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- Title
ABCL-166: Tisagenlecleucel and Lisocabtagene Maraleucel: Comparative Efficacy in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.
- Authors
Schuster, Stephen J.; Jie Zhang; Hongbo Yang; Agarwal, Abhijit; Wenxi Tang; Prieto, Marcela Martinez; Bollu, Vamsi; Kuzan, David; Maziarz, Richard; Kersten, Marie José
- Abstract
Tisagenlecleucel and liso-cel are effective chimeric antigen receptor T-cell therapies for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). However, there have been no head-to-head randomized controlled trials. Compare efficacy of tisagenlecleucel and liso-cel in R/R DLBCL using matching-adjusted indirect comparison (MAIC). Individual patient-level data (IPD) from JULIET (tisagenlecleucel; NCT02445248; 02/2020 data cut) were weighted to match the population in TRANSCEND (liso-cel; NCT02631044; 08/2019 data cut). 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 rate (CRR), and overall response rate (ORR) were compared. Primary analyses compared JULIET infused patients (N=106, excluding 8 without lymphodepleting chemotherapy [LDC] and 1 large-cell neuroendocrine carcinoma) with TRANSCEND efficacy-evaluable patients (N=256, infused patients). A scenario analysis compared JULIET infused to TRANSCEND primary analysis set (PAS) (N=133, dose level 2, excluding ECOG PS 2, prior alloSCT, 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. MAIC cannot adjust for between-trial differences in adverse event management; therefore, safety outcomes were not compared. OS (HR: 1.12; 95%CI: 0.62–2.05, P=0.71), PFS (HR: 1.16; 95%CI: 0.64–2.09; P=0.63), and CRR difference (–5.4%; 95%CI: –15.5%–4.7%; P=0.29) were comparable for tisagenlecleucel-infused patients and the liso-cel efficacy-evaluable set after adjusting for differences in baseline characteristics. Results were consistent across all scenario and sensitivity analyses. ORR trended higher in the TRANSCEND efficacy-evaluable set (72.7% vs 62.9%, P=0.07) and was higher in TRANSCEND PAS versus the matched JULIET infused set (74.4% vs 60.9%, P<0.05). MAIC results indicate there is no evidence of differences in OS, PFS, and CRR between tisagenlecleucel and liso-cel in R/R DLBCL. These findings should be confirmed using IPD from both trials and/or real-world evidence. The study was funded by Novartis.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2021, Vol 21, pS380
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/S2152-2650(21)01867-X