Palomba, M Lia; Ghione, Paola; Patel, Anik R; Nahas, Myrna; Beygi, Sara; Hatswell, Anthony J; Kanters, Steve; ... Bobillo, Sabela; + view all Palomba, M Lia; Ghione, Paola; Patel, Anik R; Nahas, Myrna; Beygi, Sara; Hatswell, Anthony J; Kanters, Steve; Limbrick-Oldfield, Eve H; Wade, Sally W; Ray, Markqayne D; Owen, Jessica; Neelapu, Sattva S; Gribben, John; Radford, John; Bobillo, Sabela; - view fewer (2023) A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Expert Review of Anticancer Therapy 10.1080/14737140.2023.2171994. (In press).

Text A 24 month updated analysis of the comparative effectiveness of ZUMA 5 axi cel vs SCHOLAR 5 external control in relapsed refractory follicular.pdf - Accepted Version Access restricted to UCL open access staff Download (1MB)

Abstract

BACKGROUND: : In the ZUMA-5 trial, axicabtagene ciloleucel (axi-cel; an autologous anti-CD19 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 SCHOLAR-5, an external control cohort. Here 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 treated at institutions in five countries, and one historical clinical trial. All initiated a third or higher line of therapy after July 2014. ZUMA-5 eligibility criteria were applied to the SCHOLAR-5 cohort, and the groups were balanced for patient characteristics through propensity scoring on prespecified prognostic factors using standardized mortality ratio (SMR) weighting. Overall response rate was compared using weighted odds ratio. Time-to event outcomes were evaluated using weighted Kaplan-Meier analysis. RESULTS: : 143 SCHOLAR-5 patients reduced to 85 patients after SMR weighting, versus 86 patients in ZUMA-5. 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 shows that the improved efficacy of axi-cel, relative to available therapies, is durable. UNLABELLED: Clinical trials identification: www.clinicaltrials.gov. Identifier is #NCT03105336. This manuscript provides an update to a previously published analysis, using data with a longer minimum follow-up. [1].

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