INTRODUCTION: This double-blind, parallel-group, active-controlled phase III trial (NCT02260804) assessed CT-P10 and rituximab safety and efficacy in patients with previously untreated low-tumor-burden follicular lymphoma (LTBFL), including after a single switch from rituximab to CT-P10. PATIENTS AND METHODS: LTBFL patients were randomized (1:1) to receive CT-P10 or rituximab (375 mg/m2 intravenously; day 1 of 4 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 November 9, 2015 and January 4, 2018, 258 patients were randomized (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.

Celltrion Inc Incheon 22014 South Korea

Comprehensive Cancer Center Duarte CA 91010

Department of Hematology and Oncology Kasugai Municipal Hospital Aichi 486 8510 Japan

Department of Hematology Catholic Blood and Marrow Transplantation Center Seoul St Mary's Hospital The Catholic University of Korea Seoul 06591 South Korea

Department of Hematology Hospital Arnau de Vilanova Valencia Comunidad Valenciana 46015 Spain

Department of Hematology Nizhniy Novgorod Region Clinical Hospital Nizhniy Novgorod 603126 Russia

Department of Hematology Shinshu University School of Medicine Nagano 390 8621 Japan

Department of Internal Medicine Oncology Hematology Unit School of Medicine Universidad de la Frontera Temuco 4780000 Chile

Department of Internal Medicine Yonsei University College of Medicine Severance Hospital Seoul 03722 South Korea

Department of Medicine Charles University 128 08 Czech Republic

Department of Onco Hematology Portuguese Institute of Oncology Rua Dr Antonio Bernardino de Almeida Porto 4200 072 Portugal

Division of Hematology and Bone Marrow Transplantation N N Blokhin Russian Cancer Research Center Russian Academy of Medical Science Moscow 115478 Russia

Hematology and Oncology Department of Medicine Samsung Medical Center Sungkyunkwan University School of Medicine Seoul 06355 South Korea

Hematology Department The Catalan Institute of Oncology The Josep Carreras Leukemia Research Institute Hospital Germans Trias i Pujol Carretera Canyet Badalona 08916 Spain

Institute of Experimental Cancer Research Comprehensive Cancer Center Ulm University Hospital of Ulm 89081 Ulm Germany

Maria Sklodowska Curie National Research Institute of Oncology 331 115 Kraków Poland

N N Alexandrov Republican Scientific and Practical Centre of Oncology and Medical Radiology Lesnoy Minsk 223040 Belarus

Northern Institute for Cancer Care Newcastle University NE7 7DN UK

Russian Research Center for Radiology and Surgical Technologies Ministry of Health of the Russian Federation p Pesochny 197758 Russia

Shimane University Hospital Innovative Cancer Center Oncology Hematology Izumo Shimane 693 8501 Japan

Toni Stephenson Lymphoma Cancer Center and Department of Hematology and Hematopoietic Cell Transplantation Duarte CA 91010

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Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera® in low-tumor-burden follicular lymphoma: the FLINTER study

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ClinicalTrials.gov
NCT02260804