Ben Sasse shines spotlight on daraxonrasib for pancreatic cancer

Revolution Medicines may be on the verge of a breakthrough.

The company expects to soon release results from a Phase 3 trial of its experimental drug, which could be the first targeted therapy for pancreatic cancer, the deadliest of major cancers. Only 13% of people with pancreatic cancer live five years after diagnosis; That number hasn’t changed much even as the outlook for other cancers has improved thanks to new drugs like immunotherapy. The prospect of a new treatment has sent RevMed’s shares soaring nearly 185% in the past year, making it a prime acquisition target.

“This is incredibly important,” RBC Capital Markets analyst Leonid Timashev said. “We’ve seen doctors describe this as the biggest breakthrough ever in pancreatic cancer.”

RevMed put former Senator Ben Sasse in the spotlight this week. he told the New York Times It takes the company’s drug, daraxonrasib. Sasse announced late last year that he had been diagnosed with Stage 4 pancreatic cancer and was given three to four months to live.

Sasse told the Times that his tumors had shrunk 76 percent since he started treatment, but that it was a “bad drug” that caused “crazy” side effects like rashes. Sasse’s bloody, peeling face prompted the interviewer to tell Sasse he looked “terrible.”

RevMed’s daily pill targets RAS mutations, which generally fuel tumor growth and are found in about 90% of pancreatic cancer cases. Timashev says RevMed’s drug is at the heart of what eliminates cancer.

This is both a benefit and a responsibility. RAS proteins are found everywhere in the body, especially in the skin. RevMed’s drug does not distinguish between the mutated version and the normal version, causing unpleasant side effects like the one Sasse experienced.

In a statement from RevMed, it was stated that the majority of rash cases were low-grade and therefore no patients discontinued treatment. The company added that reports of a hemorrhagic rash were described as anecdotal by clinical trial investigators and are considered a rare condition.

At first, RevMed wasn’t even sure if people could tolerate daraxonrasib because it was so broadly active against all the different forms of RAS, CEO Mark Goldsmith said. The company started with a “very, very low dose” and gradually increased the dose.

“We were worried about every tension,” he said. “Every time the team said we were about to increase the dose, a group of our seniors would sit in the conference room and put our heads in our hands and say, ‘Is this going to happen? Will we be able to go higher?’ “he thought.”

Goldsmith said the company’s scientists predicted that tumors would begin to shrink at 80 milligrams.

“They used science to predict this, and that’s exactly what happened,” he said. “We saw the first patient’s tumor shrink and we said, ‘Wow, our team is pretty good. They know how to predict these things.'”

But showing that the drug can shrink tumors likely won’t be enough to win approval from the U.S. Food and Drug Administration. Goldsmith said the agency’s need to demonstrate that RevMed’s daraxonrasib can keep people alive longer is both private and public; this is known in the medical community to benefit overall survival.

The size of that benefit could have important implications for how widely the drug will be used and how the company’s shares react to late-stage data. RevMed expects to share data this quarter from a Phase 3 trial examining the pill versus chemotherapy in people whose cancer has spread and who have already tried another treatment.

Analysts at RBC Capital Markets laid out their base case in a note to clients on Friday, predicting that RevMed’s stock would rise 25% to 40% if its drug showed an overall survival benefit of more than 13 months and cut the risk of death in half compared to chemotherapy. Timashev said it would be “incredibly disappointing” if the drug failed in its Phase 3 trial, and said that outcome was unlikely. A more likely risk, he says, is that the drug won’t provide as much benefit as investors expect.

Part of the recent rise in RevMed’s stock is due to speculation that the company will be acquired; Merck was reportedly looking at a deal earlier this year.

Goldsmith said RevMed isn’t paying much attention to “outside noise” and is focused on building the company.

“We know pharmaceutical companies are very interested in what we do,” he said. “They’re either trying to copy it, or they’re trying to take it over. And these things are going to happen all around us. Sometimes there will be rumors. What can we say? We’re not really focusing on how to get the company into other people’s hands? We’re focusing on how to make the most difference?”