Journal Article (Review Article)

DKFZ-2023-01160

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF.

Dummer, R. ; Flaherty, K. T. ; Robert, C. ; Arance, A. ; B de Groot, J. W. ; Garbe, C. ; Gogas, H. J. ; Gutzmer, R. ; Krajsová, I. ; Liszkay, G. ; Loquai, C. ; Mandalà, M. ; Schadendorf, D.DKFZ* ; Yamazaki, N. ; Pietro, A. d. ; Cantey-Kiser, J. ; Edwards, M. ; Ascierto, P. A.

2023
Future Medicine Ltd London

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Please use a persistent id in citations: doi:10.2217/fon-2022-1258

Abstract: Here, we summarize the 5-year results from part 1 of the COLUMBUS clinical study, which looked at the combination treatment of encorafenib plus binimetinib in people with a specific type of skin cancer called melanoma. Encorafenib (BRAFTOVI®) and binimetinib (MEKTOVI®) are medicines used to treat a type of melanoma that has a change in the BRAF gene, called advanced or metastatic BRAF V600-mutant melanoma. Participants with advanced or metastatic BRAF V600-mutant melanoma took either encorafenib plus binimetinib together (COMBO group), compared with encorafenib alone (ENCO group) or vemurafenib (ZELBORAF®) alone (VEMU group).In this 5-year update, more participants in the COMBO group were alive for longer without their disease getting worse after 5 years than those in the VEMU and ENCO groups. Patients in the COMBO group were alive for longer without their disease getting worse when they: Had less advanced cancer Were able to do more daily activities Had normal lactate dehydrogenase (LDH) levels Had fewer organs with tumors before treatment After treatment, fewer participants in the COMBO group received additional anticancer treatment than participants in the VEMU and ENCO groups. The number of participants who reported severe side effects was similar for each treatment. The side effects caused by the drugs in the COMBO group decreased over time.Overall, this 5-year update confirmed that people with BRAF V600-mutant melanoma that has spread to other parts of the body and who took encorafenib plus binimetinib were alive for longer without their disease getting worse than those who took vemurafenib or encorafenib alone. Clinical Trial Registration: NCT01909453 (ClinicalTrials.gov).

Keyword(s): BRAF V600 ; BRAF inhibitor ; COLUMBUS ; COLUMBUS part 1 ; MEK inhibitor ; binimetinib ; encorafenib ; melanoma ; plain language summary ; vemurafenib

Note: 2023 May;19(16):1091-1098

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Contributing Institute(s):

1. DKTK Koordinierungsstelle Essen/Düsseldorf (ED01)

Research Program(s):

1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2023

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Database coverage:
; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Essential Science Indicators ; IF < 5 ; JCR ; PubMed Central ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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