期刊
BLOOD ADVANCES
卷 4, 期 21, 页码 5414-5424出版社
AMER SOC HEMATOLOGY
DOI: 10.1182/bloodadvances.2020003092
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资金
- Public Health Service from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) [U24CA076518]
- National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH)
- NHLBI [U24HL138660, OT3HL147741, R21HL140314, U01HL128568, R01HL129472, R01HL130388, R01HL131731]
- NCI [U24HL138660, U24CA233032]
- Health Resources and Services Administration [HHSH250201700006C, SC1MC31881-01-00, HHSH250201700007C]
- Office of Naval Research [N00014-181-2850, N00014-18-1-2888, N00014-20-1-2705]
- NIH from NCI [P01CA111412, R01CA152108, R01CA215134, R01CA218285, R01CA231141]
- NIAID [R01AI128775, U01AI069197, U01AI126612]
- BARDA from the US Department of Health and Human Services
- Be the Match Foundation
- Boston Children's Hospital
- Dana-Farber
- Japan Hematopoietic Cell Transplantation Data Center
- St Baldrick's Foundation
- National Marrow Donor Program
- Medical College of Wisconsin
- AbbVie
- Actinium Pharmaceuticals, Inc.
- Adaptive Biotechnologies
- Adienne SA
- Allovir, Inc.
- Amgen, Inc.
- Angiocrine Bioscience
- Anthem, Inc.
- Astellas Pharma US
- AstraZeneca
- Atara Biotherapeutics, Inc.
- bluebird bio, Inc.
- Bristol-Myers Squibb Co.
- Celgene Corp.
- CSL Behring
- CytoSen Therapeutics, Inc.
- Daiichi Sankyo Co., Ltd
- Gamida-Cell, Ltd
- Genzyme
- HistoGenetics, Inc.
- Incyte Corporation
- Janssen Biotech, Inc.
- Janssen/Johnson Johnson
- Jazz Pharmaceuticals, Inc.
- Kiadis Pharma
- Kite, a Gilead Company
- Kyowa Kirin
- Legend Biotech
- Magenta Therapeutics
- Mallinckrodt LLC
- Medac GmbH
- Merck Co., Inc.
- Merck Sharp Dohme Corp.
- Millennium
- Takeda Oncology Co.
- Miltenyi Biotec, Inc.
- Novartis Oncology
- Novartis Pharmaceuticals Corp.
- Omeros Corp.
- Oncoimmune, Inc.
- OptumHealth
- Orca Biosystems, Inc.
- Pfizer, Inc.
- Pharmacyclics, LLC
- REGiMMUNE Corp.
- Sanofi Genzyme
- Shire
- Sobi, Inc.
- Takeda Pharma
- Terumo BCT
- Viracor Eurofins
- Xenikos BV
- NIH, NCI grant [K12CA087723]
Tisagenlecleucel is a CD19 chimeric antigen receptor (CAR) T-cell therapy approved for treatment of pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and adults with non-Hodgkin lymphoma (NHL). The initial experience with tisagenlecleucel in a real-world setting from a cellular therapy registry is presented here. As of January 2020, 511 patients were enrolled from 73 centers, and 410 patients had follow-up data reported (ALL, n = 255; NHL, n = 155), with a median follow-up of 13.4 and 11.9 months for ALL and NHL, respectively. Among patients with ALL, the initial complete remission (CR) rate was 85.5%. Twelve-month duration of response (DOR), event-free survival, and overall survival (OS) rates were 60.9%, 52.4%, and 77.2%, respectively. Among adults with NHL, the best overall response rate was 61.8%, including an initial CR rate of 39.5%. Six-month DOR, progression-free survival, and OS rates were 55.3%, 38.7%, and 70.7%, respectively. Grade >= 3 cytokine release syndrome and neurotoxicity were reported in 11.6% and 7.5% of all patients, respectively. Similar outcomes were observed in patients with in-specification and out-of-specification products as a result of viability <80% (range, 61% to 79%). This first report of tisagenlecleucel in the real-world setting demonstrates outcomes with similar efficacy and improved safety compared with those seen in the pivotal trials.
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