作者
Pier Francesco Ferrucci, Anna Maria Di Giacomo, Michele Del Vecchio, Victoria Atkinson, Henrik Schmidt, Jacob Schachter, Paola Queirolo, Georgina V Long, Rosalie Stephens, Inge Marie Svane, Michal Lotem, Mahmoud Abu-Amna, Eduard Gasal, Razi Ghori, Scott J Diede, Elizabeth S Croydon, Antoni Ribas, Paolo Antonio Ascierto
发表日期
2020
期刊
Journal for immunotherapy of cancer
卷号
8
期号
2
出版商
BMJ Publishing Group
简介
Background
In the KEYNOTE-022 study, pembrolizumab with dabrafenib and trametinib (triplet) improved progression-free survival (PFS) versus placebo with dabrafenib and trametinib (doublet) without reaching statistical significance. Mature results on PFS, duration of response (DOR), and overall survival (OS) are reported.
Methods
The double-blind, phase 2 part of KEYNOTE-022 enrolled patients with previously untreated BRAF V600E/K-mutated advanced melanoma from 22 sites in seven countries. Patients were randomly assigned 1: 1 to intravenous pembrolizumab (200 mg every 3 weeks) or placebo plus dabrafenib (150 mg orally two times per day) and trametinib (2 mg orally one time a day). Primary endpoint was PFS. Secondary endpoints were objective response rate, DOR, and OS. Efficacy was assessed in the intention-to-treat population, and safety was assessed in all patients who received at least …
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PF Ferrucci, AM Di Giacomo, M Del Vecchio… - Journal for immunotherapy of cancer, 2020