Pancreatic Cancer Drug Daraxonrasib Nearly Doubles Survival

For decades, a diagnosis of metastatic pancreatic cancer has been among the most devastating news a patient can receive. The disease is often caught late, resists most therapies, and kills the overwhelming majority of patients within a year. So when researchers stood before a packed plenary session at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago and presented data on an experimental pill, the response was unusually charged for an oncology conference: a standing ovation.

The drug is daraxonrasib, an oral RAS inhibitor developed by Revolution Medicines. In the pivotal Phase 3 RASolute 302 trial, it roughly doubled overall survival compared with standard chemotherapy in patients whose pancreatic cancer had already progressed after prior treatment. The figures are striking for a cancer that has seen little meaningful progress in more than a decade, though experts are careful to frame the results as a major step forward rather than a cure.

What the RASolute 302 trial actually showed

RASolute 302 enrolled roughly 500 patients with previously treated metastatic pancreatic ductal adenocarcinoma, or PDAC, randomly assigning them to receive either daraxonrasib or chemotherapy. In the intent-to-treat population, patients on the drug had a median overall survival of 13.2 months, compared with 6.7 months for those on chemotherapy. The hazard ratio was 0.40 (P less than .0001), which translates to a 60 percent reduction in the risk of death.

Progression-free survival, the time before the cancer worsened, also roughly doubled, reaching 7.2 months versus 3.6 months on chemotherapy. The trial met all of its primary and key secondary endpoints. In the subset of patients carrying RAS G12 mutations, daraxonrasib reduced the risk of death by 60 percent versus chemotherapy. More than 90 percent of trial participants carried a KRAS mutation, reflecting how common these alterations are in the disease.

Daraxonrasib is taken as a 300 mg pill once daily, a notable contrast to the intravenous chemotherapy regimens that have long defined pancreatic cancer care.

Why pancreatic cancer has been so hard to beat

Pancreatic cancer remains one of the deadliest common malignancies. Among patients diagnosed with metastatic disease between 2015 and 2021, roughly 97 percent died within five years. Several features make it formidable. The pancreas sits deep in the abdomen, the disease rarely causes noticeable symptoms early, and there are no effective screening tests, so most cases are found only after the cancer has spread. The tumors are also notoriously resistant to chemotherapy.

At the molecular root of the problem is RAS. More than 90 percent of pancreatic tumors carry mutations in the KRAS gene that lock cellular growth signals permanently in the "on" position, fueling relentless proliferation. For decades scientists considered RAS "undruggable." As oncologist Christopher Lieu, professor of medical oncology at the University of Colorado Anschutz, has explained, the KRAS protein surface is exceptionally smooth and lacks the molecular pockets that conventional drugs need to grab onto and switch off.

How daraxonrasib works

Daraxonrasib belongs to a new class that the company describes as multi-selective RAS(ON) inhibitors. Rather than trying to bind the smooth surface of RAS directly, the drug attaches to a molecule called cyclophilin A, a protein that helps fold other proteins. That complex then binds to the active form of RAS and shuts down its ability to signal cancer cells to multiply.

The approach matters because earlier RAS-targeted drugs were limited to single variants, most notably KRAS G12C, which accounts for only a small fraction of pancreatic cancers. Daraxonrasib is designed to act against a broader spectrum of RAS mutations, which is particularly relevant in PDAC given the diversity of alterations seen in the disease. That breadth is a central reason the trial population could include the large majority of patients rather than a narrow biomarker-defined slice.

What oncologists are saying

Specialists who treat the disease described the results as a watershed. "The results were jaw-dropping and represent the most significant advance we have ever seen in pancreatic cancer," said Anna Berkenblit, MD, MMSc, chief scientific and medical officer of the Pancreatic Cancer Action Network.

Others emphasized the depth of unmet need that the data begin to address. "For patients with metastatic pancreatic cancer, new treatment options are urgently needed," said Brian M. Wolpin, MD, MPH, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute. The enthusiasm reflects how rare positive trials have been in this setting, where most experimental therapies have failed to move the survival needle at all.

Side effects and the limits of the data

Daraxonrasib was generally well tolerated, with what investigators called a manageable safety profile and no new safety signals. The most common side effect was a prominent skin rash, reported in 86 percent of patients, with 14 percent severe. Stomatitis, or mouth inflammation, occurred in 54 percent, with 12 percent severe, along with diarrhea, nausea and vomiting. Importantly, only about 1 percent of patients stopped daraxonrasib because of severe side effects, compared with roughly 11 percent on chemotherapy.

The data also come with real caveats. The trial enrolled too few patients with KRAS wild-type tumors to draw conclusions about whether the drug helps that minority. The results were studied in previously treated patients, so daraxonrasib's role earlier in the disease course remains an open question. And while median survival doubled, 13.2 months still underscores how far pancreatic cancer care has to go.

The path to FDA approval

Revolution Medicines has said it intends to submit the data to global regulators, including the U.S. Food and Drug Administration, as part of a future New Drug Application. The drug already carries FDA Breakthrough Therapy Designation, granted in June 2025, and Orphan Drug Designation for previously treated metastatic PDAC harboring G12 mutations. The company has indicated it plans to pursue review under a Commissioner's National Priority Voucher, a mechanism intended to speed evaluation, and an expanded access program was authorized in May 2026.

No firm approval date has been set, and the drug is not yet available outside trials and access programs. Still, for a disease that has frustrated researchers and devastated families for generations, the RASolute 302 results represent something patients with pancreatic cancer have rarely had: a credible reason for optimism. If the full data hold up under regulatory scrutiny, oncologists say daraxonrasib could redefine the standard of care for one of the cancers that has resisted progress the longest.