Revolution Medicines has received a positive CHMP opinion recommending marketing authorisation for RASONQUE (daraxonrasib) as a once-daily oral monotherapy for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
If approved by the EC, it would become the first broad RAS-targeted treatment option available in the EU for this patient group.
Mark A. Goldsmith said: “Today’s positive CHMP opinion marks a major step toward making RASONQUE available to eligible adults with metastatic pancreatic cancer in the European Union.”
He added: “RASONQUE is an oral medicine designed to address RAS, the key driver of pancreatic cancer, and unprecedented results from the Phase 3 RASolute 302 trial demonstrated its potential to benefit patients with this devastating disease.”
The phase 3 RASolute 302 trial compared RASONQUE with investigator’s choice of cytotoxic chemotherapy in previously treated metastatic PDAC. The study met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat population.
In the intent-to-treat population, RASONQUE reduced the risk of death by 60% compared with chemotherapy, with a hazard ratio of 0.40. Median overall survival reached 13.2 months with RASONQUE versus 6.7 months for chemotherapy.
RASONQUE also delivered significant improvements in progression-free survival, with a hazard ratio of 0.49. Median progression-free survival was 7.2 months with RASONQUE compared to 3.6 months with chemotherapy. A subsequent ad hoc analysis showed median overall survival of 12.4 months with RASONQUE versus 6.7 months for chemotherapy, consistent with the primary analysis.
The most common adverse reactions included diarrhea, dermatitis acneiform, stomatitis, nausea, vomiting and fatigue. Once granted, the centralized EC authorisation will apply across all EU member states and EEA countries Iceland, Norway and Liechtenstein.
