CT-P10 and Rituximab Yield Favorable Outcomes in Patients With FL
Findings from a randomized phase 3 study showed the efficacy and safety of CT-P10 and the anti-CD20 monoclonal antibody rituximab in patients with untreated advanced follicular lymphoma (FL; Blood Adv. 2021 Sept 14;5(17):3354-3361.)
According to lead investigator Christian Buske, MD, Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, University Hospital of Ulm, Ulm, Germany, and co-investigators, rituximab biosimilars are an important aspect of treating FL.
“Rituximab biosimilars (such as CT-P10) are a cornerstone of treatment of advanced-stage FL,” remarked Dr Buske.
Thus, Dr Buske et al aimed to evaluate the efficacy and safety of CT-P10 versus rituximab in patients with stage III to IV indolent B-cell lymphoma, including grades 1 to 3a FL.
Patients who achieved a complete response (CR), unconfirmed CR, or partial response (PR), received CT-P10 or rituximab maintenance for 2 years. Secondary end points included overall response rate (ORR) during the induction period per 2007 International Working Group (IWG) criteria, survival analyses, and overall safety.
From July 28, 2014 to December 29, 2015, 140 patients (70 per group) were enrolled in this randomized, double-blind, parallel-group, phase 3 trial to receive CT-P10 or rituximab with cyclophosphamide, vincristine, and prednisone every 3 week for 8 cycles.
The median follow-up was 39.9 months. Per 1999 IWG criteria, 4-year Kaplan-Meier estimates for progression-free survival (PFS; hazard ratio [HR], 1.33; 95% CI, 0.67-2.63; P=.409) for the CT-P10 arm was 61% and for the rituximab arm was 55%. The overall survival (OS; 5.29; P=.077) was 88% and 93%, respectively.
Overall, 90% of the CT-P10 arm and 86% of the rituximab arm experienced treatment-emergent adverse events (TEAEs). The long-term safety profiles were similar between groups.
“Findings confirmed favorable outcomes for CT-P10-treated patients with advanced-stage FL and demonstrate comparable long-term efficacy and overall safety between CT-P10 and rituximab,” concluded Dr Buske.—Emily Bader
