TY - JOUR
T1 - Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia
AU - Jabbour, Elias
AU - Zugmaier, Gerhard
AU - Agrawal, Vaibhav
AU - Martínez-Sánchez, Pilar
AU - Rifón Roca, José J.
AU - Cassaday, Ryan D.
AU - Böll, Boris
AU - Rijneveld, Anita
AU - Abdul-Hay, Maher
AU - Huguet, Françoise
AU - Cluzeau, Thomas
AU - Díaz, Mar Tormo
AU - Vucinic, Vladan
AU - González-Campos, José
AU - Rambaldi, Alessandro
AU - Schwartz, Stefan
AU - Berthon, Céline
AU - Hernández-Rivas, Jesús María
AU - Gordon, Paul R.
AU - Brüggemann, Monika
AU - Hamidi, Ali
AU - Chen, Yuqi
AU - Wong, Hansen L.
AU - Panwar, Bharat
AU - Katlinskaya, Yuliya
AU - Markovic, Ana
AU - Kantarjian, Hagop
N1 - Publisher Copyright:
© 2024 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.
PY - 2024/4
Y1 - 2024/4
N2 - Blinatumomab is a BiTE® (bispecific T-cell engager) molecule that redirects CD3+ T-cells to engage and lyse CD19+ target cells. Here we demonstrate that subcutaneous (SC) blinatumomab can provide high efficacy and greater convenience of administration. In the expansion phase of a multi-institutional phase 1b trial (ClinicalTrials.gov, NCT04521231), heavily pretreated adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) received SC blinatumomab at two doses: (1) 250 μg once daily (QD) for week 1 and 500 μg three times weekly (TIW) thereafter (250 μg/500 μg) or (2) 500 μg QD for week 1 and 1000 μg TIW thereafter (500 μg/1000 μg). The primary endpoint was complete remission/complete remission with partial hematologic recovery (CR/CRh) within two cycles. At the data cutoff of September 15, 2023, 29 patients were treated: 14 at the 250 μg/500 μg dose and 13 at 500 μg/1000 μg dose. Data from two ineligible patients were excluded. At the end of two cycles, 12 of 14 patients (85.7%) from the 250 μg/500 μg dose achieved CR/CRh of which nine patients (75.0%) were negative for measurable residual disease (MRD; <10−4 leukemic blasts). At the 500 μg/1000 μg dose, 12 of 13 patients (92.3%) achieved CR/CRh; all 12 patients (100.0%) were MRD-negative. No treatment-related grade 4 cytokine release syndrome (CRS) or neurologic events (NEs) were reported. SC injections were well tolerated and all treatment-related grade 3 CRS and NEs responded to standard-of-care management, interruption, or discontinuation. Treatment with SC blinatumomab resulted in high efficacy, with high MRD-negativity rates and acceptable safety profile in heavily pretreated adults with R/R B-ALL.
AB - Blinatumomab is a BiTE® (bispecific T-cell engager) molecule that redirects CD3+ T-cells to engage and lyse CD19+ target cells. Here we demonstrate that subcutaneous (SC) blinatumomab can provide high efficacy and greater convenience of administration. In the expansion phase of a multi-institutional phase 1b trial (ClinicalTrials.gov, NCT04521231), heavily pretreated adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) received SC blinatumomab at two doses: (1) 250 μg once daily (QD) for week 1 and 500 μg three times weekly (TIW) thereafter (250 μg/500 μg) or (2) 500 μg QD for week 1 and 1000 μg TIW thereafter (500 μg/1000 μg). The primary endpoint was complete remission/complete remission with partial hematologic recovery (CR/CRh) within two cycles. At the data cutoff of September 15, 2023, 29 patients were treated: 14 at the 250 μg/500 μg dose and 13 at 500 μg/1000 μg dose. Data from two ineligible patients were excluded. At the end of two cycles, 12 of 14 patients (85.7%) from the 250 μg/500 μg dose achieved CR/CRh of which nine patients (75.0%) were negative for measurable residual disease (MRD; <10−4 leukemic blasts). At the 500 μg/1000 μg dose, 12 of 13 patients (92.3%) achieved CR/CRh; all 12 patients (100.0%) were MRD-negative. No treatment-related grade 4 cytokine release syndrome (CRS) or neurologic events (NEs) were reported. SC injections were well tolerated and all treatment-related grade 3 CRS and NEs responded to standard-of-care management, interruption, or discontinuation. Treatment with SC blinatumomab resulted in high efficacy, with high MRD-negativity rates and acceptable safety profile in heavily pretreated adults with R/R B-ALL.
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U2 - 10.1002/ajh.27227
DO - 10.1002/ajh.27227
M3 - Article
C2 - 38317420
AN - SCOPUS:85184178324
SN - 0361-8609
VL - 99
SP - 586
EP - 595
JO - American journal of hematology
JF - American journal of hematology
IS - 4
ER -