Day One Announces New OJEMDA™ (tovorafenib) Data to be Presented in Oral Session at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting

Core Insights - Day One Biopharmaceuticals is set to present new data on OJEMDA (tovorafenib) demonstrating durable responses and clinical stability in pediatric low-grade glioma (pLGG) patients at the Society for Neuro-Oncology (SNO) meeting [1][3] Company Overview - Day One Biopharmaceuticals focuses on developing targeted therapies for life-threatening diseases, particularly in pediatric cancer, addressing a critical unmet need in therapeutic development [11][12] - The company is based in Brisbane, California, and aims to redefine cancer drug development for all ages [11][12] Product Information - Tovorafenib (OJEMDA) is a Type II RAF kinase inhibitor approved for treating patients aged 6 months and older with relapsed or refractory pLGG harboring BRAF alterations [4][6] - The drug has received Breakthrough Therapy and Rare Pediatric Disease designations from the FDA, indicating its potential significance in treating pLGG [6] Clinical Trial Insights - The pivotal Phase 2 FIREFLY-1 trial evaluated tovorafenib in 137 patients, showing an overall response rate (ORR) of 67% and a median duration of response (DOR) of 16.6 months [8] - The trial results indicate sustained efficacy and long-term response in patients, reinforcing the clinical evidence for OJEMDA's differentiated profile [3][8] Pediatric Low-Grade Glioma Context - Pediatric low-grade glioma is the most common brain tumor in children, with significant incidence rates in the US and Europe, and BRAF alterations are present in over 50% of cases [9] - The condition often requires long-term treatment due to its chronic nature and the profound side effects associated with both the tumor and its treatment [9]