revolutionary medicineThe company announced Monday that its pancreatic cancer drug successfully completed its long-awaited Phase 3 trial, nearly doubling normal survival and reducing the risk of death by 60% compared to chemotherapy.
RevMed said its daily drug dalaxone lasib met all primary and secondary endpoints in a trial in patients whose cancer had already progressed on other treatments. RevMed said in a press release that those who received chemotherapy lived 6.7 months longer, 6.5 months longer, compared to the typical 13.2 months for those who took dalaxone lasib.
“These are dramatic, practice-changing results, and we are now working quickly to bring this potential new treatment option to patients who urgently need new treatments,” 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 for pancreatic cancer. The company plans to seek approval from the Food and Drug Administration soon, using the Secretary’s National Priority Voucher, which will be approved for review in the coming months.
RevMed’s pill could offer a new option for pancreatic cancer patients. Pancreatic cancer is a highly malignant disease with the lowest five-year survival rate of 13% among major cancers. Dalaxone lasib broadly targets RAS mutations that promote tumor growth and are found in approximately 90% of pancreatic cancer cases.
“These results herald a new era of RAS-targeted drugs for pancreatic cancer that has been treated exclusively with cytotoxic intravenous chemotherapy,” said Goldsmith.
Dr. Shubham Pant, professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center, said these results are “truly transformative” for patients. Pant said he has participated in many other studies that have failed, and that previous positive trials have extended survival by weeks or months.
He was involved in RevMed’s dalasonelasib trial early on, and his voice choked up multiple times when explaining the results and what they meant for patients. Among them were participants in a pivotal clinical trial that Pant had seen just before the interview.
“I’m just so grateful for today,” Pant said. “That’s all I can say. And you know, even just seeing patients in the clinic today, it’s a busy clinic today, so I just appreciate it.”
Dalasonelasib received further attention last week after former Republican senator Ben Sasse, who was diagnosed with pancreatic cancer late last year and was given only months to live, revealed his experience taking the drug in an interview with the New York Times. He told the Times that Pant was his doctor.
Mr Sasse said his tumor had shrunk by 76% since he started taking the drug, but it caused “ridiculous” side effects, including a rash on his face. During the interview, his face appeared to be peeling.
RevMed CEO Goldsmith said the company could not comment on individual patients, but said the rash is a known side effect and generally manageable. Pant could not discuss the details of Sasse’s case, but said that in previous trials of dalaxone lasib, the majority of patients experienced a rash, but less than 10% developed a “dramatic” rash. Strategies such as temporarily stopping the drug or treating with antibiotics may be helpful, he said.
“Honestly, since we started doing this three years ago, we’ve gotten better at dealing with these side effects, and I think we’ll continue to get better at dealing with them,” Pant said.
RevMed said Monday that the drug had a manageable safety profile in a pivotal study and no new concerns were observed. Full results will be disclosed at a medical conference.
The company plans to seek approval for second-line therapy, or for patients whose cancer has already metastasized while taking another drug. Phase 3 trials are being conducted in newly diagnosed patients.
Daraxonelasib could be a foundation that can be built on and used in combination with other drugs, said Dr. Andrew Aguirre, associate director of the Hale Family Pancreatic Cancer Research Center and co-director of the RAS Treatment Center at Dana-Farber Cancer Institute. The results were a “remarkable improvement” and “really fundamental and incredibly exciting,” he said.
“And to be honest, targeting the RAS in this patient population, and hopefully targeting many other conditions in pancreatic cancer and many other hard-to-treat diseases, is something that has real benefits for patients and something that we can continue to expand on and use in combination is reason for optimism for the field as a whole,” Aguirre said.
Revolution Medicine’s stock price rose more than 30% following Monday’s earnings report. The company’s stock price rose about 274% last year, in part because the company has been seen as an acquisition target.
Monday’s stock price change gave the company a market value of more than $26 billion. Goldsmith said the company is focused on preparing for drug approval and launch rather than potential acquisitions.
