Revolution Medicines (RVMD) Status update 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 overall), 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, with sequential international filings planned and an expanded access program operational in the U.S.

• Plans for robust commercialization infrastructure and expansion of commercial and operational capabilities are in place to support global launch upon approval.

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

Study design and patient population

• RASolute 302 enrolled adults with metastatic pancreatic adenocarcinoma who had one prior chemotherapy regimen.

• Patients were randomized 1:1 to daraxonrasib or investigator's choice of chemotherapy.

• Dual primary endpoints were overall survival and progression-free survival in the RAS G12 population.

• Key secondary endpoints included OS and PFS in the overall population, objective response rate, and patient-reported outcomes.

Safety and tolerability

• Daraxonrasib had a manageable safety profile with no unexpected findings, and grade ≥3 treatment-related adverse events occurred in 43.6% of daraxonrasib patients vs 57.5% for chemotherapy.

• Most common treatment-related adverse events were rash and stomatitis 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%).

• Prophylactic measures for rash and stomatitis are being implemented, with physician education and standardized management protocols planned to optimize tolerability.