Day One and Servier Complete Enrollment in Phase 3 Trial for Pediatric Glioma Treatment
Day One Biopharmaceuticals, now part of Servier Group, has completed enrollment in the FIREFLY-2 clinical trial. This trial evaluates the efficacy, safety, and tolerability of tovorafenib, marketed as OJEMDA, compared to standard chemotherapy for pediatric low-grade glioma (pLGG) in patients aged 6 months to 25 years. Conducted in collaboration with the European Society for Paediatric Oncology, the trial aims to establish OJEMDA as a standard treatment for BRAF-altered pLGG. The trial involves approximately 400 participants across 140 global sites. The primary endpoint is the overall response rate, with secondary endpoints including progression-free survival and patient-reported outcomes. Preliminary results are expected in 2027. 
