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Posted by on Oct 2, 2017 in Non-Hodgkin lymphoma | 0 comments

In a nutshell

This study compared rituximab and GP2013 treatments in patients with previously untreated advanced stage follicular lymphoma. The study concluded that patients treated with GP2013 had similar outcomes to patients treated with rituximab

Some background

Follicular lymphoma (FL) is a type of non-Hodgkin lymphoma. It is commonly treated with a chemotherapy regimen called R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone). When rituximab was first introduced, it significantly improved outcomes for FL patients.

The patent for rituximab expired in September 2016. Medication that is biosimilar (almost exactly the same as the brand-name product) to rituximab is starting to be manufactured. GP2013 is one of these biosimilar medications. Research is needed to confirm that GP2013 produces the same good outcomes as name-brand rituximab

Methods & findings

629 patients participated in this study. 314 were randomized to receive GP2013 plus CVP. 315 were randomized to receive rituximab plus CVP. This study included an initial treatment phase of 6 months and a maintenance phase of 2 years. Patients received either GP2013 or rituximab plus CVP in the treatment phase. In the maintenance phase, patients only received either GP2013 or rituximab (no CVP). 

At the end of the treatment phase, the overall response rate (at least some reduction in tumor size) was 87% in the GP2013 group and 88% in the rituximab group. The difference was not significant. 15% of patients in the GP2013 group experienced a complete response (no detectable cancer). 13% of patients in the rituximab group experienced a complete response.

The most common severe side effect during the treatment phase was low white blood cell levels. This occured in 18% of the GP2013 group and 21% of the rituximab group.

After the maintenance phase, the average overall survival time (time from treatment to death from any cause) was not reached for either group. 

The bottom line

The authors concluded that patients with advanced stage follicular lymphoma have similar outcomes when treated with either GP2013 or rituximab. 

Published By :

The Lancet. Haematology

Date :

Aug 01, 2017

Original Title :

Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study.

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