PHILADELPHIA, PA — Fore Biotherapeutics will continue its FORTE study of plixorafenib as planned after an independent monitoring committee cleared the first interim efficacy analysis of its BRAF fusion cohort, keeping the cancer drug program on track for topline results in the second half of 2027.
The Independent Data Monitoring Committee conducted the pre-specified analysis after the first 25 participants in the BRAF fusion basket had sufficient data for response assessment. The review evaluated plixorafenib against a defined efficacy threshold while continuing safety oversight.
A second interim efficacy analysis is expected after sufficient data are available from 50 participants. Fore plans to evaluate the primary endpoint of overall response rate, supported by duration of response, in approximately 75 patients.
The study is evaluating plixorafenib as a monotherapy in patients with advanced solid tumors carrying BRAF fusions, including recurrent or progressive primary central nervous system tumors with the alteration.
Fore said a positive primary analysis could potentially support submission of a New Drug Application to the U.S. Food and Drug Administration under the Accelerated Approval pathway.
“The passing of this first protocol-specified interim analysis for the BRAF fusion basket, and the second successful interim analysis in the FORTE study, is an important milestone and supports that tumor regressions continue to be observed, along with long duration of treatment,” Chief Medical Officer Stacie Peacock Shepherd said.
The company estimates BRAF fusions occur in about 1% of solid tumors and affect approximately 33,000 patients. Fore said there are no approved treatments for the vast majority of those patients.
Plixorafenib is an oral BRAF inhibitor designed to prevent MAPK activation through a dimer and paradox breaker mechanism. Fore is studying the drug across BRAF V600E central nervous system tumors, BRAF fusions and rare BRAF V600E solid tumors.
The latest review marks the second interim analysis passed by the FORTE program. An earlier analysis covered patients with BRAF V600E CNS tumors.
Fore expects topline results from that CNS cohort around the end of 2026 and plans to submit an NDA for treatment of BRAF V600E CNS tumors during the first half of 2027. Results from the BRAF fusion cohort are expected in the second half of 2027.
Earlier Phase 1/2a results provide supporting data for the BRAF fusion program. Among 14 adults with advanced solid tumors carrying BRAF fusions, plixorafenib produced a 14% overall response rate, including one complete response and one partial response.
Seven additional patients, or 50%, had stable disease, producing a 64% disease control rate. The two responding patients have remained on treatment under single-patient investigational new drug protocols for more than eight years and four years, respectively.
Across 113 participants, Grade 3 or higher adverse events attributed to plixorafenib occurred in fewer than 10%, according to Fore. Treatment discontinuations for drug-related adverse events were below 2%, and no related skin events resulted in dose reductions, interruptions or discontinuations.
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