@article{1ceacb98fe644d419f53ce8547c52a3a,
title = "Comparison of 2-year outcomes with CAR T cells (ZUMA-1) vs salvage chemotherapy in refractory large B-cell lymphoma",
abstract = "The SCHOLAR-1 international retrospective study highlighted poor clinical outcomes and survival among patients with refractory large B-cell lymphoma (LBCL) treated with conventional chemotherapy. Axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, demonstrated durable responses in patients with refractory LBCL in the pivotal phase 1/2 ZUMA-1 study (NCT02348216). Here, we compared SCHOLAR-1 with the 2-year outcomes of ZUMA-1. Prior to comparison of clinical outcomes, propensity scoring (based on a broad set of prognostic covariates) was used to create balance between ZUMA-1 and SCHOLAR-1 patients. In the pivotal phase 2 portion of ZUMA-1, 101 patients received axi-cel and were evaluable for response and survival. In SCHOLAR-1, 434 and 424 patients were evaluable for response and survival, respectively. ZUMA-1 patients were more heavily pretreated than were SCHOLAR-1 patients. The median follow-up was 27.1 months in ZUMA-1. The objective response rate (ORR) and complete response rate were 83% and 54% in ZUMA-1 vs 34% and 12% in SCHOLAR-1, respectively. The 2-year survival rate was 54% in ZUMA-1 and 20% in SCHOLAR-1, and a 73% reduction in the risk of death was observed in ZUMA-1 vs SCHOLAR-1. These results were consistent with those of an additional standardization analysis in which strata were limited to 2 prognostic factors (refractory categorization and presence/absence of stem cell transplant after refractoriness to chemotherapy) to conserve sample size. Despite the limitations of a nonrandomized analysis, these results indicate that axi-cel produces durable responses and a substantial survival benefit vs non-CAR T-cell salvage regimens for patients with refractory LBCL.",
author = "Neelapu, {Sattva S.} and Locke, {Frederick L.} and Bartlett, {Nancy L.} and Lekakis, {Lazaros J.} and Reagan, {Patrick M.} and Miklos, {David B.} and Jacobson, {Caron A.} and Ira Braunschweig and Oluwole, {Olalekan O.} and Tanya Siddiqi and Yi Lin and Michael Crump and John Kuruvilla and {van Den Neste}, Eric and Umar Farooq and Lynn Navale and Venita DePuy and Kim, {Jenny J.} and Christian Gisselbrecht",
note = "Funding Information: This work was supported by Kite, a Gilead Company. Medical writing support was provided by Ashley Skorusa (Nexus Global Group Science, LLC) and funded by Kite, a Gilead Company. Funding Information: Conflict-of-interest disclosure: S.S.N. has received personal fees from Kite, a Gilead Company, Merck, Bristol Myers Squibb, Novartis, Celgene, Pfizer, Allogene Therapeutics, Cell Medica/Kuur, Incyte, Precision Biosciences, Legend Biotech, Adicet Bio, Calibr, and Unum Therapeutics; has received research support from Kite, a Gilead Company, Bristol Myers Squibb, Merck, Poseida Therapeutics, Cellectis, Celgene, Karus Therapeutics, Unum Therapeutics, Allogene Therapeutics, Precision Biosciences, and Acerta; has received royalties from Takeda Pharmaceuticals; and holds intellectual property related to cell therapy. F.L.L. has served as an advisor for Kite, a Gilead Company, Novartis, Celgene/Bristol Myers Squibb, Amgen, Calibr, Gam-maDelta Therapeutics, Wugen, and Allogene; has served as a consultant with grant options for Cellular Biomedicine Group, Inc; and has received research funding from Kite, a Gilead Company. His employer holds patents in his name with regard to improvements to CAR T-cell therapy. N.L.B. has served as an advisor for Acerta, ADC Therapeutics, BTG, Seattle Genetics, and Roche/Genentech and has received research funding from Affimed, Bristol Myers Squibb, Celgene, Forty Seven, Genentech, Janssen, Immune Design, Kite, a Gilead Company, Merck, Millennium, Pharmacyclics, Pfizer, and Seattle Genetics. P.M.R. has served as a consultant or advisor for Kite, a Gilead Company, and Curis and has received research funding from Seattle Genetics. D.B.M. has served as a consultant or advisor for Kite-Gilead, Novartis, Juno-Celgene-Bristol Myers Squibb, Adaptive Biotech, Pharmacyclics, and Janssen; has received research funding from Kite-Gilead, Novartis, Juno-Celgene-Bristol Myers Squibb, Adaptive Biotech, and Pharmacyclics; has received patents, royalties, or other intellectual property from Pharmacyclics; and has received travel support from Kite-Gilead, Novartis, Juno-Cel-gene-Bristol Myers Squibb, Adaptive Biotech, Pharmacyclics, and Publisher Copyright: {\textcopyright} 2021 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.",
year = "2021",
month = oct,
day = "26",
doi = "10.1182/bloodadvances.2020003848",
language = "English",
volume = "5",
pages = "4149--4155",
journal = "Blood advances",
issn = "2473-9529",
number = "20",
}