Day One Biopharmaceuticals, Inc. released three-year follow-up data from the OJEMDA pivotal Phase 2 FIREFLY-1 trial.
The data showed that patients on tovorafenib could spend significant time off therapy with the option to retreat as needed.
Primary trial results and new data were presented at the Society for Neuro-Oncology Annual Meeting.
Treatment Continuity
77% of patients on OJEMDA remained off therapy for at least 12 months following treatment.
Time to Next Treatment
The median time to next treatment after starting OJEMDA exceeded 3.5 years.
Efficacy Results
Majority of patients completed 26 or more cycles of treatment with an overall response rate of 53%.
- The data highlights the potential for tovorafenib to become the second-line standard of care in pediatric low-grade glioma.
- Patients showed disease control during extended periods off therapy, with minimal tumor rebound within the first 6 months.
- No new safety signals were identified in the three-year analysis.
The three-year follow-up data demonstrates the effectiveness and safety of tovorafenib in treating pediatric low-grade glioma, offering patients meaningful time off therapy while maintaining disease control.