The most common side effects reported related to tovorafenib were change in hair color (75%), increased creatine phosphokinase (64%), anemia (46%), fatigue (42%) and maculopapular rash (42%). Safety data, based on 77 treated patients, indicated monotherapy tovorafenib to be generally well-tolerated. 86% (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.28% (n=19) patients with stable disease.59% (n=41) partial responses (31 confirmed and 10 unconfirmed).64% ORR and 91% clinical benefit rate (complete response + partial response/unconfirmed partial response + stable disease).
#DAY ONE BIOPHARMACEUTICALS TRIAL#
The primary endpoint of the FIREFLY-1 trial is overall response rate (ORR) by Response Assessment for Neuro-Oncology (RANO) criteria as assessed by blinded independent central review. Additional data will be submitted for presentation at an upcoming medical meeting in the second quarter of 2023. Pediatric low-grade glioma is the most common brain tumor diagnosed in children and for which there is no standard of care, and for which there are no approved therapies for the majority of patients.
08, 2023 (GLOBE NEWSWIRE) - Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced positive topline results from the ongoing, open-label, pivotal Phase 2 FIREFLY-1 trial evaluating the investigational agent, tovorafenib (DAY101), as a monotherapy in recurrent or progressive pediatric low-grade glioma (pLGG).
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