In a nutshell
This study compared rituximab (Rituxan) and CT-P10 treatments for patients with previously untreated advanced stage follicular lymphoma. The study concluded that CT-P10 is just as safe and effective as name-brand rituximab.
Follicular lymphoma (FL) is a type of non-Hodgkin lymphoma. It is commonly treated with the R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone). Rituximab has greatly improved patient outcomes.
The patent on rituximab expired in 2016. Generic, biosimilar (almost exactly the same as the name-brand product) medication is being manufactured for rituximab. CT-P10 is one biosimilar medication. Research must confirm that CT-P10 produces the same outcomes as name-brand rituximab.
Methods & findings
140 patients were recruited for this study. All patients had advanced stage (III or IV) FL. 70 patients were randomized to receive CT-P10 plus CVP. 70 patients were randomized to receive rituximab plus CVP. All patients received 375 mg/m2 of either CT-P10 or rituximab on day 1 of a 21-day cycle. Patients received 8 cycles of this regimen.
30% of patients in the CT-P10 group experienced a complete response (no detectable cancer). 22% of patients in the rituximab group experienced a complete response. The overall response rate (patients with complete or partial response) for patients in the CT-P10 group was 97%. The overall response rate for patients in the rituximab group was 92.6%.
Patients in each group had similar numbers of adverse events (any side effect that occurs during treatment). There was no significant difference between adverse events between the CT-P10 group (53%) and the rituximab group (49%).
The bottom line
The authors concluded that CT-P10 produces similar outcomes and has a similar safety profile to name-brand rituximab, and is a good treatment option for patients with advanced stage follicular lymphoma.
Published By :
The Lancet. Haematology
Aug 01, 2017
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