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Association details:
Biomarker:BRAF V600E
Cancer:Glioma
Drug:Ojemda (tovorafenib) (pan-RAF inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Clinical activity of pan-RAF inhibitor tovorafenib in the registrational pediatric low-grade glioma arm of the phase 2 FIREFLY-1 (PNOC026) study.

Published date:
05/25/2023
Excerpt:
Per independent assessment in 69 RANO-evaluable patients, ORR was 64%, [3 CR, 41 PR (10 unconfirmed) and 19 SD] with a clinical benefit rate of 91%. Responses were achieved in tumors with BRAF fusions and V600E mutations, including those previously treated with MAPK inhibitors....Tovorafenib was generally well tolerated and showed encouraging evidence of antitumor activity in children and young adults with recurrent/progressive BRAF-altered pLGG.
DOI:
10.1200/JCO.2023.41.16_suppl.10004
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Day One Announces Positive Initial Data from Pivotal FIREFLY-1 Trial of Tovorafenib (DAY101) in Relapsed Pediatric Low-Grade Glioma

Published date:
06/12/2022
Excerpt:
Day One Biopharmaceuticals...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….FIREFLY-1 is evaluating tovorafenib (DAY101) as once-weekly monotherapy in patients aged 6 months to 25 years with relapsed or progressive pLGG....Initial data from the first 25 patients enrolled in the trial demonstrate...64% ORR and 91% CBR (partial response/unconfirmed partial response + stable disease) in the 22 RANO-evaluable patients...14 partial responses (13 confirmed responses and 1 unconfirmed response)...6 patients with stable disease....Responses were observed in patients with both BRAF fusions and BRAF V600E mutations who received prior MAPK-targeted therapy...
Trial ID: