한빛사논문
- 조회190
T.M. Kim 1, M. Taszner 2, S. Novelli 3, S.-G. Cho 4, J.C. Villasboas 5, M. Merli 6, A.J. Ubieto 7, B. Tessoulin 8, L.M. Poon 9, D. Tucker 10, J. Walewski 11, S. Yi 12, Y. Song 13, G. Chong 14, E. Bachy 15, S. Guidez 16, A. Alonso 17, D. Jagadeesh 18, W. Zhang 19, L. Magnano 20, E. Iskierka-Jażdżewska 21, M. Tani 22, B. Shen 23, A. Uppala 23, M. Zhu 23, S. Shariff 24, J. Brouwer-Visser 23, A. Chaudhry 23, H. Mohamed 23, S. Ambati 23, S. Luminari 25 on behalf of ELM-2 Investigators
1Seoul National University Hospital, Seoul, South Korea
2Department of Haematology and Transplantology, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland
3Hematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
4Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea
5Mayo Clinic, Rochester, USA
6Hematology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
7Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain
8Hematology Department, Nantes University Hospital, Nantes, France
9Hematology Oncology National University Hospital, Singapore
10Department of Hematology, Royal Cornwall Hospital, Truro, UK
11Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Warszawa, Poland
12State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China
13Department of Lymphoma, Peking University Cancer Hospital & Institute (Beijing Cancer Hospital), Beijing, China
14Department of Medical Oncology, and Clinical Haematology, Olivia Newton-John Cancer Centre, Heidelberg, Australia
15Department of Hematology, Lyon Sud Hospital, Lyon, France; Lymphoma Immuno-Biology (LIB) team, Inserm U1111, CIRI, Lyon, France
16Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers, France
17Hospital Universitario Quiron Salud Madrid, Madrid, Spain
18Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, USA
19Hematology Department, Peking Union Medical College Hospital, Beijing, China
20Hematology Department, Hospital Clínic of Barcelona, Barcelona, Spain; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
21Copernicus Memorial Hospital, Department of General Hematology, Medical University of Łódź, Łódź, Poland
22Hematology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy
23Regeneron Pharmaceuticals, Inc., Tarrytown, USA
24Regeneron UK Ltd., Uxbridge, UK
25Division of Hematology, Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy
Corresponding author: Professor Tae Min Kim
Abstract
Background
Odronextamab, a CD20×CD3 bispecific antibody that engages cytotoxic T cells to destroy malignant B cells, has demonstrated encouraging activity across multiple subtypes of relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma.
Patients and Methods
This phase II study (ELM-2; NCT03888105) evaluated odronextamab in patients with R/R follicular lymphoma (FL) after ≥2 lines of systemic therapy. Patients received intravenous odronextamab in 21-day cycles, with step-up dosing in Cycle 1 to help mitigate the risk of cytokine release syndrome (CRS), until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by independent central review.
Results
Among 128 patients evaluated, 95% completed Cycle 1, and 85% completed ≥4 cycles. At 20.1 months’ efficacy follow-up, ORR was 80.0% and complete response rate was 73.4%. Median duration of complete response was 25.1 months. Median progression-free survival was 20.7 months, and median overall survival was not reached. Discontinuation of odronextamab due to adverse events (AEs) occurred in 16% of patients. The most common treatment-emergent AEs were CRS (56%; grade ≥3 1.7% [1/60] with 0.7/4/20 mg step-up), neutropenia (39%), and pyrexia (38%).
Conclusions
Odronextamab achieved high complete response rates with generally manageable safety in patients with heavily pretreated R/R FL.
논문정보
- Research article
- 2024년 08월 (BRIC 등록일 2024-08-16)
- 국내(교신)+국외 연구진
- 의약학 > 종양의학
댓글 작성 로그인
팝업 닫기관련 링크
관련분야 연구자보기
소속기관 논문보기
관련분야 논문보기
해당논문 저자보기
