Day One Announces Tovorafenib FIREFLY-1 Data Published in Nature Medicine

Data subsets to be shared today in plenary oral presentations at the 2023 Society for Neuro-Oncology Annual Meeting

BRISBANE, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the publication of the registrational Phase 2 FIREFLY-1 trial results evaluating the investigational agent tovorafenib in patients with BRAF-altered, relapsed or progressive pediatric low-grade glioma (pLGG) in Nature Medicine. Subsets of the data will also be presented today in two oral plenary presentations at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada.

“The study results published in Nature Medicine demonstrate promising evidence with respect to the the impact of tovorafenib for children and young adults with BRAF-altered relapsed or progressive pLGG, a debilitating form of brain tumor that currently has no approved systemic therapies,” said Dr. Samuel Blackman, co-founder and head of research and development, Day One. “We look forward to continued development of tovorafenib.”

Details on today’s oral presentations and corresponding abstracts:

Title: *Clinical Activity and Safety of the RAF Inhibitor Tovorafenib in Patients with Optic Pathway Gliomas in the Registrational Pediatric Low-Grade Glioma Arm of the Phase 2 FIREFLY-1 (PNOC026) Study
Abstract Number: CTNI-24
Time: 10:15 – 10:25 AM PT
Location: Exhibit Hall C
Presenter: Karsten Nysom, MD, PhD, Copenhagen University Hospital - Rigshospitalet
*Presenter Karsten Nysom, MD, PhD received the 2023 SNO Annual Meeting Abstract Award for Excellence in Clinical Trials in connection to this oral presentation.

Title: Clinical Activity of RAF Inhibitor Tovorafenib According to Prior MAPK Inhibitor Treatment in the Registrational Pediatric Low-Grade Glioma Arm of the Phase 2 FIREFLY-1 (PNOC026) Study
Abstract Number: CTNI-37
Time: 10:25 – 10:35 AM PT
Location: Exhibit Hall C
Presenter: Daniel Landi, MD, Duke University

A New Drug Application for tovorafenib monotherapy in BRAF-altered relapsed or progressive pLGG is currently under priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act target action date of April 30, 2024. In addition to FIREFLY-1, the Phase 3 FIREFLY-2/LOGGIC randomized clinical trial is evaluating tovorafenib frontline therapy for patients newly diagnosed with pLGG.