![]() ![]() Topline results as of Septeminclude:Ħ4% ORR and 91% clinical benefit rate (complete response + partial response/unconfirmed partial response + stable disease)ĥ9% (n=41) partial responses (31 confirmed and 10 unconfirmed)Ĩ6% (n=59) of patients had a BRAF fusion alteration, for which there are no approved systemic therapies, while the remaining 14% (n=10) had a BRAF mutation The primary endpoint of the FIREFLY-1 trial is ORR by RANO criteria as assessed by Blinded Independent Central Review. In January 2023, Day One announced positive topline results from the ongoing, open-label, pivotal Phase 2 FIREFLY-1 trial evaluating tovorafenib (DAY101) as a monotherapy in relapsed or progressive pLGG. Secondary endpoints will include safety, progression-free survival, overall survival, duration of response, functional outcomes and quality of life measures. The primary endpoint will be the overall response rate (ORR) based upon Response Assessment for Neuro-Oncology (RANO) criteria as reported by Blinded Independent Central Review. The study is a randomized, monotherapy, open-label trial aiming to enroll approximately 400 patients aged 6 months to 25 years across approximately 100 sites globally, including in the United States, Europe and Asia. In March 2023, Day One dosed the first patient the pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib as a frontline therapy for patients newly diagnosed with pLGG. Given the significant unmet need for new therapies in children with relapsed or progressive pediatric low-grade gliomas, our team is laser focused on executing on our mission.” “With positive topline results from the FIREFLY-1 study and commercial launch planning well underway, we believe we are on track to submit our first New Drug Application in the first half of this year. “Day One made tremendous progress in 2022 on our mission of bringing novel targeted therapies to children with brain cancer and people of all ages with life-threatening diseases,” said Jeremy Bender, Ph.D., chief executive officer of Day One. ![]()
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