Repositorio UFRO · Omeka S

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

Primer Autor	Buske, Christian
Co-autores	Kwak, Larry W. Sancho, Juan-Manuel Cho, Seok-Goo Nakazawa, Hideyuki Suzumiya, Junji Tumyan, Gayane Kim, Jin Seok Menne, Tobias Mariz, Jose Ilyin, Nikolai Jurczak, Wojciech Lopez Martinez, Aurelio Samoilova, Olga Zhavrid, Edvard Yanez Ruiz, Eduardo Trneny, Marek Popplewell, Leslie Ogura, Michinori Kim, Won-Seog Lee, Sang Joon Kim, Sung Hyun Ahn, Keum Young
Título	Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study
Editorial	CIG MEDIA GROUP, LP
Revista	CLINICAL LYMPHOMA MYELOMA & LEUKEMIA
Lenguaje	en
Resumen	We assessed the efficacy and safety of rituximab and its biosimilar, CT-P10, in treatment-naive low-tumor-burden follicular lymphoma patients, with a median follow-up of 29.2 months. Data from the trial show that the efficacy and safety of rituximab and CT-P10 were similar, including after a single switch from rituximab to CT-P10. These data support the therapeutic similarity of rituximab and CT-P10. 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/m(2) 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) dur ing 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. (C) 2021 The Authors. Published by Elsevier Inc.
Tipo de Recurso	artículo original
doi	10.1016/j.clml.2021.08.005
Formato Recurso	PDF
Palabras Claves	Biosimilar Single switch Time-to-event data Therapeutic similarity BIOSIMILAR CT-P10 MONOCLONAL-ANTIBODY RESPONSE CRITERIA OPEN-LABEL DIAGNOSIS CANCER
Ubicación del archivo	http://dx.doi.org/10.1016/j.clml.2021.08.005
Categoría OCDE	Oncología Hematología
Materias	Biosimilar Interruptor único Datos de tiempo hasta el evento Similitud terapéutica BIOSIMILAR CT-P10 ANTIcuerpo MONOCLONAL CRITERIOS DE RESPUESTA ETIQUETA ABIERTA DIAGNOSIS CÁNCER
Disciplinas de la OCDE	Oncología Hematología Otros Temas de Medicina Clínica
Versión del recurso (Recomendado-único)	version publicada
Tipo de ruta	hibrida verde
Access Rights	acceso abierto
Derechos de acceso	acceso abierto
Id de Web of Science	WOS:000757000400013
Título de la cita (Recomendado-único)	Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study
Página de inicio (Recomendado-único)	89
Página final (Recomendado-único)	97
Identificador del recurso (Mandatado-único)	artículo original
License	CC BY-NC-ND 4.0
Condición de la licencia (Recomendado-repetible)	CC BY-NC-ND 4.0