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Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study

Lookup NU author(s): Dr Tobias Menne

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Abstract

© 2021 The AuthorsIntroduction: 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.

Publication metadata

Author(s): Kwak LW, Sancho J-M, Cho S-G, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Menne T, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Ogura M, Kim W-S, Lee SJ, Kim SH, Ahn KY, Buske C

Publication type: Article

Publication status: Published

Journal: Clinical Lymphoma, Myeloma and Leukemia

Year: 2022

Volume: 22

Issue: 2

Pages: 89-97

Print publication date: 15/02/2022

Online publication date: 28/08/2021

Acceptance date: 22/08/2021

Date deposited: 10/11/2021

ISSN (print): 2152-2650

ISSN (electronic): 2152-2669

Publisher: Elsevier Inc.

URL: https://doi.org/10.1016/j.clml.2021.08.005

DOI: 10.1016/j.clml.2021.08.005

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