolerated. The safety profile observed for the combination regimen was consistent with the sum of the known safety findings of each respective agent, and no new safety signals emerged. The mean dose intensity was 81%. In patients who had sufficient follow-up, the ORR was 55% and the DCR was 90%, with a median follow-up of 6.9 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit.