At the ASCO Annual Meeting, Dana-Farber’s Brian Wolpin, MD, MPH, will present positive results from the RASolute 302 trial, showing that treatment with daraxone radib, an investigational oral RAS(ON) multiselective inhibitor, significantly increases survival compared to chemotherapy in patients with previously treated metastatic pancreatic cancer, regardless of RAS mutation status.
Positive results from the pivotal randomized phase 3 RASolute 302 trial comparing daraxone lasib with chemotherapy as second-line therapy for patients with metastatic pancreatic cancer could change the way people think about and treat pancreatic cancer. Results will be presented and simultaneously presented at the plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on May 31, 2026, by Brian Wolpin, MD, MPH, Director of the Hale Family Pancreatic Cancer Research Center and Dana-Farber Cancer Institute Digestive Cancer Center. New England Medical Journal.
Dr. Wolpin will report that daraxone lasib demonstrated significant improvements in overall survival and progression-free survival compared with chemotherapy, was generally well tolerated, had a manageable safety profile, and no unexpected safety findings. These results support the use of dalaxone lasib as a new standard of care in the second-line treatment of metastatic pancreatic cancer. On May 1, 2026, the FDA granted Revolution Medicine permission to begin an expanded access program for daraxonelasib for patients with previously treated metastatic pancreatic cancer.
This is the first RAS inhibitor to be evaluated in a large randomized trial in patients with pancreatic cancer, demonstrating how these new drugs can have a significant impact on the treatment of the disease. I am very happy to know that we will soon be able to help patients with metastatic pancreatic cancer in ways that we have not been able to do before, potentially improving both survival rates and quality of life. ”
Brian Wolpin, MD, MPH, Director, Hale Family Pancreatic Cancer Research Center and Digestive Cancer Center, Dana-Farber Cancer Institute
Pancreatic cancer patients often discover their disease after it has spread. The current standard of care for most patients is chemotherapy. Few patients survive beyond 1 year, and second-line standard chemotherapy often provides modest benefit.
More than 90 percent of pancreatic cancer patients have cancer-causing mutations in the KRAS oncogene, a member of the RAS gene family. Dalaxone lasib is an oral, multiselective RAS inhibitor that is effective against RAS mutations that commonly occur in pancreatic cancer. This drug is given as a daily oral treatment without intravenous infusion.
“Given its ability to inhibit mutant and nonmutant RAS(ON) proteins, daraxone lasib has broad applicability not previously possible. This is a targeted therapy that is expected to be relevant to all patients with metastatic pancreatic cancer,” Wolpin said. “If this drug is approved by the FDA, it would represent a dramatic change in the way pancreatic cancer is treated.”
This international Phase 3 trial enrolled 500 patients with metastatic pancreatic cancer from North America, Europe, and Asia. All patients had previously been treated with one type of chemotherapy for metastatic disease. Patients were randomly assigned to receive dalaxone lasib or second-line chemotherapy.
Patients who received dalaxone lasib showed a significant improvement in overall survival compared to patients who received chemotherapy, regardless of RAS mutation status. In the overall study population, patients who received dalaxone lasib had a hazard ratio of 0.40 and median overall survival of 13.2 months compared to 6.7 months in the chemotherapy group. A reduced risk of cancer progression was also observed in these patients, with median progression-free survival of 7.2 months compared to 3.6 months in the chemotherapy group.
Among patients with known RAS G12 mutations who received daraxone radib, 33.2 percent experienced significant tumor shrinkage or disappearance, compared with 11.8 percent of patients who received chemotherapy. Objective response rates for all patients, regardless of RAS mutation status, were 31.6 percent with dalaxone lasib and 11.2 percent with chemotherapy.
No unexpected safety findings were found for daraxonelasib compared to previous reports from phase 1/2 trials. The most common side effects were rash, mouth irritation, nausea, and diarrhea.
“For many years, we have wanted to block mutant RAS to treat pancreatic cancer because KRAS mutations are so common in this disease and a major driver of pancreatic cancer growth in the lab,” Wolpin says. “These results suggest that the science has led us in a productive direction and that this first drug that broadly targets RAS is indeed an effective treatment that may benefit many pancreatic cancer patients.”
Dalaxone lasib is the first oral multiselective RAS(ON) inhibitor tested in a clinical trial for pancreatic cancer. Together with another protein, cyclophilin A, it acts as a molecular glue that blocks RAS protein signaling. The ongoing clinical trial RASolute 303 is evaluating daraxone lasib, with or without chemotherapy, as first-line treatment for patients with metastatic pancreatic cancer.
sauce:
Dana-Farber Cancer Institute
Reference magazines:
O’Reilly, E.M. Others. (2026). Daraxone lasib or chemotherapy in previously treated metastatic pancreatic cancer. New England Medical Journal. DOI: 10.1056/NEJMoa2605555. https://www.nejm.org/doi/10.1056/NEJMoa2605555
