Comparative efficacy of tisagenlecleucel (tisa-cel) and lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).

Authors

null

Stephen J. Schuster

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA

Stephen J. Schuster , Jie Zhang , Hongbo Yang , Abhijit Agarwal , Wenxi Tang , Marcela Martinez-Prieto , Vamsi Bollu , Qiufei Ma , David Kuzan , Richard T. Maziarz , Marie José Kersten

Organizations

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Analysis Group, Inc., Boston, MA, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands

Research Funding

Pharmaceutical/Biotech Company
Novartis Pharmaceutical Corporation

Background: Chimeric antigen receptor T-cell therapies tisa-cel and liso-cel are effective treatments for r/r DLBCL (Schuster 2019, Abramson 2020). This study compared efficacy outcomes of tisa-cel and liso-cel in r/r DLBCL using matching-adjusted indirect comparison (MAIC). Methods: Individual patient-level data (IPD) from JULIET (tisa-cel; NCT02445248; 02/2020 datacut) were weighted to match the patient population in TRANSCEND (liso-cel; NCT02631044; 08/2019 datacut). Baseline prognostic factors available in both trials were adjusted for age, sex, histology, ECOG performance status [ECOG PS], left ventricular ejection fraction, radiologic sum of product diameters, lactate dehydrogenase, prior stem cell transplantation [SCT], use of bridging therapy, and number of and refractoriness to prior therapies, in the MAIC. Overall survival (OS), progression-free survival (PFS), complete response (CR) rate, and overall response (OR) rate were compared. Primary analyses compared infused patients in JULIET (N=106, excluding 8 without lymphodepleting chemotherapy [LDC] and 1 large cell neuroendocrine carcinoma) with efficacy-evaluable set in TRANSCEND (N=256, infused patients). A scenario analysis compared JULIET infused to TRANSCEND primary analysis set (PAS) (N=133, dose level 2, excluding those with ECOG PS 2, prior allogeneic SCT, primary mediastinal B-cell lymphoma, follicular lymphoma [FL] 3B, or transformation from indolent lymphoma besides FL). Sensitivity analyses included JULIET patients with only fludarabine-based LDC or only adjusted significantly different baseline prognostic factors. Safety outcomes were not compared because adverse event management has evolved and differed between the two trials; MAIC is unable to adjust for such differences. Results: After adjusting for differences in baseline characteristics, OS, PFS, and CR were comparable between tisa-cel infused patients and the liso-cel efficacy-evaluable set (Table). The results were consistent across all scenario and sensitivity analyses. OR rate trended higher in the TRANSCEND efficacy-evaluable set (72.7% vs. 62.9%, p=0.07) and was higher in TRANSCEND PAS than in the respectively matched JULIET infused set (74.4% vs. 60.9%, p < 0.05). Conclusions: The MAIC results indicate there is no evidence suggesting differences in OS, PFS and CR between tisa-cel and liso-cel in r/r DLBCL. Analyses using IPD from both trials and/or real-world evidence are warranted to confirm these findings.

MAIC of Tisa-cel Infused vs. Liso-cel Efficacy-evaluable set.

Tisa-cel vs. liso-cel (95% CI); p-value
OS, hazard ratio (HR)
1.12 (0.62, 2.05); p=0.71;

1-year OS rate: 55.1% vs 57.9%
PFS, HR
1.16 (0.64, 2.09); p=0.63;

1-year PFS rate: 47.4% vs 44.1%
CR, rate difference
-5.4% (-15.5%, 4.7%); p=0.29
OR, rate difference
-9.7% (-20.0%, 0.6%); p=0.07

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Non-Hodgkin Lymphoma

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 7535)

DOI

10.1200/JCO.2021.39.15_suppl.7535

Abstract #

7535

Poster Bd #

Online Only

Abstract Disclosures