Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study

PURPOSE BEACON CRC evaluated encorafenib plus cetuximab with or without binimetinib versus investigators' choice of irinotecan or FOLFIRI plus cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), after progression on 1-2 prior regimens. In the previously reported pr...

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Autores: Tabernero, Josep, Grothey, Axel, Van Cutsem, Eric, Wasan, Harpreet, Yoshino, Takayuki, Desai, Jayesh, Ciardiello, Fortunato, Loupakis, Fotio, Hong, Yong Sang
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:UVic-UCC
Repositorio:RiUVic. Repositori institucional de la UVic-UCC
OAI Identifier:oai:dspace.uvic.cat:10854/7720
Acceso en línea:http://hdl.handle.net/10854/7720
https://doi.org/10.1200/JCO.20.02088
Access Level:acceso abierto
Palabra clave:Còlon -- Càncer
Metàstasi
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spelling Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON studyTabernero, JosepGrothey, AxelVan Cutsem, EricWasan, HarpreetYoshino, TakayukiDesai, JayeshCiardiello, FortunatoLoupakis, FotioHong, Yong SangCòlon -- CàncerMetàstasiPURPOSE BEACON CRC evaluated encorafenib plus cetuximab with or without binimetinib versus investigators' choice of irinotecan or FOLFIRI plus cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), after progression on 1-2 prior regimens. In the previously reported primary analysis, encorafenib, binimetinib plus cetuximab (ENCO/BINI/CETUX; triplet) and encorafenib plus cetuximab (ENCO/CETUX; doublet) regimens improved overall survival (OS) and objective response rate (ORR; by blinded central review) versus standard of care. The purpose of this analysis was to report updated efficacy and safety data. METHODS In this open-label, phase III trial, 665 patients with BRAF V600E-mutant mCRC were randomly assigned 1:1:1 to receive triplet, doublet, or control. Primary end points were OS and independently reviewed ORR comparing triplet to control. OS for doublet versus control was a key secondary end point. Updated analyses include 6 months of additional follow-up and ORR for all randomized patients. RESULTS Patients received triplet (n=224), doublet (n=220), or control (n=221). Median OS was 9.3 months (95% CI, 8.2 to 10.8) for triplet and 5.9 months (95% CI, 5.1 to 7.1) for control (hazard ratio [HR], 0.60 [95% CI, 0.47 to 0.75]). Median OS for doublet was 9.3 months (95% CI, 8.0 to 11.3) (HR v control, 0.61 [95% CI, 0.48 to 0.77]). Confirmed ORR was 26.8% (95% CI, 21.1% to 33.1%) for triplet, 19.5% (95% CI, 14.5% to 25.4%) for doublet, and 1.8% (95% CI, 0.5% to 4.6%) for control. Adverse events were consistent with the prior primary analysis, with grade >= 3 adverse events in 65.8%, 57.4%, and 64.2% for triplet, doublet, and control, respectively. CONCLUSION In the BEACON CRC study, encorafenib plus cetuximab improved OS, ORR, and progression-free survival in previously treated patients in the metastatic setting compared with standard chemotherapy. Based on the primary and updated analyses, encorafenib plus cetuximab is a new standard care regimen for previously treated patients with BRAF V600E mCRC. (C) 2021 by American Society of Clinical OncologySupported by the Cancer Center Core Grant P30 CA 008748 to Memorial Sloan-Kettering Cancer Center. The BEACON trial was sponsored by Pfizer and was conducted with support from Merck KGaA Darmstadt, Germany (for sites outside of North America), ONO Pharmaceutical, and Pierre Fabre.American Society of Clinical OncologyUniversitat de Vic - Universitat Central de Catalunya. Facultat de Medicina2024202420212021info:eu-repo/semantics/articleinfo:eu-repo/publishedVersionapplication/pdf13 p.application/pdfhttp://hdl.handle.net/10854/7720https://doi.org/10.1200/JCO.20.02088reponame:RiUVic. Repositori institucional de la UVic-UCCinstname:UVic-UCCInglésAquest document està subjecte a aquesta llicència Creative Commonshttps://creativecommons.org/licenses/by-nc-nd/4.0/deed.cainfo:eu-repo/semantics/openAccessoai:dspace.uvic.cat:10854/77202026-06-07T19:15:21Z
dc.title.none.fl_str_mv Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
title Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
spellingShingle Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
Tabernero, Josep
Còlon -- Càncer
Metàstasi
title_short Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
