The article emphasizes that the data are preliminary and exclusive to STAT+, indicating subscriber access is required for the full story.

Revolution Medicines reported that its pancreatic cancer drug daraxonrasib nearly doubles median overall survival in a Phase 3 trial, improving from 6.7 months with chemotherapy to 13.2 months.

In the trial, patients on daraxonrasib averaged 13.2 months of survival versus 6.7 months on standard chemotherapy, a 6.5-month gain and a 60% reduction in the risk of death.

The company announced that daraxonrasib met all primary and secondary endpoints in the Phase 3 study and significantly improved survival compared with chemotherapy.

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The FDA rejection notes highlighted difficulty in isolating the virus treatment’s effects when used with an approved PD-1 checkpoint inhibitor, fueling ongoing debate about FDA review standards for combination therapies and accelerated approval pathways.

Independent experts not involved in the study described the result as very impressive and potentially meaningful in a hard-to-treat cancer.

The drug showed a manageable safety profile with no new safety concerns, with rash as a known, typically manageable side effect.

The report is an excerpt from STAT, with full details available to STAT+ subscribers.

Revolution Medicines characterized the results as unprecedented, noting no prior Phase 3 pancreatic cancer trial has shown an overall survival benefit greater than one year, and the CEO suggested the findings could be practice-changing and may pursue FDA approval soon via a National Priority Voucher.

The company plans to seek approval for second-line use and is conducting a Phase 3 trial for newly diagnosed patients, with additional trials in progress.

Daraxonrasib targets RAS mutations, present in about 90% of pancreatic cancers, potentially signaling a new era of RAS-targeted therapy for this disease.