Pancreatic cancer, illustration
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Revolution Medicines‘ drug for pancreatic cancer succeeded in a highly anticipated Phase 3 trial, almost doubling the typical length of survival and slashing the risk of death by 60% versus chemotherapy, the company said Monday.
RevMed said its daily pill, daraxonrasib, met all primary and secondary endpoints in a trial of people whose cancer had already progressed on another treatment. People who took daraxonrasib typically lived for 13.2 months versus 6.7 months for people who took chemotherapy, an increase of 6.5 months, RevMed said in a press release.
“These are dramatic, practice-changing outcomes, and our focus now is moving quickly to bring this potential new treatment option to patients who urgently need new treatment,” RevMed CEO Mark Goldsmith said in an interview.
Goldsmith called the results “unprecedented,” saying no drug has shown an overall survival benefit greater than one year in a Phase 3 trial for pancreatic cancer. The company plans to soon seek Food and Drug Administration approval using a Commissioner’s National Priority Voucher that grants a review within a matter of months.
RevMed’s pill could bring a new option for people with pancreatic cancer, an aggressive disease that has the lowest five-year survival rate of any major cancer, at 13%. The drug, daraxonrasib, broadly targets RAS mutations, which drive tumor growth and are found in about 90% of pancreatic cancer cases.
“These results usher in a new era of RAS-targeted medicines for pancreatic cancer, which has been exclusively treated with cytotoxic intravenous chemotherapy,” Goldsmith said.
The company’s shares jumped more than 30% following release of the results Monday.
RevMed said the drug showed a manageable safety profile and that no new concerns were observed. The drug can produce rash, a side effect highlighted last week by former Republican Sen. Ben Sasse, who shared his experience taking the drug in an interview with The New York Times. Goldsmith said the company can’t comment on any individual patient, but that a rash is a known side effect and one that’s generally manageable.
The company will seek approval for second-line treatment, or in patients whose cancer has already spread while taking another drug. It’s conducting a Phase 3 trial for newly diagnosed patients.