Noticias y eventos de Revolution Medicines Inc (RVMD)RVMDRevolution Medicines Inc

Revolution Medicines Reports RASONQUE Clinical Trial Data

Revolution Medicines "announced that The New England Journal of Medicine has published a report describing data from the Phase 1/2 clinical trial evaluating RASONQUE (daraxonrasib), an oral, RAS(ON) multi-selective inhibitor, in patients with previously treated advanced RAS mutant non-small cell lung cancer, NSCLC. The results published in NEJM are based on the Phase 1/2 RMC-6236-001 trial, with a July 21, 2025 data cut off. The trial evaluated the safety and efficacy of once-daily doses of RASONQUE 300 mg or less in 136 patients with second-line or later NSCLC with tumors carrying diverse RAS mutations other than RAS G12C, and whose disease had progressed following, or who were intolerant to, platinum-based chemotherapy and anti-PD-(L)1 therapy. RASONQUE demonstrated dose-dependent antitumor activity and exhibited a manageable safety profile in the Phase 1/2 trial. Within the 160 mg to 220 mg dose group, a subgroup of 38 docetaxel-naive patients had previously received first- or second-line platinum-based chemotherapy and anti-PD-(L)1 therapy. In this subgroup, the confirmed objective response rate was 42% (95% confidence interval [CI], 26%-59%) and a disease control rate of 89% (95% CI, 75%-97%). The median progression-free survival was 8.3 months (95% CI: 4.0-12.5) and median overall survival was 16.0 months (95% CI, 9.5-not estimable). At these dose levels, Grade 3 treatment-related adverse events (TRAEs) occurred in 25% of patients, most commonly rash (8%) and diarrhea (3%). No Grade 4 or Grade 5 TRAEs were reported within this dose range." "The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial evaluating RASONQUE in previously treated RAS mutant non-small lung cancer. Together with the recent FDA approval of RASONQUE in metastatic pancreatic cancer, the data reported in the NEJM publication provide additional clinical validation of our broad RAS(ON) multi-selective and mutant-selective approach across major RAS-driven cancers," said Alan Sandler, M.D., chief development officer of Revolution Medicines.

Revolution Medicines' Rasonque Approved by FDA, Priced at $39,800

Revolution Medicines disclosed that following FDA approval of Rasonque for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy, once-daily oral tablets are now available in the United States for physicians to prescribe to eligible patients. The wholesale acquisition cost of Rasonque is $39,800 for a 30-day supply, based on the recommended daily dose.

Revolution Medicines' RASONQUE Approved by FDA for Metastatic Pancreatic Cancer

Revolution Medicines announced that the U.S. Food and Drug Administration has approved RASONQUE once-daily oral tablets, for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE represents the first targeted cancer medicine to be approved from a groundbreaking new class of RAS(ON) multi-selective and mutant-selective inhibitors. The FDA approval of RASONQUE is based on data from RASolute 302, a global, randomized Phase 3 trial evaluating RASONQUE versus investigator's choice of cytotoxic chemotherapy in patients with previously treated metastatic PDAC. The trial met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat population, which included patients with or without an identified tumor RAS mutation.