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Clinical Trial
. 2022 Mar;11(5):1292-1298.
doi: 10.1002/cam4.4478. Epub 2022 Feb 2.

Isatuximab monotherapy in patients with refractory T-acute lymphoblastic leukemia or T-lymphoblastic lymphoma: Phase 2 study

Nicolas Boissel  1 , Patrice Chevallier  2 , Vadim Doronin  3 , Laimonas Griskevicius  4 , Alexey Maschan  5 , James McCloskey  6 , Alessandro Rambaldi  7 , Giuseppe Rossi  8 , Andrey Sokolov  9 , Ulla Wartiovaara-Kautto  10 , Corina Oprea  11 , Giovanni Abbadessa  12 , Alice Gosselin  11 , Sandrine Macé  11 , Xavier Thomas  13
Affiliations
Clinical Trial

Isatuximab monotherapy in patients with refractory T-acute lymphoblastic leukemia or T-lymphoblastic lymphoma: Phase 2 study

Nicolas Boissel et al. Cancer Med. 2022 Mar.

Abstract

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.

Keywords: T lymphoblastic lymphoma; acute lymphoblastic leukemia; isatuximab; monoclonal antibodies; monotherapy.

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Conflict of interest statement

Nicolas Boissel: reports personal fees from Sanofi. Alessandro Rambaldi: reports advisory board, personal fees and non‐financial support from Amgen, Celgene, Gilead, Italofarmaco, Jazz, Novartis, Pfizer and Roche. Giuseppe Rossi: reports personal fees from Sanofi. Andrey Sokolov: reports grants, personal fees and non‐financial support from Amgen, Novartis and Pfizer, grant and non‐financial support from Astellas. Ulla Wartiovaara‐Kautto: reports personal fees from Celgene, Pfizer and Sanofi. Giovanni Abbadessa, Alice Gosselin, Corina Oprea, Sandrine Macé: are employees of Sanofi and may hold shares and/or stock options in the company. Patrice Chevallier, Vadim Doronin, Laimonas Griskevicius, Alexey Maschan, James McCloskey, Xavier Thomas: have nothing to disclose.

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