Conducting rigorous clinical trials with renowned collaborators

FIREFLY-1 is a pivotal Phase 2, multicenter, open-label study designed to evaluate the safety and efficacy of tovorafenib in patients aged 6 months to 25 years with relapsed or progressive low-grade glioma harboring a known activating BRAF alteration. The study aims to enroll approximately 60 patients. The primary endpoint will be overall response rate (ORR), defined as the proportion of patients with best overall confirmed response rate based upon Response Assessment for Neuro-Oncology (RANO) criteria. Secondary and exploratory endpoints include the overall response rate based on Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria and volumetric analyses, event free survival, safety, functional outcomes, and quality of life measures.

Additional information about FIREFLY-1 may be found at ClinicalTrials.gov, using Identifier NCT04775485.

FIRELIGHT-1 is a multi-center, open-label umbrella master study designed to evaluate the safety and efficacy of tovorafenib in patients with recurrent or progressive solid tumors with activating RAF alterations. This study will accrue adults as well as adolescent patients as young as 12 years of age. In the Phase 2 monotherapy portion (sub-study 1), patients will be enrolled either into a melanoma cohort or a “tissue agnostic” cohort. The study also includes a Phase 1b combination (sub-study 2) portion of tovorafenib with the Day One’s investigational oral MEK inhibitor, pimasertib. The primary endpoint will be overall response rate (ORR) as assessed by RECIST version 1.1 criteria. Secondary and exploratory endpoints include safety, duration of response, progression-free survival, and time to response.

Additional information about FIRELIGHT-1 may be found at ClinicalTrials.gov, using Identifier NCT04985604.