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An experimental oral drug, daraxonrasib, nearly doubled median survival for patients with previously treated metastatic pancreatic ductal adenocarcinoma in a randomized Phase 3 trial, researchers reported at the American Society of Clinical Oncology (ASCO) meeting in Chicago.
The 500-patient RASolute-302 study found median overall survival of about 13.2 months on daraxonrasib versus roughly 6.6â6.7 months for investigatorâchoice chemotherapy (hazard ratio ~0.40). Daraxonrasib also improved progressionâfree survival and objective response rates and was associated with fewer treatment discontinuations; common adverse effects included rash and mucositis.
The data were published in the New England Journal of Medicine.
The drug, developed by Revolution Medicines, targets RAS/KRAS by locking the active protein and has received FDA Breakthrough and Orphan designations; the company has applied to U.S. regulators and the FDA is allowing expanded access while reviewing the filing.
Canadian specialists at Princess Margaret Cancer Centre said they plan to open local clinical trials because Health Canada has not yet received a licensing application.
Researchers are testing daraxonrasib earlier in treatment and in other RASâdriven tumours, but questions remain about the durability of benefit as resistance eventually emerges.
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