Dr. Welslau on REFLECT Interim Safety Analysis in DLBCL

Manfred Welslau, MD
Published: Friday, Sep 20, 2019



Manfred Welslau, MD, Internal Medicine, Hematology and Oncology, Onkologie Aschaffenburg, discusses the first interim safety analysis in treatment-naïve, CD20-positive diffuse large B-cell lymphoma (DLBCL) following the approval of Rixathon, a Sandoz biosimilar for rituximab (Rituxan).
 
The multicenter, open-label REFLECT trial recruited 80 patients 18 years or older who were eligible to receive product-label rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP).
 
The primary endpoint of REFLECT is complete remission. Secondary endpoints are progression-free survival at 12 months, as well as overall survival and adverse events (AEs).
 
Interim baseline data and safety results were as expected. Polyneuropathy (n = 10, 12.5%), anemia (n = 8, 10%) and fatigue (n = 8, 10%) were the most commonly reported AEs. Overall, AEs were reported in 66% of patients with 24% reporting serious AEs.
 
The study is ongoing, but Weslau is optimistic about the totality of evidence for biosimilarity and for future biosimilar application in this space.
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Manfred Welslau, MD, Internal Medicine, Hematology and Oncology, Onkologie Aschaffenburg, discusses the first interim safety analysis in treatment-naïve, CD20-positive diffuse large B-cell lymphoma (DLBCL) following the approval of Rixathon, a Sandoz biosimilar for rituximab (Rituxan).
 
The multicenter, open-label REFLECT trial recruited 80 patients 18 years or older who were eligible to receive product-label rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP).
 
The primary endpoint of REFLECT is complete remission. Secondary endpoints are progression-free survival at 12 months, as well as overall survival and adverse events (AEs).
 
Interim baseline data and safety results were as expected. Polyneuropathy (n = 10, 12.5%), anemia (n = 8, 10%) and fatigue (n = 8, 10%) were the most commonly reported AEs. Overall, AEs were reported in 66% of patients with 24% reporting serious AEs.
 
The study is ongoing, but Weslau is optimistic about the totality of evidence for biosimilarity and for future biosimilar application in this space.

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