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Haematological malignancies

4876 - Equivalent Efficacy of a Biosimilar Rituximab and Reference Rituximab in Previously Untreated Advanced Follicular Lymphoma: Extended Results of ASSIST-FL, a Confirmatory Phase III Study

Date

10 Sep 2017

Session

Haematological malignancies

Topics

Lymphomas

Presenters

Wojciech Jurczak

Citation

Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373

Authors

W. Jurczak1, I. Moreira2, K. Setty Govindbabu3, E. Munhoz4, M. Echeveste5, P. Giri6, N. Castro7, J. Pereira8, A. Luiza9, S. Alexeev10, D. Osmanov11, P. Zhu12, S. Alexandrova13, A. Zubel14, O. Harlin14, J. Amersdorffer14

Author affiliations

  • 1 Dept Of Hematology, Jagiellonian University Krakow, 31-501 - Kraków/PL
  • 2 Dept Of Oncohaematology, Portuguese Institute of Oncology of Porto Francisco Gentil, Porto/PT
  • 3 Dept Of Medical Oncology, Curie Center of Oncology and Kidwai Memorial Institute of Oncology, Bangalore/IN
  • 4 Dept Of Clinical Oncology, Hospital Erasto Gaertner, Curitiba/BR
  • 5 Dept Of Hematology, Hospital de Donostia, San Sebastian/ES
  • 6 Dept Of Hematology, Royal Adelaide Hospital, Adelaide/AU
  • 7 Dept Of Hematology, Hospital de Cancer de Barretos, Sao Paulo/BR
  • 8 Dept Of Hematology, Hospital das Clinicas da Faculdade de Medcina da USP, Sao Paulo/BR
  • 9 Institute Of Hematology, Medical Center of Galil, Naharyia/IL
  • 10 Dept Of Hematology, Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov, St. Petersburg/RU
  • 11 Dept Of Chemotherapy For Hematological Malignancies, Blokhin Cancer Research Center under the Russian Academy of Medical Sciences, Moscow/RU
  • 12 Clinical Pharmacology, Sandoz Inc., Princeton/US
  • 13 Biostatistics, Sandoz Inc., Princeton/US
  • 14 Medical Affairs, Hexal AG, Holzkirchen/DE
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Abstract 4876

Background

GP2013, a rituximab biosimilar, has been developed according to biosimilar development guidelines, with clinical trials in rheumatoid arthritis and follicular lymphoma (FL).

Methods

This confirmatory phase III, double-blind, randomized, controlled trial compared efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of GP2013-CVP versus rituximab-CVP (R-CVP) in previously untreated, advanced-stage FL. The primary endpoint was equivalence in overall response rate (ORR), defined by 95% confidence interval [CI] with a margin of ± 12%. Secondary, non-powered endpoints comprised progression-free and overall survival, PK, PD, and safety. Patients were stratified by region and FLIPI risk score and randomized (1:1) to 8 cycles of GP2013-CVP (n = 314) or R-CVP (n = 315), followed by monotherapy maintenance for up to 2 years in responders (ClinicalTrials.gov identifier: NCT01419665).

Results

The primary endpoint, equivalence of ORR between treatments, was met (GP2013-CVP: 87.1%; R-CVP: 87.5%; difference [95%CI] –0.40% [–5.94%, 5.14%]). Subgroup analyses suggested that ORR was similar between GP2013-CVP and R-CVP regardless of age (

Conclusions

The study demonstrated equivalence in ORR between the biosimilar GP2013 and reference rituximab in patients with previously untreated, advanced FL. Similarity in ORR was observed across subgroups and safety profiles were also comparable. Based on the totality of evidence, GP2013 was approved by the EMA and represents an important option for patients that need rituximab and to help sustain the cost of cancer care.

Clinical trial identification

NCT01419665

Legal entity responsible for the study

Hexal AG, a Sandoz company, part of the Novartis group

Funding

Hexal AG

Disclosure

W. Jurczak: Received research funding and lecture honoraria from Sandoz. P. Zhu, S. Alexandrova: Employee of Sandoz Inc. Princeton, NJ, USA. A. Zubel, O. Harlin, J. Amersdorffer: Employee of Hexal AG, Holzkirchen, Germany. All other authors have declared no conflicts of interest.

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