Repositorio
Institucional

Buske, Christian

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

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

CIG MEDIA GROUP, LP

CLINICAL LYMPHOMA MYELOMA & LEUKEMIA

en

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.

artículo original

10.1016/j.clml.2021.08.005

PDF

Biosimilar

Single switch

Time-to-event data

Therapeutic similarity

BIOSIMILAR CT-P10

MONOCLONAL-ANTIBODY

RESPONSE CRITERIA

OPEN-LABEL

DIAGNOSIS

CANCER

Oncología

Hematología

Biosimilar

Interruptor único

Datos de tiempo hasta el evento

Similitud terapéutica

BIOSIMILAR CT-P10

ANTIcuerpo MONOCLONAL

CRITERIOS DE RESPUESTA

ETIQUETA ABIERTA

DIAGNOSIS

CÁNCER

Oncología

Hematología

Otros Temas de Medicina Clínica

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

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97

artículo original

version publicada

CC BY-NC-ND 4.0

CC BY-NC-ND 4.0

acceso abierto

acceso abierto

WOS:000757000400013