CHICAGO -- RASolute 302 trial results were hailed as a game-changing breakthrough in the treatment of pancreatic cancer.
The phase III study showed that second-line daraxonrasib, an investigational oral RAS(ON) multi-selective inhibitor, doubled overall survival (OS) and progression-free survival (PFS) in patients with previously treated metastatic pancreatic ductal adenocarcinoma.
In the primary endpoint population of patients with RAS G12 mutations, median OS reached 13.2 months with daraxonrasib versus 6.6 months with investigator's choice of chemotherapy (HR 0.40, 95% CI 0.30-0.54, P<0.001), reported Brian Wolpin, MD, MPH, of the Dana-Farber Cancer Institute in Boston.
PFS (the second primary endpoint) reached a median 7.3 months with daraxonrasib versus 3.5 months with chemotherapy (HR 0.45, 95% CI 0.34-0.59, P<0.001), according to findings detailed at the American Society of Clinical Oncology (ASCO) annual meeting and published simultaneously in the New England Journal of Medicine.
"These results support daraxonrasib as the new standard of care for patients with previously treated metastatic pancreatic cancer," Wolpin said at a press briefing.
