Encorafenib Plus Binimetinib in Patients with <i>BRAF</i> <sup>V600</sup> -Mutant Non-Small Cell Lung Cancer: Phase II PHAROS Study Design
Gregory J. Riely, Myung‐Ju Ahn, Enriqueta Felip, Suresh S. Ramalingam, Egbert F. Smit, Anne S. Tsao, Ann Alcasid, Tiziana Usari, Paul Wissel, Keith D. Wilner, Bruce E. Johnson
Abstract
BRAFV600 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 BRAFV600-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 BRAFV600-mutant NSCLC.