Revolution Medicines Inc（RVMD）のニュースとイベントRVMDRevolution Medicines Inc

Revolution Medicines' RASONQUE Receives Positive Opinion from EU

Revolution Medicines announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion of RASONQUE once-daily oral tablets as a monotherapy indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. If approved by the European Commission, RASONQUE would provide the first broad RAS-targeted treatment option in the European Union for adults with metastatic pancreatic adenocarcinoma.

Propanc Biopharma Plans to Start PRP Clinical Trial in 2027

Propanc Biopharma (PPCB) highlighted new preclinical data for its candidate PRP in pancreatic ductal adenocarcinoma and compared that profile with a clinical standard recently established by Revolution Medicines (RVMD). On August 26, the FDA approved daraxonrasib, Revolution Medicines' oral RAS multi-selective inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy. Approval was based on the Phase 3 RASolute 302 trial. In the RAS G12 population, daraxonrasib delivered median overall survival of 13.2 months versus 6.6 months with chemotherapy, median progression-free survival of 7.3 months versus 3.5 months, and a confirmed objective response rate of 33.2% versus 11.8%. Results in the intent-to-treat population were consistent: median overall survival 13.2 versus 6.7 months and median progression-free survival 7.2 versus 3.6 months. Those data validate RAS as a druggable driver in a disease in which RAS mutations are present in roughly 90% of cases. They also leave a defined residual problem: epithelial-mesenchymal transition, cancer stem cells, fibrosis, and metastatic dissemination are not the primary targets of RAS pathway blockade. PRP is a proprietary intravenous fixed-ratio combination of the pancreatic proenzymes, trypsinogen and chymotrypsinogen. It does not inhibit RAS. In orthotopic and patient-derived xenograft models of advanced PDAC, three-times-weekly intravenous PRP produced: greater than 90%, mean, tumor growth inhibition, versus vehicle, building on previously reported inhibition above 85%. A marked reduction in metastatic burden in the liver and peritoneum. Remodeling of the tumor microenvironment, including lower cancer-associated fibroblast activity, less fibrosis, and suppression of EMT markers. Greater sensitivity of chemo-resistant PDAC cells to gemcitabine plus nab-paclitaxel, supporting the potential for lower chemotherapy doses with improved activity. A median overall survival extension of more than 2.5-fold versus controls. Limited prior compassionate-use experience with related proenzyme formulations has shown signals of prolonged survival in advanced solid-tumor patients, with a favorable safety profile and no severe treatment-related adverse events reported in that experience. PRP holds FDA Orphan Drug Designation Status for the treatment of pancreatic cancer and is not restricted to the RAS genotype. The Company plans to start a multicenter, open-label Phase 1b first-in-human study of PRP in the first quarter of 2027. The study is expected to enroll up to 50 patients with advanced solid tumors, including pancreatic, ovarian, and refractory prostate cancers, at sites across Australia.

Revolution Medicines Launches RASolute 309 Clinical Trial

Revolution Medicines announced that it has begun treating patients in RASolute 309, a global, randomized Phase 3 clinical trial evaluating the combination of Rasonque, a RAS(ON) multi-selective inhibitor, and zoldonrasib, an investigational RAS(ON) G12D-selective inhibitor, as a first-line treatment in adult patients with metastatic RAS G12D pancreatic adenocarcinoma.