Survival doubled in landmark pancreatic cancer trial
An experimental drug called daraxonrasib has doubled survival time for patients with advanced pancreatic cancer, oncologists announced this week, calling the results a “watershed moment” for a disease that has long resisted treatment. The drug, developed by Revolution Medicines, is already on a fast track for FDA approval, and an expanded access program now allows patients outside clinical trials to receive it.
The findings come from a Phase 3 clinical trial whose early results were released in April 2026, followed by publication of earlier-phase data in The New England Journal of Medicine on May 6. Patients who received daraxonrasib in combination with chemotherapy lived twice as long as those who received chemotherapy alone. In patients whose cancer had already spread, the drug stopped tumor growth for more than eight months and extended survival to nearly a year and a half.
“We have been desperately working very hard trying to find other ways to treat the cancer,” said Dr. Brian Wolpin, who led the research and directs the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute. “This really feels like a watershed moment. It’s going to shift how we think about treatment for pancreatic cancer overall.”
Targeting the ‘undruggable’ KRAS mutation
Pancreatic cancer is one of the most lethal malignancies, largely because it is typically diagnosed only after it has spread. Fewer than 3% of patients with metastatic disease live five years, according to the American Cancer Society. The reason lies deep in the cancer’s biology: more than 90% of pancreatic tumors carry a mutation in the KRAS gene, which controls cell growth. The mutation locks the RAS protein into a permanent “on” position, driving uncontrolled cell proliferation.
For decades, RAS was considered “undruggable.” Countless attempts to block it failed. Daraxonrasib succeeds through a novel mechanism: it acts as a “molecular glue,” pairing with a protein called cyclophilin A inside cells. The combination latches onto RAS and shuts it down.
“We are witnessing a true turning point in pancreatic cancer research,” said Dr. Alexander I. Spira, co-director of the Virginia Cancer Specialists Research Institute, which served as a leading clinical trial site. “KRAS mutations have long represented one of oncology’s greatest challenges. These results demonstrate that precision-targeted therapies like daraxonrasib may finally change outcomes for patients facing a devastating diagnosis.”
Disease control in nearly 90% of patients
The Phase 1/2 trial published in NEJM showed that nearly 90% of patients achieved disease control after treatment with daraxonrasib. The Phase 3 results confirmed the drug’s clinical impact, reinforcing expectations for regulatory approval.
Virginia Cancer Specialists and NEXT Oncology were selected as prominent trial sites, reflecting the strength of their community-based research program. Through a joint venture, patients in the Fairfax, Virginia area gained early access to the therapy. “Our role in this historic study underscores our commitment to advancing cancer care through research,” Dr. Spira added.
AI biomarker fills a critical gap for non-responders
While daraxonrasib represents a leap forward, another advance published on May 12, 2026 addresses a different challenge: monitoring treatment response. About a third of pancreatic cancer patients do not produce elevated levels of the standard biomarker CA19-9, making it impossible to track whether therapy is working using conventional blood tests.
Researchers at the Medical College of Wisconsin developed an AI-derived tumor marker using routine laboratory data. “This behaves just like CA19-9 does clinically,” said Dr. Anai N. Kothari, assistant professor of surgical oncology. “It tracks response, predicts outcomes and can help guide treatment decisions. This really is a step forward using AI, not just to predict outcomes, but to fill in some critical gaps in clinical care using data we already have.”
The AI biomarker, described in JAMA Surgery, predicted treatment completion and survival with similar accuracy to CA19-9 in patients who had measurable levels of that marker. For the 30% who lack CA19-9, the tool offers a non-invasive, low-cost way to determine whether a treatment like daraxonrasib is working or whether a change in strategy is needed.
What this means for patients and the field
The arrival of daraxonrasib marks a fundamental shift in how pancreatic cancer is treated. For the first time, a targeted therapy can directly attack the genetic driver of the disease rather than relying solely on broad chemotherapy. The drug’s rapid path to expanded access and likely FDA approval means patients may begin receiving it within months rather than years.
“This really feels like a watershed moment,” Dr. Wolpin said. “It’s going to shift how we think about treatment for pancreatic cancer overall.”
The combination of a powerful new drug and an AI tool to monitor its effects could dramatically improve outcomes for a cancer that has seen little progress in decades. While daraxonrasib is not a cure—patients still face a difficult prognosis—the doubling of survival time offers a meaningful extension of life and, for some, the possibility of seeing new therapies that may follow.
As the FDA reviews daraxonrasib for full approval, researchers are already exploring whether the drug could be effective in earlier stages of the disease or in combination with other agents. The “undruggable” protein has finally met its match, and the era of precision medicine for pancreatic cancer has begun.
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