Medicines of the revolution'The pancreatic cancer drug was successful in a highly anticipated Phase 3 trial, nearly doubling the typical length of survival and reducing the risk of death by 60% compared to 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 taking daraxonrasib typically lived 13.2 months versus 6.7 months for people taking chemotherapy, an increase of 6.5 months, RevMed said in a news release.
“These are dramatic, practice-changing results, and our focus now is to move quickly to bring 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 has shown an overall survival benefit of more than one year in a Phase 3 trial for pancreatic cancer. The company plans to soon seek approval from the Food and Drug Administration using a Commissioner's National Priority Voucher, which grants a review within 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 broadly targets RAS mutations, which drive tumor growth and are found in approximately 90% of pancreatic cancer cases.
“These results usher in a new era of RAS-targeting drugs for pancreatic cancer, which has been treated exclusively with cytotoxic intravenous chemotherapy,” Goldsmith said.
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 many other studies that have failed, and said previous positive trials extended survival by a few weeks or months.
He has been involved in trials for RevMed's daraxonrasib since their inception, and choked up several times 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 am just grateful,” Pant said. “That's all I can say. And you know, just seeing patients in my clinic today, I have a busy clinic 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, 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 he said it causes “crazy” side effects like a facial rash. His face appeared to be peeling during the interview.
RevMed CEO Goldsmith said the company can't comment on any individual patient, but that a rash is a known and generally manageable side effect. Pant could not discuss the details of Sasse's case, but said that most 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 can help.
“Honestly, since our trip three years ago, we are getting better at managing these side effects, and I think we continue to get better at managing the side effects,” Pant said.
RevMed said Monday that the drug showed a manageable safety profile in the pivotal study and that no new concerns were noted. Full results will be announced at a medical meeting.
The company will seek approval for second-line treatments or in 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 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 RAS Therapeutics Center at Dana-Farber Cancer Institute. The results are a “huge improvement” to be “incredibly excited about as if they were really baseline,” he said.
“And, honestly, it's cause for optimism for the entire field that targeting RAS in this patient population, and hopefully in many other settings for pancreatic cancer and many other difficult-to-treat diseases, has a real benefit for patients and is something that we can continue to expand and use in combination,” Aguirre said.
Revolution Medicines shares rose more than 30% following the release of results on Monday. Its shares have risen about 274% in the past 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 the approval and launch of its drug, rather than any potential acquisition.
