A 24-Month Updated Analysis of the Comparative Effectiveness of Zuma-5 (Axi-Cel) vs. Scholar-5 External Control in Relapsed/Refractory Follicular Lymphoma

Authors

M Lia Palomba
Paola Ghione
Anik R Patel
Myrna Nahas
Sara Beygi
Anthony J Hatswell
Steve Kanters
Eve H Limbrick-Oldfield
Sally W Wade
Markqayne D Ray
Jessica Owen
Sattva S Neelapu
John Gribben
John Radford
Sabela Bobillo

Publication Date

2-1-2023

Journal

Expert Review of Anticancer Therapy

Abstract

Background: In the ZUMA-5 trial (Clinical trials identification: NCT03105336), axicabtagene ciloleucel (axi-cel; a chimeric antigen receptor T-cell therapy) demonstrated high rates of durable response in relapsed/refractory (r/r) follicular lymphoma (FL) patients and clear superiority relative to the SCHOLAR-5 external control cohort. We update this comparison using the ZUMA-5 24-month data.

Research design and methods: The SCHOLAR-5 cohort is comprised of r/r FL patients who initiated ≥3rd line of therapy after July 2014 and meeting ZUMA-5 eligibility criteria. Groups were balanced for patient characteristics through propensity scoring on prespecified prognostic factors using standardized mortality ratio (SMR) weighting. The overall response rate was compared using a weighted logistic regression. Time-to-event outcomes were evaluated using a Cox regression.

Results: For SCHOLAR-5, the sum of weights for the 143 patients was 85 after SMR weighting, versus 86 patients in ZUMA-5. The median follow-up was 29.4 months and 25.4 months for ZUMA-5 and SCHOLAR-5, respectively. The hazard ratios for overall survival and progression-free survival were 0.52 (95% confidence interval (CI): 0.28-0.95) and 0.28 (95% CI: 0.17-0.45), favoring axi-cel.

Conclusion: This updated analysis, using a longer minimum follow-up than a previously published analysis, shows that the improved efficacy of axi-cel, relative to available therapies, in r/r FL is durable.

Keywords

Humans, Lymphoma, Follicular, Immunotherapy, Adoptive, Progression-Free Survival, Lymphoma, Large B-Cell, Diffuse, Biological Products, Follicular lymphoma, ZUMA-5, axicabtagene ciloleucel, comparative effectiveness, propensity score analysis

DOI

10.1080/14737140.2023.2171994

PMID

36723678

PMCID

PMC11104735

PubMedCentral® Posted Date

5-20-2024

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes