Day One Biopharmaceuticals, now part of Servier Group, has completed enrollment in the FIREFLY-2 clinical trial evaluating tovorafenib versus standard chemotherapy as a front-line treatment for pediatric low-grade glioma (pLGG). The trial enrolled approximately 400 participants aged 6 months to 25 years with low-grade glioma across roughly 140 sites globally.
The Phase 3, randomized, open-label study is being conducted in collaboration with the European Society for Paediatric Oncology Brain Tumor Group LOGGIC Consortium. Participants are receiving either once-weekly tovorafenib, an oral Type II RAF inhibitor, or one of four standard of care chemotherapy regimens. The trial specifically targets patients with RAF-altered pLGG requiring first-line systemic therapy.
Tovorafenib is currently marketed as OJEMDA and is indicated for patients 6 months and older with relapsed or refractory pediatric LGG harboring a BRAF fusion, rearrangement, or BRAF V600 mutation. "Reaching full enrollment in this trial is a critical step toward our goal of establishing OJEMDA as standard of care across all lines of therapy for individuals with BRAF-altered pLGG," said Dr. Elly Barry, Chief Medical Officer at Day One.
The primary endpoint is overall response rate, including duration of response, based on RAPNO-LGG criteria. Key secondary endpoints include progression-free survival, event-free survival, time to next treatment, overall survival, and patient-reported outcomes. The primary analysis is expected approximately 12 months after the last patient enrollment, with preliminary insights anticipated in 2027.
The completion occurred just over three years after trial initiation and shortly after Servier's acquisition of Day One. "Completing enrollment in FIREFLY-2 is a powerful early signal of momentum," said David K. Lee, CEO of Servier Pharmaceuticals, noting the milestone reinforces the strategic decision to join forces.
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