Tony Hagen is senior managing editor for The Center for Biosimilars®.
Investigators reported an 88% overall response rate for a Sandoz rituximab biosimilar in combination with chemotherapy in patients with CD20-positive diffuse large B-cell lymphoma.
The overall response rate (ORR) was 88% in an interim analysis study of a Sandoz rituximab biosimilar evaluated in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with CD20-positive diffuse large B-cell lymphoma (DLBCL), according to data presented at EHA20 Virtual, the 25th European Hematology Association (EHA) Congress.
The international REFLECT trial was the first prospective postapproval study to evaluate a rituximab biosimilar in this context. The study employed Sandoz’s rituximab biosimilar Rixathon (SDZ-RTX), which is approved in Europe, Japan, Australia, and Switzerland, among more than 20 countries and regions, for all indications of reference rituximab.
The efficacy and safety data presented this month at EHA20 Virtual confirmed findings from REFLECT released in 2019 at meetings of the American Society of Clinical Oncology and EHA, investigators said.
The primary end point was complete response (CR) and secondary end points were overall response and progression-free survival at 24 months, safety, and quality of life. Of the patients enrolled (N = 170), 38% completed the first 12 months of observation, 41% were ongoing, and 21% discontinued by the data cutoff (8% discontinued because of progressive disease).
Findings from REFLECT
At the end of treatment, CR was 57% and partial response was 31%. Investigators said 61% and 29% reported enlarged lymph nodes and disease-related pain, respectively.
They said 32% of patients had nodal lesions >15 mm. Most had an Eastern Cooperative Oncology Group functional performance score of 0 (35%) or 1 (46%), and for 70%, the Karnofsky performance scale score for functional impairment was ≥70%.
Early-stage (I-IIB) disease, low-to-intermediate disease risk (International Prognostic Index 0-2), and known DLBCL symptoms were reported for 55%, 50%, and 30% of patients, respectively.
Treatment-related adverse events (AEs) were reported for 28% of patients, and the rates of serious AEs and treatment-related serious AEs were 37% and 7%, respectively. Investigators said 2.5% of patients died on treatment.
The most common AEs were organ related (83%), general disorders and administration site conditions (40%), blood and lymphatic system disorders (38%), gastrointestinal (33%), and nervous system (32%). Among these, 21% experienced fatigue; 24%, anemia; 12%, nausea; and 15%, polyneuropathy.
Investigators concluded their findings reconfirm the safety and efficacy profile for this treatment combination in patients with DLBCL treated in a real-world setting. No new safety concerns were observed.
Welslau M, Marschner N, Otremba B, Topaly J, Bittencourt da Silva L. REFLECT real-world evidence: non-interventional, prospective study update on the efficacy and safety of Sandoz biosimilar rituximab for the treatment of diffuse large b-cell lymphoma (DLBCL). Presented at: EHA25 Virtual; June 11-21, 2020. Poster EP1245. library.ehaweb.org/eha/2020/eha25th/293734