A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma

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

doi:10.1080/14737140.2023.2171994

A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma

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

Research output: Contribution to journal › Article › peer-review

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 ≥3 rd 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. .

Original language	English
Pages (from-to)	1-8
Number of pages	8
Journal	Expert Review of Anticancer Therapy
DOIs	https://doi.org/10.1080/14737140.2023.2171994
Publication status	E-pub ahead of print - 10 Feb 2023

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Manchester Cancer Research Centre

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Palomba, M. L., Ghione, P., Patel, A. R., Nahas, M., Beygi, S., Hatswell, A. J., Kanters, S., Limbrick-Oldfield, E. H., Wade, S. W., Ray, M. D., Owen, J., Neelapu, S. S., Gribben, J., Radford, J., & Bobillo, S. (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, 1-8. https://doi.org/10.1080/14737140.2023.2171994

@article{625f15ab98e944e6902b79f9edcf1f97,

title = "A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma",

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 ≥3 rd 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. .",

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

year = "2023",

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doi = "10.1080/14737140.2023.2171994",

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Palomba, ML, Ghione, P, Patel, AR, Nahas, M, Beygi, S, Hatswell, AJ, Kanters, S, Limbrick-Oldfield, EH, Wade, SW, Ray, MD, Owen, J, Neelapu, SS, Gribben, J, Radford, J & Bobillo, S 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, pp. 1-8. https://doi.org/10.1080/14737140.2023.2171994

TY - JOUR

T1 - A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma

AU - Palomba, M Lia

AU - Ghione, Paola

AU - Patel, Anik R

AU - Nahas, Myrna

AU - Beygi, Sara

AU - Hatswell, Anthony J

AU - Kanters, Steve

AU - Limbrick-Oldfield, Eve H

AU - Wade, Sally W

AU - Ray, Markqayne D

AU - Owen, Jessica

AU - Neelapu, Sattva S

AU - Gribben, John

AU - Radford, John

AU - Bobillo, Sabela

PY - 2023/2/10

Y1 - 2023/2/10

N2 - 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 ≥3 rd 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. .

AB - 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 ≥3 rd 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. .

U2 - 10.1080/14737140.2023.2171994

DO - 10.1080/14737140.2023.2171994

M3 - Article

C2 - 36723678

SP - 1

EP - 8

JO - Expert Review of Anticancer Therapy

JF - Expert Review of Anticancer Therapy

SN - 1473-7140

ER -

A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma

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