Revolution’s daraxonrasib heads to Phase III after strong PDAC trial results

Revolution Medicines is advancing its RAS inhibitor daraxonrasib into two Phase III trials for pancreatic ductal adenocarcinoma (PDAC), following encouraging Phase I/Ib data showing strong response rates, survival benefits, and a favorable safety profile.

Why it matters: PDAC remains one of the deadliest cancers, with fewer than 7% of patients surviving five years. Current treatments like nab-paclitaxel/gemcitabine (GnP) offer limited benefit. A targeted therapy like daraxonrasib could reshape the treatment landscape and extend survival for patients with RAS-driven tumors.

Backstory: In the Phase I/Ib trial, daraxonrasib achieved a 35% objective response rate (ORR) in patients with RAS G12X mutations and nearly doubled median overall survival (13–15.6 months) compared with standard GnP chemotherapy (7.4 months). Disease control rates reached over 90%, with manageable safety concerns (no new safety signals and <10% severe adverse events). First-line data showed even higher responses: 47% ORR as monotherapy and 55% in combination with GnP.

Big picture: The move into Phase III positions Revolution alongside a wave of biotechs racing to improve PDAC outcomes. Seven drugs are in late-stage development, including Akeso’s PD-1/VEGF bispecific ivonescimab, projected to reach $8.9B in sales in 2031. Analysts expect daraxonrasib to hit blockbuster status by 2029, with $2.1B in revenue forecast by 2031.