Revolution beats expectations

Revolution Medicines has just toplined the phase 3 Rasolute-302 trial in second-line pancreatic cancer, but it’s already calling the results transformative. The study of the pan-RAS inhibitor daraxonrasib met its co-primary endpoints of progression-free and overall survival in RAS G12-mutant patients, the company said, as well as hitting “all key” secondary endpoints, which included PFS and OS in all comers. However, Revolution is only disclosing OS data in all comers, where daraxonrasib produced a median of 13.2 months, versus 6.7 months with chemotherapy (hazard ratio 0.40; p<0.0001). It seems unlikely that the result would be worse in G12 mutants, although full data will be keenly awaited; Revolution is aiming for ASCO. Daraxonrasib looks to have exceeded expectations: before the readout, Evercore ISI’s Cory Kasimov gave 10-11 months as the OS bar to hit. One potential remaining issue could be toxicity, with rash previously looking problematic. However, this seems unlikely to hold back use in a disease as deadly as pancreatic cancer. The company plans to submit the data to the FDA – the project has a commissioner's national priority voucher, designed to speed approval times. Revolution closed up 41%, giving it a $27bn market cap.

Phase 3 trials of daraxonrasib

Note: *excluding G12C mutant disease. Source: OncologyPipeline & clinicaltrials.gov.