Biosimilar and Reference Rituximab May Have Similar ORR in Follicular Lymphoma
Patients with untreated FL were randomly assigned to receive cyclophosphamide, vincristine, and prednisone (CVP) plus rituximab (R) or GP2013 for 8 cycles followed by 2 years of monotherapy maintenanc
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Rituximab and its biosimilar GP2013 may have equivalent overall response rates (ORR) in patients with advanced, treatment-naive follicular lymphoma (FL), according to evidence from the ASSIST-FL study presented at the European Society of Medical Oncology (ESMO) 2017 Congress in Spain.1
For this confirmatory phase 3 study (ClinicalTrials.gov Identifier: NCT01419665), study authors assessed the safety, efficacy, pharmacodynamics, and pharmacokinetic profiles of rituximab and GP2013.
Patients with untreated FL were randomly assigned to receive cyclophosphamide, vincristine, and prednisone (CVP) plus rituximab (R) or GP2013 for 8 cycles followed by 2 years of monotherapy maintenance in patients who responded to treatment. Patients were stratified according to region and Follicular Lymphoma International Prognostic Index (FLIPI) risk score.
Patients in the GP2013 group achieved an ORR of 87.1% compared with 87.5% in patients receiving reference rituximab (difference, -0.40% [95% CI, -5.94%-5.14%]), and subgroup analyses suggested that the ORR was similar in the treatment groups despite the heterogeneity of gender, race, age, bulky disease, or geographic region.
Subgroup analyses showed that there were numerical treatment differences for patients with FLIPI scores of 0 to 2 and 3 to 5 of -8.41 (95% CI, -17.09-0.28) and 5.74 (95% CI, -1.70-13.17), respectively.
An interim analysis performed after an additional year of follow-up resulted in safety data that demonstrated the patterns and rates of adverse events (AEs) (combination period: GP2013-CVP, 92.9%; R-CVP, 91.4%; maintenance period: GP2013, 72.0%; R, 69.4%) and serious AEs (combination period: GP2013-CVP, 22.8%; R-CVP, 20.0%; maintenance period: GP2013 7.9%; R, 7.1%) were similar between treatment groups.
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The investigators concluded by adding, “Based on the totality of evidence, GP2013 was approved by the [European Medicines Agency] and represents an important option for patients that need rituximab and to help sustain the cost of cancer care.”
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- Jurczak W, Moreira I, Govindbabu KS, et al. 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. Presented at: ESMO 2017 Congress; Madrid, Spain: September 8-12, 2017. Abstract 994O.