Dr. Welslau on REFLECT Interim Safety Analysis in DLBCL

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.