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FELIX trial: MRD-negative remission and clinical outcomes in R/R B-ALL treated with obe-cel
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Obecabtagene autoleucel (obe-cel) is an autologous, anti-CD19 CAR T-cell therapy that was approved by the U.S. FDA for the treatment of adults with R/R B-ALL based on promising outcomes from the FELIX trial (NCT04404660). FELIX is a phase I/II multicenter, single-arm study evaluating the safety and efficacy of obe-cel in adult patients with R/R B-ALL (N = 127 infused). The ALL hub previously reported the efficacy and safety outcomes and key results from this trial. During the 66th ASH Annual Meeting and Exposition, Jabbour presented an analysis of the correlation between depth of MRD-negative remission and clinical outcomes in patients with R/R B-ALL treated with obe-cel in the FELIX trial.1 |
| Key learnings |
| 84% of responders achieved MRD-negative remission (<10⁻⁶ leukemic cells). The median time to best MRD response was 1 month, and depth of MRD-negative remission was associated with better clinical outcomes. |
| With a median follow-up of 21.5 months, patients who achieved MRD <10⁻⁶ had significantly better EFS than those with higher ≥10⁻4 MRD, at 17.9 months vs 4.5 months, respectively. |
| MRD-negative remission was achieved across all tumor burden subgroups. Lower tumor burden at lymphodepletion (BM blast <5% vs >75%) correlated with higher MRD-negativity rates (90% vs 72.2%), EFS benefits (NE vs 11.9 months), and OS benefits (NE vs 17.1 months). |
| The results demonstrated that obe-cel induces a high incidence of MRD-negative remission (<10⁻⁶), predicting better clinical outcomes and supporting its use in adult patients with R/R B-ALL. |
Abbreviations: B-ALL, B-cell acute lymphoblastic leukemia; EFS, event-free survival; FDA, U.S. Food and Drug Administration; MRD, minimal residual disease; NE, not estimable; OS, overall survival; R/R, relapsed and refractory.
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