Revolution Medicines (RVMD) Status update summary

Landmark clinical results from RASolute 302

• Phase III RASolute 302 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.

• Progression-free survival doubled to 7.3 months with daraxonrasib, and objective response rate was nearly three times higher than chemotherapy (31.6% vs. 11.2%).

• Survival benefit was consistent across subgroups, including age, sex, performance status, and mutational status.

• Daraxonrasib demonstrated a manageable safety profile, with lower rates of severe adverse events (43.6% vs. 57.5%) and rare treatment discontinuations (1.2% vs. 11.2%) compared to chemotherapy.

• Patient-reported outcomes showed significant improvements in pain and quality of life, with delayed deterioration in pain (median 9.2 vs. 3.8 months) and global health status (median 5.7 vs. 2.6 months).

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

• Most common treatment-related adverse events for daraxonrasib were rash and stomatitis; for chemotherapy, neutropenia, thrombocytopenia, fatigue, diarrhea, and neuropathy.

• No unexpected safety findings were observed with daraxonrasib.