Phase 3 trial testing if oral pill can stop pancreatic cancer from returning
Study of daraxonrasib starts dosing patients after surgery, chemotherapy
Written by |
A new Phase 3 clinical trial has officially begun dosing patients to see if an experimental oral therapy can prevent the recurrence of pancreatic cancer following surgery. The study, known as RASolute 304 (NCT07252232), is testing daraxonrasib, a targeted therapy designed to block the genetic “on-switch” that drives tumor growth in the majority of pancreatic ductal adenocarcinoma (PDAC) cases, the most common form of pancreatic cancer.
The trial is expected to enroll approximately 500 participants who have already undergone surgery to remove their tumors and completed standard chemotherapy. Eligible patients must have a specific mutation in the RAS protein, a driver of cancerous cell growth found in nearly all PDAC patients. Daraxonrasib is designed to block the activity of this cancer-driving mutant protein.
Participants will be randomly assigned to either receive the daily oral therapy or undergo standard-of-care monitoring. Because the trial is open-label, both patients and their doctors will know which treatment group they are assigned to. The primary goal is to determine if daraxonrasib can significantly extend “disease-free survival,” or the length of time a patient lives without the cancer returning.
Targeting the RAS mutation
Recruitment is ongoing at sites in Ohio, South Dakota, Missouri, and Puerto Rico, with a fifth site in Connecticut expected to open soon. The trial is sponsored by Revolution Medicines, the company developing daraxonrasib.
“We are pleased to begin enrolling patients into RASolute 304, which expands the clinical evaluation of daraxonrasib into another important treatment setting for patients with RAS mutant pancreatic cancer,” Alan Sandler, MD, chief development officer of Revolution, said in a company press release.
This study is the third Phase 3 trial that Revolution has launched to test daraxonrasib in PDAC. Two other ongoing studies are targeting metastatic disease, meaning the cancer has spread to other parts of the body. The RASolute 302 (NCT06625320) is testing the therapy in patients with metastatic PDAC who previously received standard first-line treatment, while RASolute 303 is evaluating it as a first-line therapy for metastatic PDAC.
Sandler said the new trial testing daraxonrasib in patients who’ve undergone surgery “enables us to investigate daraxonrasib even earlier in the treatment paradigm, which could potentially improve the rate of long-term disease-free survival in patients with resectable pancreatic cancer.”
The U.S. Food and Drug Administration has granted daraxonrasib orphan drug and breakthrough therapy designations as a potential treatment for PDAC. Orphan drug designation provides additional incentives to companies developing treatments for rare diseases, while breakthrough therapy designation aims to expedite the development of medicines that may help address unmet medical needs.
