Revolution Medicines received Breakthrough Therapy Designation from the FDA for daraxonrasib, its RAS(ON) inhibitor, targeting previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) patients with KRAS G12 mutations. This designation stems from positive Phase 1 clinical trial data. The company expects to complete enrollment for its Phase 3 RASolute 302 trial, evaluating daraxonrasib in the same patient population, later this year, with results anticipated in 2026.
This Breakthrough Therapy Designation is significant because PDAC carries a dismal prognosis, with a five-year survival rate around 3% for metastatic cases. Currently, there are limited effective treatment options for patients with advanced PDAC, especially those with KRAS G12 mutations, which are present in the majority of PDAC tumors. The potential of daraxonrasib to improve outcomes for these patients represents a critical advancement in the field.
The Phase 3 RASolute 302 trial will assess daraxonrasib’s efficacy in a core group of patients with RAS G12X mutations and an expanded group including patients with other RAS mutations or no identified targetable mutation. The trial’s primary endpoints are progression-free survival and overall survival in the core population. This structure allows for a focused evaluation of the drug’s performance in the most prevalent mutation subtype while also exploring its broader applicability.
This FDA designation validates the promise of daraxonrasib as a potential new therapy for a notoriously difficult-to-treat cancer. Positive Phase 3 results could lead to accelerated regulatory review and approval, bringing a much-needed treatment option to patients with metastatic PDAC. This could also significantly impact the landscape of pancreatic cancer treatment and potentially pave the way for the development of other targeted therapies for RAS-driven cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
