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PubMed · 42501621

primary analysis of the RANDOMIZED eortc-2139/columbus-ad trial: Adjuvant encorafenib and binimetinib versus placebo in high-risk stage II BRAF-V600E/K melanoma.

Alexander Cj van Akkooi·Michal Kicinski·Anne-Sophie Govaerts·Axel Hauschild·Piotr Rutkowski·Petr Arenberger·Paolo A Ascierto·Piotr Tomczak·Gaëlle Quereux·Federica De Galitiis·Caroline Dutriaux·Christoffer Gebhardt·Ellen Kapiteijn·Laurent Machet·Miguel Ga Berciano·Michele Del Vecchio·Mathilde Jalving·Thomas Jouary·Ivana Krajsova·Suzana Matkovic·Barbara Merelli·Laurent Mortier·Pages-LaurentCecile Pagès-Laurent·Giuseppe Palmieri·Marc Pracht·Yvetta Vantuchova·Daniela Massi·Nathalie Elaut·Gaetan de Schaetzen·Sarah Nuyens·Nitish Jha·Isabelle Klauck·Benoît Sansas·Jean Claude Vedovato·Paul C Lorigan·Georgina V Long·Alexander Mm Eggermont·Mario Mandala
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Abstract

PURPOSE: Stage IIB/IIC melanoma has a high risk of recurrence after resection. Combined BRAF/MEK inhibitor therapy showed benefit in resected high-risk stage III and advanced melanoma. The objective of this study was to investigate its role in stage IIB/IIC. METHODS: Adult patients with resected stage IIB/IIC cutaneous melanoma which had a BRAF V600E/K mutation were randomized 1:1 to receive encorafenib (enco) 450 mg QD + binimetinib (bini) 45 mg BID orally for one year or placebo. The study planned to randomize 815 patients and was designed to demonstrate superiority regarding recurrence-free survival (RFS). Following a premature termination of accrual, the study was amended with safety as the primary endpoint and RFS as secondary endpoint. RESULTS: Between June 9, 2022, and October 9, 2023, 339 patients were screened for a BRAF mutation and 110 randomized. Data cutoff was 19 Nov. 2024, after the last patient discontinued study participation. Among randomized patients, 87 (79%) had a BRAF V600E mutation, and 39 (35%) AJCC8 stage IIC. Median follow-up was 12 and 7 months for enco/bini and placebo arms, respectively. Among 54 patients who initiated enco + bini, grade ≥ 3 treatment-related adverse events (AE) occurred in 13 (24%) patients, and 18 (33%) patients had an AE leading to permanent treatment discontinuation. RFS at 12 months was 86% (95% CI: 65-95%) in the enco + bini and 70% (95% CI: 46-85%) in the placebo arm, distant metastasis-free survival at 12 months was 92% (95% CI: 77-97%) for enco + bini and 82% (95% CI: 55-93%) for placebo. CONCLUSION: EORTC 2139 - Columbus-AD demonstrated a consistent and manageable safety profile and encouraging efficacy results for the combination of enco and bini in resected stage IIB/C BRAF V600E/K-mutated cutaneous melanomas.

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AdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarbamatesChemotherapy, AdjuvantCutaneous Malignant MelanomaDouble-Blind MethodMelanomaMutationNeoplasm StagingProto-Oncogene Proteins B-rafSkin NeoplasmsSulfonamidesAdjuvantBRAFBinimetinibEncorafenibMEKStage II MelanomaJournal ArticleRandomized Controlled TrialMulticenter StudyClinical Trial, Phase IIIEquivalence Trial

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Alexander Cj van Akkooi, Michal Kicinski, Anne-Sophie Govaerts, Axel Hauschild, Piotr Rutkowski, Petr Arenberger, Paolo A Ascierto, Piotr Tomczak, Gaëlle Quereux, Federica De Galitiis, Caroline Dutriaux, Christoffer Gebhardt, Ellen Kapiteijn, Laurent Machet, Miguel Ga Berciano, Michele Del Vecchio, Mathilde Jalving, Thomas Jouary, Ivana Krajsova, Suzana Matkovic, Barbara Merelli, Laurent Mortier, Pages-LaurentCecile Pagès-Laurent, Giuseppe Palmieri, Marc Pracht, Yvetta Vantuchova, Daniela Massi, Nathalie Elaut, Gaetan de Schaetzen, Sarah Nuyens, Nitish Jha, Isabelle Klauck, Benoît Sansas, Jean Claude Vedovato, Paul C Lorigan, Georgina V Long, Alexander Mm Eggermont, Mario Mandala. 2026-07-21. primary analysis of the RANDOMIZED eortc-2139/columbus-ad trial: Adjuvant encorafenib and binimetinib versus placebo in high-risk stage II BRAF-V600E/K melanoma.. https://doi.org/10.1016/j.ejca.2026.116951

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Adult subjectAged subjectAged, 80 and over subjectAntineoplastic Combined Chemotherapy Protocols subjectClinical Trial, Phase III subjectDouble-Blind Method subjectEquivalence Trial subjectFemale subjectHumans subjectJournal Article subjectMale subjectMiddle Aged subjectMulticenter Study subjectMutation subjectRandomized controlled trials study

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