Biosimilar and Reference Rituximab May Have Similar ORR in Follicular Lymphoma

Share this content:
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
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
The following article features coverage from the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain. Click here to read more of Cancer Therapy Advisor's conference coverage.

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.

RELATED: Histological Transformation: A Key Predictor of Outcomes in Follicular Lymphoma

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.”

Read more of Cancer Therapy Advisor's coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.

Reference

  1. 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.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs