Pancreatic cancer, illustration
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Breakthrough drugsThe pancreatic cancer drug has successfully completed a much-anticipated phase 3 trial, nearly doubling typical survival times and reducing the risk of death by 60% compared with chemotherapy, the company announced 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 generally lived 13.2 months compared to 6.7 months for people who received chemotherapy, an increase of 6.5 months, RevMed said in a press release.
“These are dramatic, practice-changing results, and our goal now is to quickly bring this potential new treatment option to patients who urgently need a new treatment,” Mark Goldsmith, CEO of RevMed, 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 pancreatic cancer trial. The company plans to seek approval from the Food and Drug Administration soon using a national priority voucher from the commissioner, which grants review within a few months.
RevMed’s pill could provide a new option for people with pancreatic cancer, an aggressive disease that has the lowest five-year survival rate of all major cancers, at 13 percent. Daraxonrasib broadly targets RAS mutations, which lead to tumor growth and are found in approximately 90% of pancreatic cancer cases.
“These results pave the way for a new era of RAS-targeting drugs for pancreatic cancer, which has been exclusively treated with intravenous cytotoxic chemotherapy,” Goldsmith said.
Shares of the company jumped more than 30% after reporting results on Monday.
RevMed said the drug had a manageable safety profile and no new concerns were observed. The drug can cause skin rashes, 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 could not comment on any specific patient, but that a rash was a known and generally manageable side effect.
The company will seek approval for a second-line treatment or in patients whose cancer has already spread while taking another drug. She is conducting a phase 3 trial for newly diagnosed patients.