TY - JOUR
AU - Dummer, Reinhard
AU - Flaherty, Keith T
AU - Robert, Caroline
AU - Arance, Ana
AU - B de Groot, Jan Willem
AU - Garbe, Claus
AU - Gogas, Helen J
AU - Gutzmer, Ralf
AU - Krajsová, Ivana
AU - Liszkay, Gabriella
AU - Loquai, Carmen
AU - Mandalà, Mario
AU - Schadendorf, Dirk
AU - Yamazaki, Naoya
AU - Pietro, Alessandra di
AU - Cantey-Kiser, Jean
AU - Edwards, Michelle
AU - Ascierto, Paolo A
TI - COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF.
JO - Future oncology
VL - 19
IS - 16
SN - 1479-6694
CY - London
PB - Future Medicine Ltd
M1 - DKFZ-2023-01160
SP - 1091-1098
PY - 2023
N1 - 2023 May;19(16):1091-1098
AB - 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).
KW - BRAF V600 (Other)
KW - BRAF inhibitor (Other)
KW - COLUMBUS (Other)
KW - COLUMBUS part 1 (Other)
KW - MEK inhibitor (Other)
KW - binimetinib (Other)
KW - encorafenib (Other)
KW - melanoma (Other)
KW - plain language summary (Other)
KW - vemurafenib (Other)
LB - PUB:(DE-HGF)16
C6 - pmid:37309702
DO - DOI:10.2217/fon-2022-1258
UR - https://inrepo02.dkfz.de/record/276785
ER -