Encorafenib plus binimetinib in patients with BRAF-mutated melanoma brain metastases: Results from the BECARE (GEM-2002) trial

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ID: 329374
2026
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Abstract
Abstract Background Encorafenib plus binimetinib (EB) is a standard treatment for BRAFV600-mutated melanoma brain metastasis (MBM). However, there is limited evidence of EB use in MBM from clinical trials, and real-world data are scarce. This study aimed to determine the effectiveness and safety of EB in BRAFV600-mutated MBM. Methods BECARE-GEM-2002 was a retrospective study conducted in 24 hospitals in Spain, including patients treated according to standard clinical practice with EB as the 1st line or 2nd line of treatment after progression to immunotherapy, regardless of symptoms and corticosteroid use. Patients had measurable intracranial disease (≥5 mm on CT scan). Previous treatment with BRAF/MEK inhibitors was not allowed. Results Between 2021-2025, 60 patients were included, 52 (86.7%) treated upfront and 8 (13.3%) after ICIs progression. The ORR was 58.3% (95% confidence interval [CI]: 44.9-70.9), 65.4% (95% CI: 44.3-82.8) in asymptomatic and 52.9% (95% CI: 35.1-70.2) in symptomatic MBM. Radiotherapy (RT) was administered prior to EB in seven patients (11.7%) and concurrently in 17 (28.3%). Patients receiving RT showed an ORR of 76% (95% CI: 54.9-90.6). The median PFS was 7.4 months (95% CI: 6.2-9.7) and median OS was 10.6 months (95% CI: 9.2-15.0). Treatment-related adverse events of grade ≥3 were reported in 12 patients (20%), the most frequent being transaminitis (6.7%) and gastrointestinal haemorrhage (3.3%). Conclusions EB was safely administered in the real-world and showed clinically significant benefit in patients with BRAFV600-mutant MBM, regardless of brain symptoms. The potential role of RT should be explored in prospective trials.
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Authors Pablo Cerezuela, Miguel-Ángel Berciano-Guerrero, E. Muñoz-Couselo, Pedro Sánchez Mauriño, Regina García Galindo, Lourdes Gutiérrez Sanz, José Balsalobre Yago, Teresa Puértolas, Carlos Aguado, Silvia Sequero, Guillermo Crespo, Cristina Aguayo, Enrique Espinosa, Pedro López, Rafael López Castro, Joaquín Fra Rodríguez, Gretel Benítez, Alberto Jacobo Cunquero-Tomás, Alfonso Berrocal, Ainara Soria
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Journal Neuro-Oncology Advances
Year 2026
DOI
10.1093/noajnl/vdag252
URL
https://doi.org/10.1093/noajnl/vdag252
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