Ghione P, Palomba ML, Patel A, et al. Comparative Effectiveness of ZUMA-5 (Axi-Cel) vs SCHOLAR-5 External Control in Relapsed/Refractory Follicular Lymphoma. Blood. 2022; (doi: 10.1182/blood.2021014375).
New research shows that axicabtagene ciloleucel (axi-cel) led to an improvement in key clinical endpoints in relapsed/refractory (r/r) follicular lymphoma (FL), compared with available therapies. In the ZUMA-5 trial, the autologous anti-CD19 chimeric antigen receptor T-cell therapy demonstrated high rates of durable response against r/r FL. In this study, clinical outcomes from ZUMA-5 were compared with the SCHOLAR-5 external control cohort, which used ZUMA-5 trial eligibility criteria to reproduce randomized controlled trial conditions. Researchers extracted SCHOLAR-5 data from institutions in five countries for r/r FL patients who initiated a ≥3rd line of therapy after July 2014. Of the 143 patients identified in SCHOLAR-5, 85 were selected following standardized mortality ratio weighting, compared with 86 patients in ZUMA-5. The median follow-up times for the two trials were 25.4 and 23.3 months, respectively. SCHOLAR-5 patients saw a median overall survival (OS) and progression-free survival (PFS) of 59.8 months and 12.7 months, respectively; these rates were not reached in ZUMA-5. The hazard ratios for OS and PFS were 0.42 and 0.30, respectively. The SCHOLAR-5 cohort's overall response rate and complete response were 49.9% and 29.9%, compared with a respective 94.2% and 79.1% in ZUMA-5. "This study suggests axi-cel may address an important unmet need for r/r FL patients," the researchers conclude.