An experimental targeted therapy for advanced pancreatic cancer has produced survival gains that oncologists say could fundamentally change care for a disease long resistant to major progress. Daraxonrasib, developed by Revolution Medicines, doubled overall survival in a late-stage trial and this week published encouraging earlier-phase data in the New England Journal of Medicine, prompting the U.S. Food and Drug Administration to fast-track the drug and authorize its use for patients outside trials through an expanded access program.
The NEJM paper reports results from a Phase 1/2 trial of 168 patients whose pancreatic cancer had already spread beyond the pancreas and who had previously received standard chemotherapy. Patients given the highest tolerated dose of daraxonrasib experienced a median progression‑free survival of about 8.1 months and a median overall survival of roughly 15.6 months. By contrast, many patients with metastatic pancreatic cancer typically live less than a year after diagnosis with existing treatments.
Daraxonrasib works by disabling the RAS protein, a long-sought target in cancer therapy. Mutations that lock RAS into an “on” position are present in more than 90% of pancreatic tumors. The drug exploits cyclophilin A as a partner to act like a molecular glue that binds and blocks RAS—an approach that bypasses decades of failed attempts to drug the protein directly. “This really feels like a watershed moment,” said Dr. Brian Wolpin of Dana‑Farber Cancer Institute, who led the study.
Side effects were common but generally manageable, the study found. Patients experienced a blistering, sunburn-like rash, mouth and throat sores, and gastrointestinal symptoms such as vomiting and diarrhea. About 30% of patients had severe adverse events, and eight participants discontinued treatment because of toxicity. Clinicians treated most reactions with antibiotics, topical creams and anti‑diarrheal medications; some patients required brief treatment interruptions to let rashes subside.
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Earlier, interim Phase 3 results released by Revolution Medicines showed similarly large survival differences: median overall survival was 6.7 months for patients who received chemotherapy alone versus 13.2 months for those who received daraxonrasib plus chemotherapy. That trial reportedly included patients without KRAS mutations as well, raising the possibility that the therapy may benefit a broader population of pancreatic cancer patients. The full Phase 3 data are scheduled to be presented at the American Society of Clinical Oncology’s annual meeting later this month.
Clinicians not involved in the trials called the findings significant. “This drug is the most exciting thing in pancreas cancer in over a decade,” said Dr. Reza Nazemzadeh, a gastrointestinal medical oncologist at Atrium Health Levine Cancer. Dr. Sekhar Padmanabhan of Vanderbilt University Medical Center said the therapy “is going to have a significant impact” on treatment decisions. Former U.S. senator Ben Sasse, a participant in a clinical trial, has publicly described severe rashes but also substantial tumor shrinkage.
Researchers are already exploring daraxonrasib beyond second‑line use: two smaller studies presented at an American Association for Cancer Research meeting in April suggested survival benefits when the drug is used as part of first‑line therapy, and investigators are testing its activity in other RAS‑mutated cancers such as colorectal and lung cancer. Dr. Dae Won Kim of Moffitt Cancer Center said he expects the FDA to move quickly toward approval.
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Pancreatic cancer kills more than 52,000 Americans annually and is typically detected late; the American Cancer Society estimates about 67,000 new U.S. cases this year and a five‑year survival rate of only about 3% for metastatic disease. While daraxonrasib’s safety profile and longer‑term effects will need continued monitoring, the data released so far have generated rare optimism that a drug may finally alter the bleak trajectory of advanced pancreatic cancer.
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