Revolution Medicines, Inc. announced on September 10, 2025, key clinical updates from its daraxonrasib Phase 1 clinical trials, providing strong evidence to support the planned initiation of RASolute 303, a global Phase 3 registrational trial in first-line (1L) metastatic pancreatic ductal adenocarcinoma (PDAC). Long-term follow-up data for daraxonrasib monotherapy in second-line (2L+) metastatic PDAC, as of a June 30, 2025 cutoff, reinforced its promising clinical activity and durability.
The company reported highly encouraging initial clinical results for daraxonrasib 300 mg QD monotherapy in treatment-naïve RAS-mutant PDAC patients, based on a July 28, 2025 data cutoff. Additionally, initial clinical results for the combination of daraxonrasib 200 mg QD plus standard dose gemcitabine nab-paclitaxel (GnP) in 1L metastatic PDAC were also highly encouraging, demonstrating a competitive safety profile.
These compelling findings support the company's plans to initiate the three-arm Phase 3 RASolute 303 trial in Q4 2025. This trial will evaluate daraxonrasib monotherapy and the daraxonrasib plus GnP combination, each compared to a control arm of GnP treatment. This strategic move aims to establish new global standards of care across treatment lines for this devastating disease, significantly expanding daraxonrasib's potential market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.