Revolution Medicines says daraxonrasib extended survival in phase 3 pancreatic cancer study

Revolution Medicines said patients with advanced pancreatic adenocarcinoma treated with its daily pill daraxonrasib lived a median of 13.2 months in a Phase 3 study, compared with 6.7 months for patients who received standard chemotherapy. The company said it plans to use the data to apply for Food and Drug Administration approval, while the drug has also received a Commissioner’s National Priority Voucher intended to accelerate the review process.

Metastatic pancreatic cancer patients who received the targeted pill lived nearly twice as long as patients who received chemotherapy, a striking result in an especially deadly and intractable malignancy. The five-year survival rate for pancreatic cancer trends around 5% in the metastatic setting, and patients are often diagnosed with advanced stages of the disease when surgery is not something clinicians can offer.

Over 90% of patients diagnosed with pancreatic cancer have a mutation in KRAS. Daraxonrasib is described as a RAS(ON) inhibitor that binds to the activating pocket of KRAS and shuts it down, a targeted therapeutic approach after decades of work trying to figure out how to target RAS.

The FDA review process usually takes up to 10-12 months after a company submits a drug application. The expedited pathway could allow patients to access a drug faster if the data are positive, although potential gastrointestinal side effects such as nausea, vomiting, and diarrhea are known effects of this class of medication and toxicity remains an important consideration.