Revolution Medicines’ Daraxonrasib Advances to Phase III in Pancreatic Cancer

Revolution Medicines is advancing its RAS inhibitor, daraxonrasib, into Phase III trials for pancreatic ductal adenocarcinoma (PDAC) following strong Phase I/Ib results (NCT05379985). The trial evaluated daraxonrasib across advanced solid tumours, including PDAC, NSCLC, and colorectal cancer, demonstrating an objective response rate (ORR) of 35% in patients with RAS G12X mutations and 29% in all RAS-mutant PDAC patients. Disease control rates reached over 90%, with median progression-free survival (PFS) of 8.1–8.5 months and overall survival (OS) of 13.1–15.6 months, significantly outperforming standard nab-paclitaxel/gemcitabine (GnP).

Daraxonrasib also showed promise in first-line settings, with ORR of 47% as monotherapy and 55% in combination with GnP. Safety remained favourable, with fewer than 10% of patients experiencing severe treatment-related adverse events. Revolution is now enrolling patients for Phase III RASolute 302 and planning RASolute 303 to explore daraxonrasib as both monotherapy and combination therapy, aiming to reshape PDAC treatment outcomes.

16-09-2025