5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study

Purpose: The randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation–positive advanced melanoma. We re...

Full description

Bibliographic Details
Authors: Ascierto, Paolo Antonio, Dreno, Brigitte, Larkin, James, Ribas, Antoni, Cruz Merino, Luis de la, McArthur, Grant A.
Format: article
Status:Published version
Publication Date:2021
Country:España
Institution:Universidad de Sevilla (US)
Repository:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/138294
Online Access:https://hdl.handle.net/11441/138294
https://doi.org/10.1158/1078-0432.CCR-21-0809
Access Level:Open access
Keyword:Cobimetinib
Vemurafenib
BRAFV600
Melanoma
CoBRIM study
id ES_7ad04f78f72ffdef0b3ff0f4214db5be
oai_identifier_str oai:idus.us.es:11441/138294
network_acronym_str ES
network_name_str España
repository_id_str
spelling 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM studyAscierto, Paolo AntonioDreno, BrigitteLarkin, JamesRibas, AntoniCruz Merino, Luis de laMcArthur, Grant A.CobimetinibVemurafenibBRAFV600MelanomaCoBRIM studyPurpose: The randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation–positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized. Patients and Methods: Eligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1–21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily). Results: 495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3–28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0–19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5–14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6–7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports. Conclusions: Extended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation–positive advanced melanoma.American Association for Cancer ResearchMedicina2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/138294https://doi.org/10.1158/1078-0432.CCR-21-0809reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésClinical Cancer Research, 27 (19), 5225-5235.http://doi.org/10.1158/1078-0432.CCR-21-0809info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1382942026-06-17T12:51:07Z
dc.title.none.fl_str_mv 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
title 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
spellingShingle 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
Ascierto, Paolo Antonio
Cobimetinib
Vemurafenib
BRAFV600
Melanoma
CoBRIM study
title_short 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
title_full 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
title_fullStr 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
title_full_unstemmed 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
title_sort 5-year outcomes with cobimetinib plus vemurafenib in BRAFV600 mutation⇓positive advanced melanoma: extended follow-up of the coBRIM study
dc.creator.none.fl_str_mv Ascierto, Paolo Antonio
Dreno, Brigitte
Larkin, James
Ribas, Antoni
Cruz Merino, Luis de la
McArthur, Grant A.
author Ascierto, Paolo Antonio
author_facet Ascierto, Paolo Antonio
Dreno, Brigitte
Larkin, James
Ribas, Antoni
Cruz Merino, Luis de la
McArthur, Grant A.
author_role author
author2 Dreno, Brigitte
Larkin, James
Ribas, Antoni
Cruz Merino, Luis de la
McArthur, Grant A.
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
dc.subject.none.fl_str_mv Cobimetinib
Vemurafenib
BRAFV600
Melanoma
CoBRIM study
topic Cobimetinib
Vemurafenib
BRAFV600
Melanoma
CoBRIM study
description Purpose: The randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation–positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized. Patients and Methods: Eligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1–21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily). Results: 495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3–28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0–19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5–14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6–7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports. Conclusions: Extended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation–positive advanced melanoma.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/138294
https://doi.org/10.1158/1078-0432.CCR-21-0809
url https://hdl.handle.net/11441/138294
https://doi.org/10.1158/1078-0432.CCR-21-0809
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Clinical Cancer Research, 27 (19), 5225-5235.
http://doi.org/10.1158/1078-0432.CCR-21-0809
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv American Association for Cancer Research
publisher.none.fl_str_mv American Association for Cancer Research
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869411467131879424
score 15,301603

Similar Items