COLUMBUS 5-Year Update: A Randomized, Open-Label, Phase III Trial of Encorafenib Plus Binimetinib Versus Vemurafenib or Encorafenib in Patients With


Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333

Informations de publication

Date de publication:
20 12 2022
Historique:
pubmed: 22 7 2022
medline: 20 12 2022
entrez: 21 7 2022
Statut: ppublish

Résumé

Combination treatment with BRAF and MEK inhibitors has demonstrated benefits on progression-free survival (PFS) and overall survival (OS) and is a standard of care for the treatment of advanced Patients with locally advanced unresectable or metastatic Five hundred seventy-seven patients were randomly assigned: 192 to encorafenib plus binimetinib, 191 to vemurafenib, and 194 to encorafenib. The 5-year PFS and OS rates with encorafenib plus binimetinib were 23% and 35% overall and 31% and 45% in those with normal lactate dehydrogenase levels, respectively. In comparison, the 5-year PFS and OS rates with vemurafenib were 10% and 21% overall and 12% and 28% in those with normal lactate dehydrogenase levels, respectively. The median duration of response with encorafenib plus binimetinib was 18.6 months, with disease control achieved in 92.2% of patients. In comparison, the median duration of response with vemurafenib was 12.3 months, with disease control achieved in 81.2% of patients. Long-term follow-up showed no new safety concerns, and results were consistent with the known tolerability profile of encorafenib plus binimetinib. Interactive visualization of the data presented in this article is available at COLUMBUS dashboard. In this 5-year update of part 1 of the COLUMBUS trial, encorafenib plus binimetinib treatment demonstrated continued long-term benefits and a consistent safety profile in patients with

Identifiants

pubmed: 35862871
doi: 10.1200/JCO.21.02659
pmc: PMC9916040
doi:

Substances chimiques

Vemurafenib 207SMY3FQT
binimetinib 181R97MR71
encorafenib 8L7891MRB6
Proto-Oncogene Proteins B-raf EC 2.7.11.1
Lactate Dehydrogenases EC 1.1.-
BRAF protein, human EC 2.7.11.1

Banques de données

ClinicalTrials.gov
['NCT01909453']

Types de publication

Randomized Controlled Trial Clinical Trial, Phase III Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

4178-4188

Commentaires et corrections

Type : CommentIn
Type : ErratumIn
Type : CommentIn

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Auteurs

Reinhard Dummer (R)

University Hospital Zurich, Zurich, Switzerland.

Keith T Flaherty (KT)

Massachusetts General Hospital, Boston, MA.

Caroline Robert (C)

Gustave Roussy and Paris-Saclay University, Villejuif, France.

Ana Arance (A)

Hospital Clinic of Barcelona and IDIBAPS, Barcelona, Spain.

Jan Willem B de Groot (JWB)

Isala Oncology Center, Zwolle, the Netherlands.

Claus Garbe (C)

University Hospital Tubingen, Tubingen, Germany.

Helen J Gogas (HJ)

National and Kapodistrian University of Athens, Athens, Greece.

Ralf Gutzmer (R)

Hannover Medical School, Hannover, and Ruhr-University Bochum, Minden Campus, Germany.

Ivana Krajsová (I)

University Hospital Prague, Prague, Czech Republic.

Gabriella Liszkay (G)

National Institute of Oncology, Budapest, Hungary.

Carmen Loquai (C)

University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.

Mario Mandalà (M)

University of Perugia, Perugia, Italy.

Dirk Schadendorf (D)

University Hospital Essen, West German Cancer Center and German Cancer Consortium, Partner Site Essen, Essen, Germany.

Naoya Yamazaki (N)

National Cancer Center Hospital, Tokyo, Japan.

Alessandra di Pietro (A)

Pfizer, Milan, Italy.

Jean Cantey-Kiser (J)

PharPoint Research, Durham, NC.

Michelle Edwards (M)

Pfizer, New York, NY.

Paolo A Ascierto (PA)

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.

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Classifications MeSH