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Obecabtagene autoleucel in adult patients with R/R B-ALL: Results from FELIX trial
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Obe-cel is an autologous, anti-CD19 CAR T-cell therapy approved for the treatment of adults with R/R B-ALL. This approval was based on results from the FELIX trial (NCT04404660). Results from this study were published in The New England Journal of Medicine by Roddie et al.1 The primary endpoint was overall remission in the II A cohort.1 |
| Key learnings |
| After a median follow-up of 20.3 months, the overall remission, CR, and CR/CRi rates were 77%, 55%, and 21%, respectively. |
| Median EFS was 11.9 months; estimated 6-month and 12-month EFS were 65.4% and 49.5%. The median OS was 15.6 months; estimated 6-month and 12-month OS were 80.3% and 61.1%. |
| CRS and ICANS were reported in 69% and 23% of patients; Grade ≥3 CRS and ICANS were 2.4% and 7.1%. |
| Results from the FELIX trial support the use of obe-cel in adult patients with R/R B-ALL. |
Abbreviations: B-ALL, B-cell acute lymphoblastic leukemia; CAR, chimeric antigen receptor; CR, complete remission; CRi, CR with incomplete hematologic recovery; CRS, cytokine release syndrome; EFS, event-free survival; ICANS, immune effector cell-associated neurotoxicity; obe-cel, obecabtagene autoleucel; OS, overall survival; R/R, relapsed/refractory.
- Roddie C, Sandhu KS, Tholouli E, et al. Obecabtagene autoleucel in adults with B-cell acute lymphoblastic leukemia. N Eng J Med. 2024. Online ahead of print. DOI: 10.1056/NEJMoa2406526
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