New drug to treat one of the deadliest cancers is 'the real deal,' oncologist says

MURRAY — Dr. Mark Lewis said in the field of gastrointestinal oncology, progress can take years, or decades, but this most recent breakthrough is the biggest he has seen in his career.

He called it "truly remarkable" and a "game changer" in how pancreatic cancer is treated.

Until now, the only options for managing stage four pancreatic cancer have required intravenous chemotherapy every two weeks. In trials, the new drug, daraxonrasib, doubled survival time for the stage 4 cancer patients, from 6.7 months on chemotherapy to 13.2 months.

Often, cancer patients are offered hope rather than treatment, but Lewis, director of gastrointestinal oncology at Intermountain Health, told media on Tuesday this medication is "the real deal."

Optimistic and realistic

The drug has not yet been approved by the Food and Drug Administration, but Intermountain Health is now able to provide it to people under what is called an Extended Access Program, along with the Huntsman Cancer Institute and Utah Cancer Specialists.

The program, Lewis said, is limited to patients who are approved and is similar to an individual trial. He said Intermountain Health now has nine patients who are approved for the program and are now waiting for the first shipment of medication straight from the manufacturer.

The doctor clarified that daraxonrasib is not a cure but is a way to control pancreatic cancer. The only cure for pancreatic cancer is surgery, Lewis said, but that is most often not an option for stage 4 patients.

The treatment does come with some serious side effects, most notably rash, diarrhea and mouth sores. Lewis expressed admiration for former U.S. Sen. from Nebraska, Ben Sasse, who has been participating in trials for the drug and has talked about his rash in public. Although side effects can be measured, he said it is hard for others to measure the trade-offs a cancer patient needs to consider in order to live with their disease.

His patients who are moving forward with the new treatment are "optimistic, but also realistic." They understand this pill can offer them more meaningful time, and possibly fewer side effects and, on average, more than a year of life.

"I wish I could hand them a pill and say 'this is going to cure your pancreas cancer' and that's not what this is. What it is, though, is potentially a treatment that's better tolerated and more effective for longer than intravenous chemotherapy for the rest of your life," he said.

A serious disease

The study supporting the medication was presented at this year's American Society of Clinical Oncology conference, and it got a standing ovation.

Pancreatic cancer is an "incredibly serious" health problem, Lewis said. About 67,000 Americans are diagnosed each year, and of those roughly 52,000 die from the disease, the American Cancer Society reports. It is the third leading cause of cancer deaths.

This cancer is partially so deadly because there is no screening process, and so often when it his found, the cancer has wrapped itself around and can't be cut out, or it has moved into other areas of the body.

Lewis explained that the mutation in most pancreatic cancers is called KRAS, and daraxonrasib is the first to address that mutation directly. It has been found to be effective at shutting down the growth signals caused by KRAS, stopping its growth and spread.

"This is a big leap forward, and frankly, this is the start. This is the first treatment that is effectively going after this RAS mutation. I imagine in the future we'll see more and more," Lewis said.

He called it a "very exciting start" to a new evolution of treatment options. It represents a growing trend in cancer treatments to provide precision treatments targeted specifically at the cancer.

Pancreatic cancer creates a shell around itself, making it harder for chemotherapy to penetrate. It is also hard to treat because blood flow goes from the pancreas to the liver, making it more likely that it will metastasize.

Early pancreatic cancer symptoms can feel like an upset stomach or heartburn. Some early signs include developing diabetes while losing weight. Later, patients may develop jaundice, showing the cancer has spread to their liver.

Hope

According to Lewis, daraxonrasib will likely not be used for patients whose chemotherapy is working and tolerable, and it has only been tested on patients with stage 4 pancreatic cancer. The trial for this specific drug has only run for about two years, which he said is really fast in oncology, but it has gone through the required phases to evaluate its safety and effectiveness.

An application for the FDA to approve the drug was submitted on July 22, and he said it will often take around six to eight weeks to be considered, so the treatment may be available to more patients in just a few weeks.

Ten Intermountain Health hospitals have been approved to provide the treatment through the expanded access program, including multiple in Colorado and Montana, Lewis said. Intermountain Health is "trying to make sure that where you live doesn't limit your access to the drug."

Dr. Ned Jones, an oncologist in Grand Junction, Colorado, said access to effective cancer treatment is critical, especially for patients who live in smaller communities.

"We are thrilled to have early access to a promising and desperately needed therapy for our patients with pancreatic cancer," he said. "The data from this study generated considerable excitement among the oncology community and highlight the potential for meaningful progress in a disease where advances in treatment have been difficult to achieve."

Dr Alicia Swink, who is also based in Grand Junction, said seeing advancements like this gives caregivers and patients "real hope."

"This is about more than a new drug – it's about giving patients more time and more options," she said.

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