Evidence map›Paper›PMID 35337365›Full record

ArticleExperimental hematology & oncology2022

Matching-adjusted indirect treatment comparison of chimeric antigen receptor T-cell therapies for third-line or later treatment of relapsed or refractory large B-cell lymphoma: lisocabtagene maraleucel versus tisagenlecleucel.

Guillaume Cartron, Christopher P Fox, Fei Fei Liu, Ana Kostic, Jens Hasskarl, Daniel Li, Ashley Bonner, Yixie Zhang, David G Maloney, John Kuruvilla

2 registry-linked trialsAbstract read
In one paragraph

Article in Experimental hematology & oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02445248 phase2completednot on this map

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2022Enrolled115ConditionsDiffuse Large B-cell Lymphoma (DLBCL)ArmsTisagenlecleucel, Lymphodepleting chemotherapy
NCT02631044 phase1completednot on this map

A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

TypeinterventionalSponsorJuno Therapeutics, a Subsidiary of CelgeneRan2016 to 2024Enrolled387ConditionsNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle-cell LymphomaArmsJCAR017 (lisocabtagene maraleucel) single-dose schedule, JCAR017 (lisocabtagene maraleucel) 2-dose schedule
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  11. CD8Journal for immunotherapy of cancer · 2023
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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

10 authors.

Guillaume CartronMontpellier University Hospital Center, 80 Avenue Augustin Fliche, Montpellier, France. g-cartron@chu-montpellier.fr.
Christopher P FoxNottingham University Hospitals NHS Trust, Nottingham, UK.
Fei Fei LiuBristol Myers Squibb, Princeton, NJ, USA.
Ana KosticBristol Myers Squibb, Seattle, WA, USA.
Jens HasskarlCelgene, a Bristol-Myers Squibb Company, Boudry, Switzerland.
Daniel LiBristol Myers Squibb, Princeton, NJ, USA.
Ashley BonnerEVERSANA, Burlington, ON, Canada.
Yixie ZhangEVERSANA, Burlington, ON, Canada.
David G MaloneyFred Hutchinson Cancer Research Center, Seattle, WA, USA.
John KuruvillaPrincess Margaret Cancer Centre, Toronto, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are no head-to-head clinical studies comparing chimeric antigen receptor (CAR) T-cell therapies for the treatment of relapsed or refractory aggressive large B-cell lymphomas. Naive, indirect comparisons may be inappropriate, as the study designs and patient populations could differ substantially. Matching-adjusted indirect comparisons (MAIC) can reduce many biases associated with indirect comparisons between studies. To determine the comparative efficacy and safety of lisocabtagene maraleucel (liso-cel) to tisagenlecleucel, we describe an unanchored MAIC of the pivotal studies TRANSCEND NHL 001 (TRANSCEND; NCT02631044; liso-cel) and JULIET (NCT02445248; tisagenlecleucel).

methodsIndividual patient data (IPD) from TRANSCEND were available to the authors; for the JULIET pivotal study, summary-level data from the published study were used. To balance the populations between two studies, IPD from TRANSCEND were adjusted to match the marginal distribution (e.g., mean, variance) of clinical factors among patients from JULIET.

resultsResults from the primary MAIC showed liso-cel had statistically significant greater efficacy than tisagenlecleucel (objective response rate: odds ratio [OR] = 2.78, 95% confidence interval [CI]: 1.63‒4.74; complete response rate: OR = 2.01, 95% CI: 1.22‒3.30; progression-free survival: hazard ratio [HR] = 0.65, 95% CI: 0.47‒0.91; overall survival: HR = 0.67, 95% CI: 0.47‒0.95). MAIC of safety outcomes showed lower ORs for all-grade and grade ≥ 3 cytokine release syndrome, and grade ≥ 3 prolonged cytopenia for liso-cel when compared with tisagenlecleucel; there were no statistically significant differences detected for other safety outcomes.

conclusionsOverall, this MAIC of two CAR T-cell therapies indicates liso-cel had favorable efficacy and a comparable or better safety profile relative to tisagenlecleucel. CLINICAL

trial registrationClinicalTrials.gov identifiers: NCT02631044 and NCT02445248.

Indexed as

CAR T-cell therapyIndirect treatment comparisonLisocabtagene maraleucelMatching-adjusted indirect comparisonTisagenlecleucel

Identifiers

PMID35337365
PMCPMC8953336

What OpenQuestion holds

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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.