Revolution Medicines Introduces Breakthrough RASONQUE Therapy for Treating Metastatic Pancreatic Cancer
Revolution Medicines has introduced RASONQUE (daraxonrasib) in combination with chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC), a common form of pancreatic cancer that can spread to other parts of the body.
RASONQUE is an oral RAS(ON) multi-selective inhibitor designed to block active RAS proteins involved in cancer cell growth and survival. The therapy is being evaluated in combination with GnP, a chemotherapy regimen commonly used to treat patients with pancreatic cancer. RASONQUE has already been approved by the FDA for adults with metastatic PDAC who have received at least one prior systemic treatment or who are not candidates for multiagent systemic therapy.
The designation is supported by preliminary results from the open-label, multicentre Phase 1/2 RMC-GI-102 trial. The study evaluated RASONQUE in combination with GnP in patients with previously untreated metastatic PDAC with RAS mutations. The combination showed preliminary anti-tumour activity and a manageable safety profile that was consistent with the known safety profiles of RASONQUE and GnP.
Pancreatic adenocarcinoma is the most common form of pancreatic cancer and is often diagnosed after the disease has spread. Approximately 80% of patients are diagnosed after the cancer has become advanced, when treatment options are more limited. Metastatic PDAC has a five-year relative survival rate of approximately 3% in the U.S.
The FDA’s Breakthrough Therapy designation is intended to accelerate the development and review of medicines for serious conditions where preliminary clinical evidence indicates the potential for substantial improvement over available treatments. The designation provides additional interaction with the FDA during the development process.
RASONQUE is being developed as an oral treatment for RAS-driven cancers. The therapy is also being evaluated in a global Phase 3 programme for patients with metastatic RAS-mutant non-small cell lung cancer (NSCLC). The use of RASONQUE with chemotherapy in patients with previously untreated metastatic PDAC remains investigational, and its safety and efficacy in this setting have not yet been established.
