Day One Announces Topline Data from Pivotal Phase 2 FIREFLY-1 Trial Demonstrating Meaningful Responses with Tovorafenib (DAY101) in Recurrent or Progressive Pediatric Low-Grade Glioma
- Overall response rate (ORR) of 64% and clinical benefit rate (CBR) of 91% in 69 heavily-pretreated, RANO-evaluable patients
- Median duration of 8.4 months on therapy as of September 28, 2022, with 77% of patients remaining on treatment
- Additional data to be presented at a medical meeting in the second quarter of 2023
- New Drug Application submission planned for first half of 2023