title_full Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
title_fullStr Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
title_full_unstemmed Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
title_sort Encorafenib plus cetuximab as a new standard of care for previously treated BRAF V600E-mutant metastatic colorectal cancer: Updated survival results and subgroup analyses from the BEACON study
dc.creator.none.fl_str_mv Tabernero, Josep
Grothey, Axel
Van Cutsem, Eric
Wasan, Harpreet
Yoshino, Takayuki
Desai, Jayesh
Ciardiello, Fortunato
Loupakis, Fotio
Hong, Yong Sang
author Tabernero, Josep
author_facet Tabernero, Josep
Grothey, Axel
Van Cutsem, Eric
Wasan, Harpreet
Yoshino, Takayuki
Desai, Jayesh
Ciardiello, Fortunato
Loupakis, Fotio
Hong, Yong Sang
author_role author
author2 Grothey, Axel
Van Cutsem, Eric
Wasan, Harpreet
Yoshino, Takayuki
Desai, Jayesh
Ciardiello, Fortunato
Loupakis, Fotio
Hong, Yong Sang
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat de Vic - Universitat Central de Catalunya. Facultat de Medicina
dc.subject.none.fl_str_mv Còlon -- Càncer
Metàstasi
topic Còlon -- Càncer
Metàstasi
description PURPOSE BEACON CRC evaluated encorafenib plus cetuximab with or without binimetinib versus investigators' choice of irinotecan or FOLFIRI plus cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), after progression on 1-2 prior regimens. In the previously reported primary analysis, encorafenib, binimetinib plus cetuximab (ENCO/BINI/CETUX; triplet) and encorafenib plus cetuximab (ENCO/CETUX; doublet) regimens improved overall survival (OS) and objective response rate (ORR; by blinded central review) versus standard of care. The purpose of this analysis was to report updated efficacy and safety data. METHODS In this open-label, phase III trial, 665 patients with BRAF V600E-mutant mCRC were randomly assigned 1:1:1 to receive triplet, doublet, or control. Primary end points were OS and independently reviewed ORR comparing triplet to control. OS for doublet versus control was a key secondary end point. Updated analyses include 6 months of additional follow-up and ORR for all randomized patients. RESULTS Patients received triplet (n=224), doublet (n=220), or control (n=221). Median OS was 9.3 months (95% CI, 8.2 to 10.8) for triplet and 5.9 months (95% CI, 5.1 to 7.1) for control (hazard ratio [HR], 0.60 [95% CI, 0.47 to 0.75]). Median OS for doublet was 9.3 months (95% CI, 8.0 to 11.3) (HR v control, 0.61 [95% CI, 0.48 to 0.77]). Confirmed ORR was 26.8% (95% CI, 21.1% to 33.1%) for triplet, 19.5% (95% CI, 14.5% to 25.4%) for doublet, and 1.8% (95% CI, 0.5% to 4.6%) for control. Adverse events were consistent with the prior primary analysis, with grade >= 3 adverse events in 65.8%, 57.4%, and 64.2% for triplet, doublet, and control, respectively. CONCLUSION In the BEACON CRC study, encorafenib plus cetuximab improved OS, ORR, and progression-free survival in previously treated patients in the metastatic setting compared with standard chemotherapy. Based on the primary and updated analyses, encorafenib plus cetuximab is a new standard care regimen for previously treated patients with BRAF V600E mCRC. (C) 2021 by American Society of Clinical Oncology
publishDate 2021
dc.date.none.fl_str_mv 2021
2021
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/publishedVersion
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10854/7720
https://doi.org/10.1200/JCO.20.02088
url http://hdl.handle.net/10854/7720
https://doi.org/10.1200/JCO.20.02088
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv Aquest document està subjecte a aquesta llicència Creative Commons
https://creativecommons.org/licenses/by-nc-nd/4.0/deed.ca
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Aquest document està subjecte a aquesta llicència Creative Commons
https://creativecommons.org/licenses/by-nc-nd/4.0/deed.ca
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
13 p.
application/pdf
dc.publisher.none.fl_str_mv American Society of Clinical Oncology
publisher.none.fl_str_mv American Society of Clinical Oncology
dc.source.none.fl_str_mv reponame:RiUVic. Repositori institucional de la UVic-UCC
instname:UVic-UCC
instname_str UVic-UCC
reponame_str RiUVic. Repositori institucional de la UVic-UCC
collection RiUVic. Repositori institucional de la UVic-UCC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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