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Comparison of outcomes of patients aged ≥26 years with R/R B-ALL in ZUMA-3 and historical trials
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The phase I/II ZUMA-3 trial (NCT02614066) assessed the safety and efficacy of brexu-cel, an autologous anti-CD19 CAR T-cell therapy, in adult patients with R/R B-ALL. Results from this trial were reported previously by the ALL Hub. Here we summarize key findings from a recent publication in Leukemia & Lymphoma by Minnema et al.1 reporting the outcomes of brexu-cel vs historical SoC therapy in patients aged ≥26 years with R/R B-ALL. The SCHOLAR-3 analysis comprised three cohorts for ZUMA-3 (phase I [n = 20], phase II [n = 43], and combined phase I and II [n = 63]) matched to three SCAs (SCA-1 [n = 16], SCA-2 [n = 23], and SCA-combined [n = 39]). The MAIC analysis comprised two cohorts for ZUMA-3 (phase I and phase II) compared with three SoC cohorts, including Blina (n = 271), InO (n = 164), and Chemo pooled (n = 296).1 The endpoints were the CR/CRi rate, OS, DOR, RFS, and safety.1 |
| Key learnings |
| At a median follow-up of 26.8 months, 72% of patients in phase II achieved CR. The median OS was 25.4 months and 26.0 months, the median DOR was 12.8 months and 20 months, and the median RFS was 10.3 months and 11.6 months in phase II and combined phase I and II cohorts, respectively. |
| In the SCHOLAR-3 analysis, ZUMA-3-matched vs SCA-1 patients showed improved CR/CRi (81.3% vs 42.3%) and CR (68.8% and 38.1%). The median OS was NR and 12.1 months in ZUMA-3 vs SCA-1, 15.9 months vs 4.5 months in ZUMA-3 vs SCA-2, and 25.4 months vs 6.2 months in ZUMA-3 vs the SCA combined population. |
| The MAIC-adjusted ZUMA-3 cohort showed improved median OS vs SoC (22.4 months vs 7.7 months for ZUMA-3 vs Blina, NR vs 7.5 months for ZUMA-3 vs InO, and 22.4 months vs 5.3 months for ZUMA-3 vs chemo pooled). |
| In the ZUMA-3 phase II cohort, Grade ≥3 CRS and neurologic events and Grade 5 TEAEs were reported in 23%, 21%, and 21% of patients, respectively. |
| The findings from the ZUMA-3 trial support the use of brexu-cel vs SoC for the treatment of patients aged ≥26 years with R/R B-ALL. |
Abbreviations: B-ALL, B-cell acute lymphoblastic leukemia; blina, blinatumomab; brexu-cel, brexucabtagene autoleucel; CAR, chimeric antigen receptor; chemo, chemotherapy; CR, complete response; CRi, CR with incomplete blood count recovery; CRS, cytokine release syndrome; DOR, duration of remission; InO, inotuzumab ozogamicin; MAIC, matching-adjusted indirect comparison; NR, not reached; OS, overall survival; RFS, remission-free survival; R/R, relapsed/refractory; SCA, synthetic control arm; SoC, standard of care.
- Minnema MC, Yin X, Davi R, et al. Outcomes of patients aged ≥26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials. Leukemia & Lymphoma. 2024;65(10):1438-1447. DOI: 10.1080/10428194.2024.2353877
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