Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumour-Burden Follicular Lymphoma: Final Results of a Randomised Phase 3 Study

Abstract Purpose: This double-blind, parallel-group, active-controlled phase 3 trial (NCT02260804) assessed CT-P10 and rituximab safety and efficacy in patients with previously untreated low-tumour-burden follicular lymphoma (LTBFL), including after a single switch from rituximab to CT-P10. Patients and Methods: LTBFL patients were randomised (1:1) to receive CT-P10 or rituximab (375 mg/m2 intravenously; day 1 of four 7-day cycles). Patients achieving disease control entered a 2-year maintenance period. CT-P10 or rituximab were administered every 8 weeks (6 cycles) in year 1; all patients could receive CT-P10 (every 8 weeks; 6 cycles) in year 2. Secondary endpoints (reported here) were overall response rate (ORR) during the study period, progression-free survival (PFS), time to progression (TTP), and overall survival (OS). Safety and immunogenicity were evaluated. Results: Between 9 November 2015 and 4 January 2018, 258 patients were randomised (130 for CT-P10; 128 for rituximab). ORR was similar between groups over the study period (CT-P10: 88%; rituximab: 87%). After 29.2 months’ median follow-up, median PFS, TTP and OS were not estimable; 24-month Kaplan-Meier estimates suggested similarity between groups. Overall, 114 (CT-P10: 88%) and 104 (rituximab: 81%) patients experienced treatment-emergent adverse events. The single switch was well tolerated. Conclusion: These updated data support therapeutic similarity of CT-P10 and rituximab and support the use of CT-P10 monotherapy for previously untreated LTBFL.