Publicaciones científicas
Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia
Elias Jabbour 1 , Gerhard Zugmaier 2 , Vaibhav Agrawal 3 , Pilar Martínez-Sánchez 4 , José J Rifón Roca 5 , Ryan D Cassaday 6 7 , Boris Böll 8 , Anita Rijneveld 9 , Maher Abdul-Hay 10 , Françoise Huguet 11 , Thomas Cluzeau 12 , Mar Tormo Díaz 13 , Vladan Vucinic 14 , José González-Campos 15 , Alessandro Rambaldi 16 , Stefan Schwartz 17 , Céline Berthon 18 , Jesús María Hernández-Rivas 19 20 21 , Paul R Gordon 22 , Monika Brüggemann 23 , Ali Hamidi 22 , Yuqi Chen 22 , Hansen L Wong 24 , Bharat Panwar 22 , Yuliya Katlinskaya 22 , Ana Markovic 22 , Hagop Kantarjian 1
Abstract
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.
CITA DEL ARTÍCULO Am J Hematol. 2024 Feb 5. doi: 10.1002/ajh.27227
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