Primary results from the ASSIST-FL Phase 3 clinical trial of GP2013, a proposed biosimilar of reference rituximab (Roche’s Rituxan, MabThera), showed that GP2013 is a viable rituximab biosimilar candidate for patients with previously untreated advanced follicular lymphoma.
Primary results from the ASSIST-FL Phase 3, multinational, double-blind, randomized, controlled clinical trial of Novartis and Sandoz’s GP2013, a proposed biosimilar of rituximab (Roche’s Rituxan, MabThera), showed that GP2013 is a viable biosimilar candidate for patients with previously untreated advanced follicular lymphoma. Wojciech Jurczak, PhD, of the Department of Hematology, Jagiellonian University, Krakow, Poland, and colleagues published the results of their study in the June 29, 2017, issue of The Lancet Haematology. Reference rituximab is indicated to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis, and microscopic polyangiitis.
The study compared the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GP2013 plus cyclophosphamide, vincristine, and prednisone (GP2013-CVP)—consistent with clinical practice—with reference rituximab-CVP (R-CVP) in adults with previously untreated, advanced-stage follicular lymphoma of World Health Organization (WHO) histological grades 1, 2, or 3a. A total of 858 patients were screened for eligibility; 314 were randomly assigned GP2013, of whom 312 were eventually given GP2013, and 315 were assigned and given reference rituximab. Patients were recruited from 159 centers in 26 countries. Median follow-up was 11.6 months for the primary analysis. Patients received 8 cycles of the biosimilar GP2013-CVP or R-CVP (combination phase), followed by monotherapy maintenance for a 2-year period in those who responded to treatment.
The primary endpoint was comparability in overall response, with equivalence shown if the entire 95% confidence interval (CI) was within an equivalence margin of -12% to 12%. The primary endpoint was analyzed in patients who had received at least 1 (partial or complete) dose of the investigational treatment and who did not have any major protocol deviations. The primary endpoint was met: 271 of 311 patients (87%) receiving GP2013 and 274 of 313 patients (88%) receiving reference rituximab achieved an overall response. The 95% CI was within the pre-defined margin (range: -5.94 to 5.14).
The researchers reported that the occurrence of adverse events (AEs) and serious AEs was similar between the treatment groups: 289 of 312 patients (93%) in the GP2013-CVP group had an AE, and 71 of the 312 patients in the group (23%) had a serious AE. In the R-CVP group, 289 of 315 patients (91%) had an AE, and 63 of those patients (20%) had a serious AE. The most commonly reported AE was neutropenia (neutropenia was also the most common grade 3 or 4 AE during the combination and maintenance phases). The occurrence of anti-drug antibodies was similar between the 2 treatment groups (2% in the GP2013-CVP group, 1% in the R-CVP group).
Secondary endpoints of median progression-free survival and overall survival have not yet been reported, as the study is still blinded and data are evolving, according to Novartis. The final results of the ASSIST-FL study are expected in 2018 after the study has been completed. In addition to ASSIST-FL, Novartis and Sandoz’s GP2013 is being studied in a global development program that includes a comprehensive comparison of the biosimilar candidate and the reference product at the analytical, pre-clinical, and clinical levels. This includes a PK and PD study in RA (ASSIST-RA), an evaluation of the impact of transitioning from the reference product to the proposed biosimilar rituximab (ASSIST-RT). The development program also includes 5 preclinical studies.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval
July 24th 2024Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction
July 20th 2024Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.