A new experimental drug for metastatic pancreatic cancer nearly doubled overall survival in a pivotal Phase 3 clinical trial conducted at the Dana-Farber Cancer Institute, potentially setting a new standard for patients whose disease has progressed after initial chemotherapy.
The drug, daraxonrasib, helped patients live a median of 13.2 months compared to 6.7 months for those treated with second-line chemotherapy. The treatment also cut the risk of death by 60 percent, according to results from the global RASolute 302 trial that will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.
The study enrolled 500 patients across North America, Europe, and Asia. All participants had metastatic pancreatic cancer and had already received one line of chemotherapy for advanced disease before being randomized to receive either daraxonrasib or chemotherapy.
Researchers also reported that the drug delayed disease progression. Median progression-free survival reached 7.2 months in the daraxonrasib group, compared with 3.6 months among patients receiving chemotherapy.
Pancreatic cancer remains one of the deadliest forms of cancer, largely because it is often diagnosed after it has spread. Current second-line treatment options offer limited benefit, and few patients with metastatic disease survive beyond a year.
More than 90 percent of pancreatic cancers carry mutations in the KRAS oncogene, making RAS proteins an attractive target for drug developers. Daraxonrasib is an oral RAS(ON) multi-selective inhibitor designed to block signaling from both mutant and non-mutant RAS proteins.
“This is the first RAS inhibitor evaluated in a large, randomized trial for patients with pancreatic cancer, and it demonstrates how important an impact these novel medicines are likely to have on the treatment of the disease,” said Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research and Gastrointestinal Cancer Center at Dana-Farber Cancer Institute.
According to investigators, the survival benefit was observed regardless of a patient’s RAS mutation status, suggesting the treatment could have broad applicability across metastatic pancreatic cancer populations.
The trial also showed higher tumor response rates with the experimental drug. Among patients with known RAS G12 mutations, 33.2 percent experienced significant tumor shrinkage or disappearance, compared with 11.8 percent in the chemotherapy group.
Across all patients, regardless of mutation status, the objective response rate reached 31.6 percent with daraxonrasib versus 11.2 percent with chemotherapy.
Researchers reported no unexpected safety concerns. The most commonly observed side effects included rash, mouth inflammation, nausea, and diarrhea, consistent with earlier-stage clinical studies.
“Given its ability to inhibit mutant and non-mutant RAS(ON) proteins, daraxonrasib has a broad applicability that has not been possible before,” Wolpin said.
The findings could reshape treatment approaches if regulators approve the drug. Earlier this month, the US Food and Drug Administration authorized an expanded access program, allowing certain previously treated metastatic pancreatic cancer patients to receive daraxonrasib while regulatory review continues.
The study was published in The New England Journal of Medicine.
With over a decade-long career in journalism, Neetika Walter has worked with The Economic Times, ANI, and Hindustan Times, covering politics, business, technology, and the clean energy sector. Passionate about contemporary culture, books, poetry, and storytelling, she brings depth and insight to her writing. When she isn’t chasing stories, she’s likely lost in a book or enjoying the company of her dogs.
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