Evidence map›Paper›PMID 35658525›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Three-Year Follow-Up of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma, Including High-Risk Subgroups, in the ZUMA-2 Study.

Michael Wang, Javier Munoz, Andre Goy, Frederick L Locke, Caron A Jacobson, Brian T Hill, John M Timmerman, Houston Holmes, Samantha Jaglowski, Ian W Flinn and 15 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04880434 (A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma), which is not on this map. Cited by 190 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
190citing papers in PubMed, 11 pooled it
40.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04880434 phase2completednot on this map

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)

TypeinterventionalSponsorKite, A Gilead CompanyRan2021 to 2025Enrolled95ConditionsRelapsed/Refractory Mantle Cell LymphomaArmsFludarabine, Cyclophosphamide, Brexucabtagene autoleucel
3 · Its place in the literature

Who cites it

190 citing papers in PubMed, 11 syntheses or guidelines pooled it, 297 citations in OpenAlex.

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  8. Second Primary Malignancies after CAR T-Cell Therapy: A Systematic Review and Meta-analysis of 5,517 Lymphoma and Myeloma Patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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  17. Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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130 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 18 institutions in 4 countries.

Michael WangThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-9748-5486
Javier MunozBanner MD Anderson Cancer Center, Gilbert, AZ.ORCID 0000-0002-9060-8911
Andre GoyJohn Theurer Cancer Center, Hackensack University, Hackensack, NJ.ORCID 0000-0001-5125-6522
Frederick L LockeMoffitt Cancer Center, Tampa, FL.ORCID 0000-0001-9063-6691
Caron A JacobsonDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-0180-0654
Brian T HillCleveland Clinic Foundation, Cleveland, OH.
John M TimmermanDavid Geffen School of Medicine at UCLA, Los Angeles, CA.
Houston HolmesTexas Oncology, Dallas, TX.
Samantha JaglowskiThe Ohio State University Comprehensive Cancer Center, Columbus, OH.
Ian W FlinnSarah Cannon Research Institute and Tennessee Oncology, Nashville, TN.ORCID 0000-0001-6724-290X
Peter A McSweeneyColorado Blood Cancer Institute, Denver, CO.
David B MiklosStanford University School of Medicine, Stanford, CA.ORCID 0000-0003-0717-4305
John M PagelSwedish Cancer Institute, Seattle, WA.ORCID 0000-0001-5745-8125
Marie José KerstenAmsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, the Netherlands, on behalf of HOVON/LLPC.ORCID 0000-0002-8904-3802
Krimo BouabdallahCHU Bordeaux, Service d'Hématologie et thérapie Cellulaire, Bordeaux, France.
Rashmi KhanalFox Chase Cancer Center, Philadelphia, PA.
Max S ToppMedizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.ORCID 0000-0002-1267-5289
Roch HouotCHU Rennes, Université Rennes, INSERM & EFS, Rennes, France.ORCID 0000-0003-1729-8213
Amer BeitinjanehUniversity of Miami, Miami, FL.ORCID 0000-0002-1661-5865
Weimin PengKite, a Gilead Company, Santa Monica, CA.
Xiang FangKite, a Gilead Company, Santa Monica, CA.
Rhine R ShenKite, a Gilead Company, Santa Monica, CA.
Rubina SiddiqiKite, a Gilead Company, Santa Monica, CA.ORCID 0000-0003-0244-1531
Ioana KloosKite, a Gilead Company, Santa Monica, CA.
Patrick M ReaganUniversity of Rochester Medical Center, Rochester, NY.
The University of Texas MD Anderson Cancer Center · USAmsterdam University Medical Centers · NLCentre Hospitalier Universitaire de Bordeaux · FRCleveland Clinic · USColorado Blood Cancer Institute · USDana-Farber Cancer Institute · USFox Chase Cancer Center · USHackensack University Medical Center · USInserm · FRMoffitt Cancer Center · USSarah Cannon · USStanford University · USTexas Oncology · USThe Ohio State University · USUniversitätsklinikum Würzburg · DEUniversity of California, Los Angeles · USUniversity of Miami · USUniversity of Rochester Medical Center · US

Funding

BET protein antagonist-based targeted therapy of Mantle Cell LymphomaR01CA210250 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BHALLA, KAPIL · 2017 to 2021
$1.9M
NCI NIH HHS R01 CA210250
6 · The paper itself

Abstract

purposeBrexucabtagene autoleucel (KTE-X19) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy is approved for the treatment of relapsed/refractory mantle cell lymphoma (MCL). Outcomes after a 3-year follow-up in the pivotal ZUMA-2 study of KTE-X19 in relapsed/refractory MCL are reported, including for subgroups by prior therapy (bendamustine and type of Bruton tyrosine kinase inhibitor [BTKi]) or high-risk characteristics.

methodsPatients with relapsed/refractory MCL (one to five prior therapies, including prior BTKi exposure) received a single infusion of KTE-X19 (2 × 10

resultsAfter a median follow-up of 35.6 months, the objective response rate among all 68 treated patients was 91% (95% CI, 81.8 to 96.7) with 68% complete responses (95% CI, 55.2 to 78.5); medians for duration of response, progression-free survival, and overall survival were 28.2 months (95% CI, 13.5 to 47.1), 25.8 months (95% CI, 9.6 to 47.6), and 46.6 months (95% CI, 24.9 to not estimable), respectively. Post hoc analyses showed that objective response rates and ongoing response rates were consistent among prespecified subgroups by prior BTKi exposure or high-risk characteristics. In an exploratory analysis, patients with prior bendamustine benefited from KTE-X19, but showed a trend toward attenuated T-cell functionality, with more impact of bendamustine given within 6 versus 12 months of leukapheresis. Late-onset toxicities were infrequent; only 3% of treatment-emergent adverse events of interest in ZUMA-2 occurred during this longer follow-up period. Translational assessments revealed associations with long-term benefits of KTE-X19 including high-peak CAR T-cell expansion in responders and the predictive value of minimal residual disease for relapse.

conclusionThese data, representing the longest follow-up of CAR T-cell therapy in patients with MCL to date, suggest that KTE-X19 induced durable long-term responses with manageable safety in patients with relapsed/refractory MCL and may also benefit those with high-risk characteristics.

Indexed as

Lymphoma, Mantle-CellReceptors, Chimeric AntigenAdultBendamustine HydrochlorideFollow-Up StudiesHumansImmunotherapy, AdoptiveNeoplasm Recurrence, LocalBendamustine HydrochlorideReceptors, Chimeric Antigen

Identifiers

PMID35658525
PMCPMC9870225
OpenAlexW4281901970

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.