A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

Summary

This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

Timeline

Start

2014-09-30

Primary completion

2017-10-23

Completion

2018-04-19

Outcome

Met primary endpoint

paper 95% CI (- 4.16 to 13.47), which was entirely within the prespecified equivalence margin. PMID 31820339 ↗

release “the REFLECTIONS B328-06 study, a comparative safety and efficacy study of PF-05280586 versus Rituxan ® /MabThera ® (rituximab-EU) i , met its primary endpoint” pfizer.com ↗

Publications

• Courville J, Nastoupil L, Kaila N, Kelton J, Zhang J, Alcasid A, Nava-Parada P. Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. BioDrugs. 2021 Jul;35(4):459-468. doi: 10.1007/s40259-021-00487-6. Epub 2021 Jun 21.
• Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(R)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-05280586	Unknown	375 mg/m2	Intravenous
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Indications