Journal article
Vemurafenib in metastatic melanoma patients with brain metastases: An open-label, single-arm, phase 2, multicentre study
GA McArthur, M Maio, A Arance, P Nathan, C Blank, MF Avril, C Garbe, A Hauschild, D Schadendorf, O Hamid, M Fluck, M Thebeau, J Schachter, R Kefford, M Chamberlain, M Makrutzki, S Robson, R Gonzalez, K Margolin
Annals of Oncology | OXFORD UNIV PRESS | Published : 2017
Abstract
Background: Vemurafenib has shown activity in patients with BRAFV600 mutated melanoma with brain metastases (BM). This phase 2 study evaluated vemurafenib in patients with/without prior treatment for BM. Methods: Patients with BRAFV600 mutated melanoma with BM were enrolled into cohort 1 (previously untreated BM) and cohort 2 (previously treated BM) and received vemurafenib (960mg BID) until disease progression (PD) or intolerance. Primary endpoint was best overall response rate (BORR) in the brain in cohort 1 that was evaluated using modified RECIST 1.1 criteria using lesions≥ 0.5 cm to assess response. Results: 146 patients were treated (cohort 1 n=90; cohort 2 n=56), 62% of whom were male..
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Funding Acknowledgements
The study was funded and sponsored by F. Hoffmann-La Roche Ltd. No grant number is applicable.