Safety and Pharmacokinetics of Subcutaneous Blinatumomab (SC blinatumomab) for the Treatment of Adults with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL); Results from a Phase 1b Study

Sánchez, Pilar Martínez; Zugmaier, Gerhard; Gordon, Paul; Jabbour, Elias; Roca, José J. Rifón; Schwartz, Stefan; Borlenghi, Erika; Huguet, Françoise; Hernández‐Rivas, Jesús María; Lussana, Federico; Berthon, Céline; Kadu, Priti; Wong, Hansen; Marković, Ana; Katlinskaya, Yuliya

doi:10.1182/blood-2022-157117

Cited by 11 publications

(8 citation statements)

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“…19 Subcutaneous blinatumomab is delivered in a small-volume injection (0.3-1.2 mL per dose), is easy to prepare and administer, and has been tolerated by patients without any local reaction or pain. 10,23 The observed high efficacy with SC blinatumomab as monotherapy supports further exploration in earlier lines of therapy which may spare the need for intensive chemotherapy and/or transplantation. It has been demonstrated that the efficacy of blinatumomab is higher in earlier than in later treatment lines.…”

Section: Discussionmentioning

confidence: 84%

“…Intravenous blinatumomab is beneficial for patients with R/R B‐ALL, 2,7,8,16,22 but early data from SC blinatumomab suggest improved efficacy with a more convenient delivery profile. Subcutaneous blinatumomab is delivered in a small‐volume injection (0.3–1.2 mL per dose), is easy to prepare and administer, and has been tolerated by patients without any local reaction or pain 10,23 . The observed high efficacy with SC blinatumomab as monotherapy supports further exploration in earlier lines of therapy which may spare the need for intensive chemotherapy and/or transplantation.…”

Section: Discussionmentioning

confidence: 96%

“…13 Both expansion dosing regimens resulted in observed exposures (mean C avg,ss ) from QD and TIW doses that generally exceeded the exposures (mean C ss ) of the cIV dose (28 μg/day). 10,15 This favorable SC PK profile and higher first week exposures than in cIV may have contributed to the high efficacy with faster and deeper responses compared with the cIV regimen.…”

Section: Discussionmentioning

confidence: 99%

“…Prior CD19‐directed immunotherapy, such as blinatumomab or CAR T‐cell therapy, received more than 4 weeks before enrollment was allowed. The dose escalation and dose‐expansion phases of this trial have been completed 9,10 . Here, we report the results of the dose‐expansion phase.…”

Section: Methodsmentioning

confidence: 99%

“…The dose escalation and dose-expansion phases of this trial have been completed. 9,10 Here, we report the results of the dose-expansion phase.…”

Section: Trial Design and Patientsmentioning

confidence: 99%

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Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia

Jabbour,

Zugmaier,

Agrawal

et al. 2024

American J Hematol

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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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Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 96%