Revolution Medicines’ pancreatic cancer drug daraxonrasib was successful in the study

Revolutionary drugsThe company said Monday that the pancreatic cancer drug succeeded in a highly anticipated Phase 3 trial, nearly doubling typical survival times and reducing the risk of death by 60% compared with chemotherapy.

RevMed said its daily pill daraxonrasib met all primary and secondary endpoints in a study of people whose cancer had already progressed on other treatment. People who took daraxonrasib typically lived 13.2 months compared to 6.7 months for people who received chemotherapy, an increase of 6.5 months, RevMed said in a news release.

“These are dramatic, practice-changing results, and our focus now quickly turns to bringing this potential new treatment option to patients who urgently need a new treatment,” RevMed CEO Mark Goldsmith said in an interview.

Goldsmith called the results “unprecedented” and said no drug had shown an overall survival benefit of more than a year in a Phase 3 trial in pancreatic cancer. The company plans to soon seek approval from the Food and Drug Administration using a Commissioner’s National Priority Voucher, which allows for 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 any major cancer at 13%. Daraxonrasib largely targets RAS mutations, which drive tumor growth and occur in about 90% of pancreatic cancer cases.

“These results usher in a new era of RAS-targeted drugs for pancreatic cancer, which has previously been treated exclusively with cytotoxic intravenous chemotherapy,” said Goldsmith.

For patients, these results are “truly transformative,” said Dr. Shubham Pant, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center. Pant said he has been involved in numerous other trials that have failed and said previous positive trials have extended survival by a few weeks or months.

He had been involved in studies of RevMed’s daraxonrasib since its early days and choked up several times as he described the results and what they meant for patients, including one who was part of the pivotal trial that Pant had seen just before the interview.

“Today I’m just grateful,” Pant said. “That’s all I can say. And you know, just seeing patients in my clinic today, my clinic is very busy today, and I’m just grateful.”

Daraxonrasib gained more attention last week when former Republican Senator Ben Sasse, who was diagnosed with pancreatic cancer late last year and given just months to live, recounted his experience taking the drug in an interview with The New York Times. He told the Times that Pant was his doctor.

Sasse said his tumors have shrunk by 76% since he started taking the drug, but said it causes “crazy” side effects such as a facial rash. His face seemed to peel during the interview.

RevMed CEO Goldsmith said the company cannot comment on individual patients, but that a rash is a known and generally manageable side effect. Pant couldn’t comment on the details of Sasse’s case, but said the majority of patients in previous trials of daraxonrasib experienced a rash, although fewer than 10% of them developed a “dramatic” rash. He said strategies such as temporarily stopping the medication or treating with antibiotics could help.

“Honestly, since our journey three years ago, we have gotten better and better at dealing with these side effects, and I think we are getting better and better at dealing with side effects,” Pant said.

RevMed said Monday that the drug demonstrated a manageable safety profile in the pivotal trial and that no new concerns were identified. Full results will be announced at a medical meeting.

The company will seek approval for second-line treatment or for patients whose cancer has already spread while taking another drug. It is conducting a Phase 3 trial for newly diagnosed patients.

Daraxonrasib could become a foundation on which to build and be used in combination with other drugs, said Dr. Andrew Aguirre, deputy director of the Hale Family Center for Pancreatic Cancer Research and co-director of the Center for RAS Therapeutics at the Dana-Farber Cancer Institute. The results are a “tremendous improvement” that is “incredibly exciting as a real baseline,” he said.

“And frankly, there is reason for optimism across the field that targeting RAS in this patient population and hopefully many other contexts for pancreatic cancer and many other difficult-to-treat diseases will have real benefit for patients and will be something that we can continue to expand and use in combination,” Aguirre said.

Shares of Revolution Medicines rose more than 30% following the earnings release on Monday. The company’s stock is up about 274% in the last year, partly because the company has long been considered a takeover target.

Monday’s stock move pushes the company’s market value to over $26 billion. Goldsmith said the company is focused on preparing for approval and launch of its drug, rather than a potential acquisition.