Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma Journal Article
| Authors: | Ghione, P.; Palomba, M. L.; Patel, A. R.; 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, J.; Gribben, J. G. |
| Article Title: | Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma |
| 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, outcomes from ZUMA-5 are compared with the international SCHOLAR-5 cohort, which applied key ZUMA-5 trial eligibility criteria simulating randomized controlled trial conditions. SCHOLAR-5 data were extracted from institutions in 5 countries, and from 1 historical clinical trial, for r/r FL patients who initiated a third or higher line of therapy after July 2014. Patient characteristics were balanced through propensity scoring on prespecified prognostic factors using standardized mortality ratio (SMR) weighting. Time-to-event outcomes were evaluated using weighted Kaplan-Meier analysis. Overall response rate (ORR) and complete response (CR) rate were compared using weighted odds ratios. The 143 ScHOLAR-5 patients reduced to an effective sample of 85 patients after SMR weighting vs 86 patients in ZUMA-5. Median follow-up time was 25.4 and 23.3 months for SCHOLAR-5 and ZUMA-5. Median overall survival (OS) and progression-free survival (PFS) in SCHOLAR-5 were 59.8 months and 12.7 months and not reached in ZUMA-5. 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 and 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 with available therapies, axi-cel demonstrated an improvement in meaningful clinical endpoints, suggesting axi-cel addresses an important unmet need for r/r FL patients. This trial was registered at www.clinicaltrials.gov as #NCT03105336. © 2022 American Society of Hematology |
| Keywords: | adult; cancer survival; controlled study; major clinical study; overall survival; cancer recurrence; drug efficacy; monotherapy; cancer radiotherapy; outcome assessment; positron emission tomography; follow up; progression free survival; cohort studies; randomized controlled trial; cohort analysis; pathology; cell therapy; lymphoma, large b-cell, diffuse; follicular lymphoma; lymphoma, follicular; adoptive immunotherapy; immunotherapy, adoptive; cd19 antigen; antigens, cd19; adverse event; comparative effectiveness; overall response rate; diffuse large b cell lymphoma; cancer prognosis; idelalisib; humans; human; male; female; article; standardized mortality ratio; x-ray computed tomography; axicabtagene ciloleucel; patient history of stem cell transplantation |
| Journal Title: | Blood |
| Volume: | 140 |
| Issue: | 8 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2022-08-25 |
| Start Page: | 851 |
| End Page: | 860 |
| Language: | English |
| DOI: | 10.1182/blood.2021014375 |
| PUBMED: | 35679476 |
| PROVIDER: | scopus |
| PMCID: | PMC9412012 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 3 October 2022 -- Source: Scopus |
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