Blinatumoab公司
医学
内科学
临床试验
不利影响
淋巴瘤
肿瘤科
耐火材料(行星科学)
淋巴母细胞淋巴瘤
白血病
淋巴细胞白血病
T细胞
免疫学
免疫系统
物理
天体生物学
作者
Nicolas Boissel,Patrice Chevallier,Vadim A Doronin,Laimonas Griskevicius,Alexey Maschan,James A. McCloskey,Alessandro Rambaldi,Giuseppe Rossi,Andrey Sokolov,Ulla Wartiovaara-Kautto,Corina Oprea,Giovanni Abbadessa,Alice Gosselin,Sandrine Macé,Xavier Thomas
摘要
The poor prognosis of acute T-cell lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in older adults and patients with relapsed/refractory illness is an unmet clinical need, as there is no defined standard of care and there are few treatment options. Abnormally elevated CD38 expression in T-ALL and T-LBL is associated with tumor expansion and disease development, making CD38 a potential target for anti-T-ALL and T-LBL treatment. Isatuximab is a monoclonal antibody that binds to a specific epitope on CD38. The purpose of the study was to assess the efficacy and safety of isatuximab monotherapy in a phase 2, multicenter, one-arm, open-label study in patients with relapsed or refractory T-ALL or T-LBL (Clinical Trials.gov identifier NCT02999633). The primary endpoint was to assess the efficacy of isatuximab by overall response rate (ORR). An interim analysis based on the efficacy and safety of isatuximab in the first 19 patients enrolled was scheduled, however only 14 patients were enrolled in the study. No patient achieved complete response (CR) or CR with incomplete peripheral recovery. Most patients (11 [78.6%]) developed progressive disease and had progressive disease as their best response. A total of 10 (71.4%) patients had treatment emergent adverse events considered treatment-related, with infusion reactions as the most frequent drug-related TEAE, occurring in 8 (57.1%) patients. Despite the low efficacy of isatuximab in the current study, it is likely that the use of immunotherapy medication in T-ALL will be expanded through logically targeted approaches, together with advances in the design of T-cell therapy and clinical experience and will provide restorative options beyond chemotherapy and targeted treatments.
科研通智能强力驱动
Strongly Powered by AbleSci AI