Revolution Medicines (RVMD) Study result summary

Landmark clinical results and regulatory progress

• RASolute 302 phase III trial showed daraxonrasib reduced risk of death by 60% vs. chemotherapy in metastatic pancreatic cancer, with median overall survival of 13.2 months vs. 6.6–6.7 months for chemotherapy, marking unprecedented outcomes in this setting.

• Progression-free survival was doubled with daraxonrasib (7.3 vs 3.5 months in RAS G12; 7.2 vs 3.6 months in ITT), and objective response rate was nearly tripled compared to chemotherapy, with a manageable safety profile and improved patient-reported outcomes.

• Regulatory submissions are underway, including a rolling NDA to the FDA under Breakthrough Therapy Designation, and an expanded access program is operational in the U.S. with high demand.

• Plans for sequential international filings and a robust commercialization infrastructure are in place to support global launch upon approval.

• Daraxonrasib significantly delayed time to deterioration in pain (median 9.2 vs 3.8 months; HR 0.51) and global health status/quality of life (median 5.7 vs 2.6 months; HR 0.60) compared to chemotherapy.

Study design and patient population

• RASolute 302 enrolled 500 adults with metastatic pancreatic adenocarcinoma who had one prior chemotherapy regimen, randomized 1:1 to daraxonrasib or investigator's choice of chemotherapy.

• Patients included those with a broad range of RAS variants, including RAS G12 mutations and wild-type RAS.

• Dual primary endpoints were overall survival (OS) and progression-free survival (PFS) in the RAS G12 population; secondary endpoints included OS and PFS in the overall population, objective response rate, and patient-reported outcomes.

• Subgroup analyses showed consistent benefit across age, sex, performance status, and mutational status.

Safety and tolerability

• Daraxonrasib had a manageable safety profile with no unexpected findings and fewer grade ≥3 treatment-related adverse events (43.6%) compared to chemotherapy (57.5%).

• Most common treatment-related adverse events were rash (14%) and stomatitis (12%) for daraxonrasib, and neutropenia, thrombocytopenia, fatigue, diarrhea, and neuropathy for chemotherapy.

• Treatment discontinuation due to adverse events was lower with daraxonrasib (1.2%) than chemotherapy (11.2%).