Experimental Drug Nearly Doubles Survival in Pancreatic Cancer

A Phase III clinical trial has demonstrated that the experimental drug daraxonrasib nearly doubled survival time for patients with advanced pancreatic cancer, marking the first therapy to show a substantial advantage over chemotherapy in this deadly disease. Patients taking the daily pill survived for a median of 13.2 months compared to 6.7 months for those receiving standard chemotherapy, according to the study published Sunday in the New England Journal of Medicine and presented at the American Society for Clinical Oncology meeting in Chicago. The drug, developed by Revolution Medicines, works by blocking mutated KRAS proteins that drive tumor growth in more than 90 percent of pancreatic cancer cases, a target that had been considered "undruggable" for decades due to its molecular structure. The trial enrolled 500 patients whose metastatic pancreatic cancer had stopped responding to prior treatment. Those receiving daraxonrasib reported less pain and a better quality of life compared to chemotherapy recipients, with many patients still using the drug after the data was analyzed. Dr. Brian Wolpin of the Dana-Farber Cancer Institute, who presented the findings, said the drug should become "a new standard of care" for previously treated metastatic pancreatic cancer, while Dr. Zev Wainberg of UCLA, who helped lead the study, noted that it represents a major breakthrough despite not being a cure. The Food and Drug Administration has granted the drug breakthrough designation and plans an expedited review, with an expanded access program already allowing some U.S. patients to receive the treatment. Side effects most commonly included a rash that can become severe and mouth sores. Pancreatic cancer is among the deadliest forms of cancer, with the American Cancer Society estimating approximately 67,000 new cases will be diagnosed in the U.S. this year and more than 52,000 deaths. The five-year survival rate stands at just 13 percent, largely because the disease is typically detected only after it has spread to other organs. The drug uses a molecular glue mechanism to bind with multiple KRAS subtypes, and researchers now plan to explore whether it can be used earlier in treatment or in combination with chemotherapy. The Hospital Clínic de Barcelona participated in the international trial, with the drug likely taking 18 months to two years to reach European patients pending regulatory approval.