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dc.contributor.authorAscierto, PA
dc.contributor.authorDréno, B
dc.contributor.authorLarkin, J
dc.contributor.authorRibas, A
dc.contributor.authorLiszkay, G
dc.contributor.authorMaio, M
dc.contributor.authorMandalà, M
dc.contributor.authorDemidov, L
dc.contributor.authorStroyakovskiy, D
dc.contributor.authorThomas, L
dc.contributor.authorde la Cruz-Merino, L
dc.contributor.authorAtkinson, V
dc.contributor.authorDutriaux, C
dc.contributor.authorGarbe, C
dc.contributor.authorHsu, J
dc.contributor.authorJones, S
dc.contributor.authorLi, H
dc.contributor.authorMcKenna, E
dc.contributor.authorVoulgari, A
dc.contributor.authorMcArthur, GA
dc.coverage.spatialUnited States
dc.date.accessioned2022-08-19T13:16:14Z
dc.date.available2022-08-19T13:16:14Z
dc.date.issued2021-10-01
dc.identifier1078-0432.CCR-21-0809
dc.identifier.citationClinical Cancer Research, 2021, 27 (19), pp. 5225 - 5235en_US
dc.identifier.issn1078-0432
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5284
dc.identifier.eissn1557-3265
dc.identifier.eissn1557-3265
dc.identifier.doi10.1158/1078-0432.CCR-21-0809
dc.identifier.doi10.1158/1078-0432.CCR-21-0809
dc.description.abstractPURPOSE: 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.
dc.formatPrint
dc.format.extent5225 - 5235
dc.languageeng
dc.language.isoengen_US
dc.publisherAMER ASSOC CANCER RESEARCHen_US
dc.relation.ispartofClinical Cancer Research
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/en_US
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectAzetidines
dc.subjectFollow-Up Studies
dc.subjectHumans
dc.subjectMelanoma
dc.subjectMutation
dc.subjectPiperidines
dc.subjectProto-Oncogene Proteins B-raf
dc.subjectSkin Neoplasms
dc.subjectVemurafenib
dc.title5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study.en_US
dc.typeJournal Article
dcterms.dateAccepted2021-06-11
dc.date.updated2022-08-19T13:15:30Z
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1158/1078-0432.CCR-21-0809en_US
rioxxterms.licenseref.startdate2021-10-01
rioxxterms.typeJournal Article/Reviewen_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/34158360
pubs.issue19
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.publication-statusPublished
pubs.volume27
dc.contributor.icrauthorLarkin, James
icr.provenanceDeposited by Mr Arek Surman on 2022-08-19. Deposit type is initial. No. of files: 1. Files: 5225.pdf


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