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unverified 17 Jun, 10:10

Daraxonrasib nearly doubles pancreatic cancer survival in Phase 3 RASolute 302, median 13.2 months vs 6.7 on chemo

Patients with previously treated metastatic pancreatic cancer can now expect median survival of 13.2 months on Revolution Medicines $RVMD daraxonrasib versus 6.7 on chemotherapy. The Phase 3 RASolute 302 trial cut death risk 60 percent across 500 patients. Results published in NE

Patients with previously treated metastatic pancreatic cancer have a new option that nearly doubles median survival compared to chemotherapy. Revolution Medicines $RVMD presented Phase 3 results for daraxonrasib at the American Society of Clinical Oncology annual meeting in Chicago this weekend, with simultaneous publication in the New England Journal of Medicine. The RASolute 302 trial enrolled 500 patients across 59 sites in six countries. All had received one prior fluoropyrimidine- or gemcitabine-based regimen, the current first-line standard for pancreatic cancer. 459 of 500 carried RAS G12 mutations, the most common driver in this disease and the trial's primary endpoint population. Patients on daraxonrasib reached a median overall survival of 13.2 months, against 6.7 months on investigator's choice of chemotherapy. Median progression-free survival came in at 7.3 months versus 3.5. Tumor response rate was 33.2 percent versus 11.8 percent. The relative risk of death fell 60 percent. Safety favored the new drug as well. Only 1.2 percent of daraxonrasib patients discontinued treatment because of side effects, compared to 11.2 percent on chemotherapy. The most common adverse events were rash, mouth inflammation, nausea and diarrhea, with no unexpected safety findings. Revolution Medicines is preparing a rolling new drug application to the FDA and plans further global regulatory filings. Median survival in the metastatic setting has barely moved in two decades, which is why ASCO investigators described the data as unprecedented for previously treated metastatic pancreatic ductal adenocarcinoma. Sources: ASCO press center, Revolution Medicines investor release, NEJM.

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