Updated results from the ZUMA-5 trial showed that treatment with axicabtagene ciloleucel resulted in significantly higher efficacy in patients with relapsed/refractory (r/r) follicular lymphoma (FL) compared with real-world treatment patterns from the SCHOLAR-5 control cohort. These results support that axicabtagene ciloleucel treatment represents a significant improvement in treatment options for these patients.
Prof. John Gribben (Barts Cancer Institute, UK) presented updated results of the ZUMA-5 study (NCT03105336), a prospective, interventional study of axicabtagene ciloleucel (axi-cel) in patients with r/r follicular lymphoma who have failed ≥2 prior lines of therapy [1]. Clinical outcomes from the ZUMA-5 cohort were compared with the international SCHOLAR-5 control cohort to provide comparative evidence in r/r follicular lymphoma patients meeting ZUMA-5 eligibility criteria.
Cross-study comparisons of a retrospective versus a prospective clinical trial may be difficult to interpret or prone to bias. Propensity score weighting was used to create balance for a broad set of prognostic covariates. The common support dataset included objective response rate, complete response, overall survival, progression-free survival (PFS), time to next treatment (TTNT), and duration of response.
The SCHOLAR-5 real-world treatment strategies were highly heterogeneous and highlighted the lack of uniform treatment options. Median follow-up was 26.2 months for SCHOLAR-5 and 23.3 months for ZUMA-5. Propensity score weighting created balance in 9 out of 10 variables (except for ECOG 0/1) versus 4 out of 10 before weighting.
Updated efficacy results showed a significantly higher efficacy of treatment in ZUMA-5 compared with SCHOLAR-5 in objective response rate (94.2% vs 49.9%; P<0.0001) and complete response (79.1% vs 29.9%; P<0.0001), favouring axi-cel treatment. Also, PFS was significantly increased in ZUMA-5 (median not reached vs 12.68 months; P<0.001; see Figure). The same was true for TTNT (median not reached vs 14.43 months; P<0.001) and overall survival (median not reached vs 59.8 months; P=0.125). Subgroup analysis of efficacy endpoints consistently confirmed overall efficacy results.
Figure: Progression-free survival in ZUMA-5 versus SCHOLAR-5 [1]
NR, not reached.
In conclusion, after applying propensity score weighting, axi-cel demonstrated better outcomes in in all clinical endpoints in the ZUMA-5 clinical trial when compared with SCHOLAR-5 findings. The substantial benefits observed in this study suggest that axi-cel addresses an important unmet medical need for r/r follicular lymphoma patients.
- Ghione P, et al. A comparison of clinical outcomes from ZUMA-5 (axicabtagene ciloleucel) and the international SCHOLAR-5 external control cohort in relapsed/refractory follicular lymphoma (r/r FL). P205-4, EHA 2021 Virtual Congress, 9–17 June.
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Table of Contents: EHA 2021
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