Open AccessEncorafenib plus binimetinib in patients withBRAFV600-mutant non-small cell lung cancer: phase II PHAROS study design
Author(s) -
Gregory J. Riely,
MyungJu Ahn,
Enriqueta Felip,
Suresh S. Ramalingam,
Egbert F. Smit,
Anne S. Tsao,
Ann Alcasid,
Tiziana Usari,
Paul Wissel,
Keith D. Wilner,
Bruce E. Johnson
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2021-1250
Subject(s) - medicine , mek inhibitor , oncology , lung cancer , cancer , clinical trial , mutant , mapk/erk pathway , progressive disease , adverse effect , clinical endpoint , cancer research , phases of clinical research , disease , gene , kinase , genetics , biology
BRAF V600 oncogenic driver mutations occur in 1–2% of non-small-cell lung cancers (NSCLCs) and have been shown to be a clinically relevant target. Preclinical/clinical evidence support the efficacy and safety of BRAF and MEK inhibitor combinations in patients with NSCLC with these mutations. We describe the design of PHAROS, an ongoing, open-label, single-arm, phase II trial evaluating the BRAF inhibitor encorafenib plus the MEK inhibitor binimetinib in patients with metastatic BRAF V600 -mutant NSCLC, as first- or second-line treatment. The primary end point is objective response rate, based on independent radiologic review (per RECIST v1.1); secondary objectives evaluated additional efficacy end points and safety. Results from PHAROS will describe the antitumor activity/safety of encorafenib plus binimetinib in patients with metastatic BRAF V600 -mutant NSCLC.