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    Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma

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    Authors
    Ghione, P.
    Palomba, M. L.
    Patel, A.
    Bobillo, S.
    Deighton, K.
    Jacobson, C. A.
    Nahas, M.
    Hatswell, A. J.
    Jung, A. S.
    Kanters, S.
    Snider, J. T.
    Neelapu, S. S.
    Ribeiro, M. T.
    Brookhart, M. A.
    Ghesquieres, H.
    Radford, John A
    Gribben, J. G.
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    Affiliation
    Memorial Sloan Kettering Cancer Center, New York, NY, United States
    Issue Date
    2022
    
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    Abstract
    In the pivotal 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. Here, clinical outcomes from ZUMA-5 are compared to the international SCHOLAR-5 external control cohort, which applied ZUMA-5 trial eligibility criteria to emulate RCT conditions. SCHOLAR-5 data were extracted from institutions in five countries for r/r FL patients who initiated a ≥3rd line of therapy after July 2014. Patient characteristics were balanced through propensity scoring on pre-specified prognostic factors using standardized mortality ratio (SMR) weighting. Time-to-event outcomes were evaluated using Kaplan-Meier analysis. Overall response rate (ORR) and complete response (CR) rate were compared using odds ratios. The 143 patients identified in SCHOLAR-5 reduced to an effective sample of 85 patients after SMR weighting, versus 86 patients in ZUMA-5. Median follow-up time was 25.4 and 23.3 months for SCHOLAR-5 and ZUMA-5. The median overall survival (OS) and progression-free survival (PFS) in SCHOLAR-5 were 59.8 months and 12.7 months, and were not reached in ZUMA-5. The hazard ratios for OS and PFS were 0.42 (95% confidence interval [CI]: 0.21-0.83) and 0.30 (95%CI: 0.18-0.49). The ORR and CR rate were 49.9% and 29.9% in SCHOLAR-5 compared to 94.2% and 79.1% in ZUMA-5, for odds ratios of 16.2 (95%CI: 5.6-46.9) and 8.9 (95%CI: 4.3-18.3). Compared to available therapies, axi-cel demonstrated an improvement in meaningful clinical endpoints. This study suggests axi-cel may address an important unmet need for r/r FL patients.
    Citation
    Ghione P, Palomba ML, Patel A, Bobillo S, Deighton K, Jacobson CA, et al. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Blood. American Society of Hematology; 2022.
    Journal
    Blood
    URI
    http://hdl.handle.net/10541/625362
    DOI
    10.1182/blood.2021014375
    PubMed ID
    35679476
    Additional Links
    https://dx.doi.org/10.1182/blood.2021014375
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1182/blood.2021014375
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