Revolution Medicines has begun enrolling patients in RASolute 305, a global Phase 3 clinical trial evaluating zoldonrasib in combination with standard-of-care chemotherapy as a first-line treatment for metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC), according to a company statement.
The trial (NCT07621718) is a randomized, double-blind, placebo-controlled study comparing zoldonrasib plus investigator’s choice of chemotherapy against placebo plus chemotherapy in previously untreated patients. Chemotherapy options include modified FOLFIRINOX or gemcitabine plus nab-paclitaxel. The primary endpoints are progression-free survival and overall survival.
Zoldonrasib is an oral RAS(ON) G12D-selective covalent inhibitor. RAS G12D is the most prevalent RAS mutation subtype in PDAC, occurring in approximately 40% of patients. Metastatic PDAC carries a five-year survival rate of approximately 3%, according to cited data from the American Cancer Society.
RASolute 305 runs alongside RASolute 303, a separate ongoing Phase 3 trial evaluating daraxonrasib, Revolution Medicines’ RAS(ON) multi-selective inhibitor, in first-line pancreatic cancer.
"RAS G12D, the most common RAS subtype in pancreatic cancer, is associated with particularly poor clinical outcomes," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "Early studies of zoldonrasib have demonstrated encouraging clinical activity and safety."
Approximately 60,000 people are diagnosed with pancreatic cancer annually in the U.S., and about 50,000 deaths are attributed to the disease each year. More than 90% of PDAC tumors harbor RAS mutations. No targeted therapy is currently approved for RAS G12D cancers, according to the company.
Revolution Medicines (RVMD) is based in Redwood City, Calif.
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