Pancreatic cancer drug daraxonrasib from Revolution Medicines succeeds in trial

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, which 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%. 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.

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

He’s been involved in trials for RevMed’s daraxonrasib since its early days, and choked up multiple times when describing the results and what they mean for patients, including one who participated in the pivotal trial that Pant had seen just before the interview.

“Today, I’m just, I’m just thankful,” Pant said. “That’s all I can say. And you know, just seeing patients in my clinic today, I’ve got a busy clinic today, and I’m just thankful.”

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

Sasse said his tumors have shrunk 76% since he started taking the drug, but said it causes “crazy” side effects like a facial rash. His face appeared to be peeling during the interview.

RevMed’s CEO 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. Pant couldn’t speak to the specifics of Sasse’s case, but said the majority of patients in previous trials of daraxonrasib did experience a rash, though less than 10% of them developed a “dramatic” rash. He said strategies like stopping the drug temporarily or treating with antibiotics can help.

“Honestly, since our journey three years ago, we are getting better at managing these side effects, and I think we keep on getting better at managing side effects,” Pant said.

RevMed on Monday said the drug showed a manageable safety profile in the pivotal study and that no new concerns were observed. The full results will be disclosed at a medical meeting.

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.

Daraxonrasib could become a foundation that can be built upon and used in combination with other drugs, said Dr. Andrew Aguirre, associate director of the Hale Family Center for Pancreatic Cancer Research and co-director of the Center for RAS Therapeutics at Dana-Farber Cancer Institute. The results are a “whopping improvement” to be “incredibly excited about as really a foundation,” he said.

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

Revolution Medicines shares jumped more than 30% following release of the results Monday. Its stock has climbed about 274% in the last year, in part because it has long been seen as an acquisition target.

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