Responses were observed in patients with both BRAF fusions and BRAF V600E mutations who received prior MAPK-targeted therapy.All patients with stable disease (n=6) were noted to have tumor shrinkage, ranging between 19% and 43%.14 partial responses (13 confirmed responses and 1 unconfirmed response).64% ORR and 91% CBR (partial response/unconfirmed partial response + stable disease) in the 22 RANO-evaluable patients:.Initial data from the first 25 patients enrolled in the trial demonstrate: FIREFLY-1 is being conducted in collaboration with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and is designed to support the potential regulatory approval of tovorafenib. Tovorafenib is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway. The primary endpoint of the FIREFLY-1 trial is ORR by RANO criteria as assessed by blinded independent central review. FIREFLY-1 is evaluating tovorafenib (DAY101) as once-weekly monotherapy in patients aged 6 months to 25 years with relapsed or progressive pLGG, which is the most common brain tumor diagnosed in children and for which there are no approved therapies and there is no standard of care. SOUTH SAN FRANCISCO, Calif., J(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 initial data from the first 22 Response Assessment for Neuro-Oncology (“RANO”)-evaluable patients enrolled in the ongoing, open-label, single-arm, pivotal Phase 2 FIREFLY-1 clinical trial. Topline results from the full FIREFLY-1 trial population expected in Q1 2023ĭay One plans to initiate a pivotal Phase 3 clinical trial of tovorafenib in front-line pediatric low-grade glioma (pLGG), with first patient dosed expected in Q3 2022Ĭompany to host conference call and webcast tomorrow, June 13, at 8:00 a.m. Data show an overall response rate (ORR) of 64% and clinical benefit rate (CBR) of 91% in the first 22 evaluable patients treated with monotherapy tovorafenib
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