BOSTON — A major clinical trial is offering new hope for patients battling one of the deadliest forms of cancer, Dr. Brian Wolpin of Dana-Farber Cancer Institute told Boston 25 News.
Researchers say a new targeted drug, daraxonrasib, significantly improved survival rates in patients with metastatic pancreatic cancer, according to results from a large international study presented at the American Society of Clinical Oncology Annual Meeting and published in the New England Journal of Medicine.
The findings could mark a major shift in how the disease is treated.
The phase 3 trial, known as RASolute 302, compared daraxonrasib to standard chemotherapy in patients whose cancer had already progressed after initial treatment.
Patients who received the new drug saw:
- Median overall survival nearly double — 13.2 months compared to 6.7 months with chemotherapy
- Longer progression-free survival — 7.2 months versus 3.6 months
- Higher tumor response rates — about 31.6% compared to 11.2% with chemotherapy
The drug also appeared effective regardless of specific genetic mutations tied to the cancer.
“This is the first RAS inhibitor evaluated in a large, randomized trial for patients with pancreatic cancer,” said Dr. Brian Wolpin. “It’s exciting to see that we may soon be able to help patients in ways we haven’t been able to before.”
Pancreatic cancer is often diagnosed at an advanced stage and has long been difficult to treat. Most patients rely on chemotherapy, which offers limited survival benefits, particularly after the disease spreads.
More than 90% of pancreatic cancers are driven by mutations in the KRAS gene. Daraxonrasib targets those mutations by blocking RAS proteins, which fuel tumor growth.
Unlike chemotherapy, the drug is taken orally once a day and does not require IV infusions.
Researchers say its ability to target multiple forms of RAS mutations could make it effective for a broad range of patients.
The study found the drug was generally well tolerated, with no unexpected safety concerns. The most common side effects included:
- Rash
- Mouth inflammation
- Nausea
- Diarrhea
The trial included 500 patients across North America, Europe, and Asia. Based on the results, researchers say daraxonrasib could become the new standard of care for second-line treatment of metastatic pancreatic cancer if approved by the FDA.
An expanded access program has already been authorized, allowing some patients to receive the drug while the approval process continues.
Researchers are also studying whether the drug could be used earlier in treatment, including as a first-line therapy.
“If approved, this would mark a dramatic shift in how pancreatic cancer is treated,” Wolpin said.
For patients facing a disease with historically limited options, the results represent a rare and meaningful step forward.
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