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Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma
Journal article   Open access   Peer reviewed

Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma

Gilles Salles, Stephen J. Schuster, Martin Dreyling, Luca Fischer, John Kuruvilla, Piers E.M. Patten, Bastian von Tresckow, Sonali M. Smith, Ana Jiménez-Ubieto, Keith L. Davis, …
Blood advances, Vol.6(22), pp.5835-5843
08/19/2022
DOI: 10.1182/bloodadvances.2022008150
PMCID: PMC9649992
PMID: 35973192
url
https://doi.org/10.1182/bloodadvances.2022008150View
Published (Version of record) Open Access

Abstract

Image 1 The ELARA trial indicates tisagenlecleucel (tisa-cel) is an effective anti-CD19 chimeric antigen receptor T-cell therapy for relapsed or refractory follicular lymphoma (r/r FL). As ELARA is a single-arm trial, this study compares tisa-cel outcomes from the ELARA trial with usual care from a real-world cohort. ELARA enrolled 98 patients as of 29 March 2021 (median follow-up: 15 months from enrollment). Usual care data were obtained from ReCORD-FL, a global retrospective study of patients with r/r FL, who met similar eligibility criteria to ELARA. With a data cutoff date of 31 December 2020, 187 patients with ≥2 preceding treatment lines were included in the ReCORD-FL (median follow-up: 57 months from third-line) study. An indirect treatment comparison was performed for 97 patients from the ELARA trial and 143 patients from the ReCORD-FL study with no missing data on baseline factors. The line of therapy for which outcomes were assessed was selected or matched between cohorts using propensity score modeling. After baseline factor adjustment via weighting by odds, complete response rate (CRR; 95% confidence interval) was 69.1% (59.8%-78.3%) for tisa-cel vs. 37.3% (26.4%-48.3%) for usual care; overall response rate was 85.6% (78.7%-92.5%) vs. 63.6% (52.5%-74.7%). Kaplan-Meier probability of being progression/event-free at 12 months was 70.5% (61.4%-79.7%) for tisa-cel vs. 51.9% (40.6%-63.3%) for usual care, with hazard ratio (HR)=0.60 (0.34-0.86); 12-month overall survival was 96.6% (92.9%-100%) vs. 71.7% (61.2%-82.2%), with HR=0.2 (0.02-0.38). In conclusion, tisa-cel was associated with a 1.9-fold higher complete response rate and a 1.4-fold higher rate of being progression or event free at 12 months vs usual care, as well as a death risk reduction of 80%. The findings provide additional evidence on the benefit of tisa-cel in patients with r/r FL after ≥2 treatment lines. This trial was registered at www.clinicaltrials.gov as NCT03568461 • Our study contextualizes the single-arm ELARA trial by providing historical control data from clinically similar patients on usual care. • Tisagenlecleucel was shown to have superior efficacy than usual care in patients with multiply relapsed or refractory follicular lymphoma.
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