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Addition of venetoclax to hyper-CVAD-nelarabine-pegAsp for T-ALL/LBL: 2-year follow-up from the phase II trial
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Venetoclax is a BCL-2 inhibitor that demonstrated activity in preclinical and early-phase studies in patients with ETP-ALL/LBL. A phase II trial (NCT00501826) evaluated the outcomes of hyper-CVAD-nelarabine-pegAsp (original cohort) in adults with untreated T-ALL/LBL. In the latest protocol iteration of this trial, venetoclax was added to the induction/consolidation regimen (venetoclax cohort). The long-term results published in Leukemia by Ravandi et al.1 assessed the outcomes of adding venetoclax to the original cohort in 145 patients. The primary endpoint was the improvement in 2-year PFS and OS with venetoclax. |
| Key learnings |
| With a median follow-up of 62.4 months, 5-year PFS, DoR, and OS were 63.7%, 72.0%, and 66.2%, respectively, in the whole cohort. |
| The venetoclax cohort demonstrated higher 2-year PFS (87.9% vs 64.1%; p = 0.03) and DoR (93.6% vs 69.2%; p = 0.005) vs the original cohort. |
| The venetoclax cohort showed improved 2-year OS vs the original cohort (87.8% vs 73.9; p = 0.16). |
| Febrile neutropenia was the most common serious AE (60%); neurotoxicity and thromboembolic events were reported at lower rates (7.6% and 5.5%, respectively). |
| Overall, the promising efficacy and safety data suggest that the addition of venetoclax to hyper-CVAD-nelarabine-pegAsp could be a viable treatment option for adult patients with T-ALL/LBL. |
Abbreviations: DoR, duration of response; ETP, early T-cell precursor; hyperCVAD, hyperfractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone; LBL, lymphoblastic lymphoma; pegAsp, pegylated asparaginase; PFS, progression-free survival; OS, overall survival; T-ALL, T-cell acute lymphoblastic leukemia.
- Ravandi F, Senapati J, Jain N, et al. Longitudinal follow up of a phase 2 trial of venetoclax added to hyper-CVAD, nelarabine and pegylated asparaginase in patients with T-cell acute lymphoblastic leukemia and lymphoma. 2024. Online ahead of print. DOI: 10.3324/haematol.2024.285837
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