Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

NCT01966003 ↗

Phase 3 Completed 642 enrolled Amgen Actavis Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.

Timeline

Start: 2013-11-11
Primary completion: 2015-07-23
Completion: 2015-07-23

Outcome

Met primary endpoint

release “today announced a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints.” amgen.com ↗

Publications

Thatcher N, Goldschmidt JH, Thomas M, Schenker M, Pan Z, Paz-Ares Rodriguez L, Breder V, Ostoros G, Hanes V. Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Study. Clin Cancer Res. 2019 Apr 1;25(7):2088-2095. doi: 10.1158/1078-0432.CCR-18-2702. Epub 2019 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABP 215	Unknown	15 mg/kg	Intravenous
Comparator	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous