Phase 1b Open-Label Trial of Afatinib Plus Xentuzumab (BI 836845) in Patients With EGFR Mutation-Positive NSCLC After Progression on EGFR Tyrosine Kinase Inhibitors
Journal
JTO Clinical and Research Reports
Journal Volume
2
Journal Issue
9
Pages
100206
Date Issued
2021
Author(s)
Park K.
Tan D.S.W.
Su W.-C.
Cho B.C.
Kim S.-W.
Lee K.H.
Wang C.-C.
Seto T.
Huang D.C.-L.
Jung H.H.
Hsu M.-C.
Bogenrieder T.
Abstract
INTRODUCTION: mutation-positive NSCLC. METHODS: T790M mutation was required in part B. Part A used a 3 + 3 design, with a starting dose of xentuzumab 1000 mg/wk (intravenous) and afatinib 30 mg/d (oral). Primary endpoints were the maximum tolerated dose of the combination (part A) and objective response (part B). RESULTS: A total of 16 patients each were treated in parts A and B. Maximum tolerated dose was xentuzumab 1000 mg/wk plus afatinib 40 mg/d. No patients in part B had an objective response, but 10 had stable disease (median [range] duration of disease control: 2.3 [0.8-10.9] mo). The most common drug-related adverse events were diarrhea (75 %), paronychia (69 %), and rash (69 %) in part A and diarrhea (31 %), rash (19 %), paronychia (19 %), and fatigue (19 %) in part B. CONCLUSIONS: mutation-positive, T790M-negative NSCLC after progression on afatinib.
SDGs
Publisher
Elsevier Inc.
Type
journal article