This might be the biggest breakthrough in pancreatic cancer in decades

For decades, a genetic mutation found in nearly 90 percent of pancreatic cancer tumors was considered impossible to target with drugs. Now, after successful rounds of clinical trials, researchers are closing in on a drug that targets the mutation, offering a rare chance to extend survival in one of the deadliest cancers.

“The possibility is unlike, really, anything we've seen in pancreatic cancer in many years,” says Chris Chen, an oncologist at Stanford University School of Medicine. “I think this is truly an earth-shattering moment in pancreatic cancer.”

Targeting KRAS marks a turning point

Earlier this month, a phase 3 clinical trial— the second-to-last stage of drug testing—found that a medicine called daraxonrasib, designed to target the genetic mutation, may nearly double survival outcomes in patients with pancreatic cancer when combined with chemotherapy.

The affected gene, called KRAS, helps regulate cell growth. But when it mutates, cells “just keep dividing and growing and dividing until it practically snuffs out the life of the patient,” says

Olatunji Alese, an oncologist at Emory University’s Winship Cancer Institute who specializes in gastrointestinal cancers.

KRAS mutations are not unique to pancreatic cancer, but they are present in the vast majority of pancreatic tumors. Drugs like daraxonrasib are designed to home in on that defect, binding to the altered protein and blocking the signals that drive uncontrolled growth.

In its most recent trial phase, patients who received the drug lived a median of 13.2 months, compared with 6.7 months for those who did not. It may not sound like an exciting increase—just under six months—“but in pancreas cancer, it's a lot, unfortunately,” says Matthew Katz, a surgical oncologist at The University of Texas MD Anderson Cancer Center. “In the patient population that was being evaluated, six months is huge. It is a definite win.”

It’s also an advancement that some doctors once believed improbable—if not impossible. The mutations were first discovered in the early ‘80s, but it wasn’t until more than three decades later, in 2013, that researchers learned inhibitory compounds could bind the mutant genes and stop their signals. Suddenly, targeted treatment of KRAS in pancreatic cancer wasn’t a pipe dream.

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Since that breakthrough, doctors and drug manufacturers have been racing to create a medication that could incorporate the findings and specifically attack KRAS in pancreatic cancer. The first KRAS-inhibiting drug was approved by the FDA in 2021 for lung cancer, but it wasn’t potent enough to treat pancreatic cancer. Daraxonrasib, a once daily oral medication, could usher in a new generation of drugs, this time, ones that are strong enough to treat pancreatic cancer, which is more sensitive to KRAS signals and requires more complete blockage than lung cancer, Chen says.

Daraxonrasib may be leading this new wave, but it’s far from the only drug in testing. “By the last count, [there were] more than 70 [pancreatic cancer KRAS inhibitors] in the pipeline,” Alese says. Researchers plan to submit the drug for regulatory review soon. U.S. regulators have also identified daraxonrasib as a high-priority therapy, a designation that could speed its review timeline to just a few months.

Expanding the treatment landscape

Until new drugs are approved, chemotherapy by itself remains the standard of care for pancreatic cancer. But unlike targeted therapies, chemotherapy attacks both cancerous and healthy cells, often leading to more severe side effects.

The use of KRAS inhibitors wouldn’t eliminate the need for chemo, but “it may be superior to chemotherapy in patients who've had prior chemotherapy once before,” says Brian Wolpin, an oncologist at the Dana-Farber Cancer Institute’s Center for Gastrointestinal Oncology and an investigator on the drug trial.

Beyond having potentially fewer side effects than a second round of chemo, the drug could make the treatment process less intense. “You don’t have to come in for IV infusions or wear a pump at home that delivers the chemo,” Wolpin explains, “It is, I think, more convenient.”

In addition to being used in conjunction with chemo, KRAS inhibitors could be used alongside other treatments researchers are actively studying, including mRNA vaccines, though that’s still far off. Early findings from a very small, recent trial suggest mRNA vaccines could prevent pancreatic cancer from recurring.

Among the patients who responded, most were still alive six years later. But some researchers have hesitations about how likely it is that mRNA vaccines will become a leading treatment for such a deadly cancer: “The idea that the first effective cancer vaccine is going to be against pancreas cancer—strange believability,” says Robert Eil, a surgical oncologist and immunotherapy researcher at Oregon Health & Science University.

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If not a leading treatment, vaccines like these could become a weapon in a doctor’s growing arsenal of pancreatic cancer treatments, and would likely be most effective before the cancer is very advanced, Alese says. In the case of pancreatic cancer, it’s rarely diagnosed that early.

The challenge of early detection continues to shape outcomes. Unlike breast or colorectal cancer, there is no screening test for pancreatic cancer. There are also few early warning signs, and it can spread early. The combination of these factors is why most pancreatic cancer patients are first diagnosed at stage IV. At that point, the disease has already metastasized, and the five-year survival rate is only 3 percent.

“You need to find it earlier, and you need to have more effective ways to treat it,” Wolpin says. “You put those two things together, and we would hope we would be able to cure a lot more people if we could do that.”

Even with those limitations, researchers say advances in targeting KRAS represent a meaningful shift after decades of slow progress. “I think KRAS inhibition is very likely to radically change how we treat the disease,” Wolpin says. “We’ve wanted to be able to do this for several decades, but have not had the tools to do that, and now that the chemistry has moved forward, this could really change, I think, how we treat pancreatic cancer, and I think it will be very different in the years to come.”