Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma : Final Results of a Randomized Phase III Study
Kwak, Larry W. (Comprehensive Cancer Center, Duarte)
Sancho, Juan Manuel (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Cho, Seok Goo (The Catholic University of Korea, Seoul, South Korea)
Nakazawa, Hideyuki (Shinshu University School of Medicine, Nagano, Japan)
Suzumiya, Junji (Shimane University Hospital, Innovative Cancer Center/Oncology-Hematology, Izumo, Japan)
Tumyan, Gayane (Division of Hematology and Bone Marrow Transplantation, Blokhin Russian Cancer)
Kim, Jin Seok (Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea)
Menne, Tobias (Newcastle University, UK)
Mariz, José (Instituto Português de Oncología do Porto)
Ilyin, Nikolai (Ministry of Health of the Russian Federation)
Jurczak, Wojciech (Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, Poland)
Lopez Martinez, Aurelio (Hospital Arnau de Vilanova (València))
Samoilova, Olga (Nizhniy Novgorod Region Clinical Hospital, Nizhniy Novgorod, Russia)
Zhavrid, Edvard (N. N. Alexandrov Republican Scientific and Practical Centre of Oncology and Medical Radiology, Belarus)
Yañez Ruiz, Eduardo (Universidad de la Frontera, Temuco, Chile)
Trneny, Marek (Charles University, Czech Republic)
Popplewell, Leslie (Toni Stephenson Lymphoma Cancer Center and Department of Hematology and Hematopoietic Cell Transplantation, Duarte, CA)
Ogura, Michinori (Kasugai Municipal Hospital, Aichi 486-8510, Japan.)
Kim, Wong Seog (Sungkyunkwan University School of Medicine, Seoul, South Korea)
Lee, Sang Joon (Celltrion. Inc, South Korea)
Kim, Sung Hyun (Celltrion. Inc, South Korea)
Ahn, Keum Young (Celltrion. Inc, South Korea)
Buske, Christian (University Hospital of Ulm, Germany)

Data:	2022
Resum:	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 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Biosimilar ; Single switch ; Time-to-event data ; Therapeutic similarity
Publicat a:	Clinical Lymphoma, Myeloma & Leukemia, Vol. 22 Núm. 2 (february 2022) , p. 89-97, ISSN 2152-2669

DOI: 10.1016/j.clml.2021.08.005

9 p, 821.4 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Institut de Recerca contra la Leucèmia Josep Carreras
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