GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

NCT01419665 ↗

Phase 3 Completed 629 enrolled Sandoz Novartis Pharmaceuticals · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.

Timeline

Start: 2011-12-01
Primary completion: 2015-07-10
Completion: 2018-01-22

Outcome

Met primary endpoint

paper The primary endpoint, equivalence of overall response, was met PMID 28712941 ↗

release “The ASSIST-FL trial met its primary endpoint, with Sandoz biosimilar rituximab demonstrating equivalent efficacy in addition to safety, pharmacokinetics and pharmacodynamics” novartis.com ↗

Publications

Jurczak W, Moreira I, Kanakasetty GB, Munhoz E, Echeveste MA, Giri P, Castro N, Pereira J, Akria L, Alexeev S, Osmanov E, Zhu P, Alexandrova S, Zubel A, Harlin O, Amersdorffer J. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017 Aug;4(8):e350-e361. doi: 10.1016/S2352-3026(17)30106-0. Epub 2017 Jul 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GP2013	Unknown	—	—
Comparator	Rituximab	Monoclonal antibody	—	—