Subcutaneous blinatumomab

New data presented at the 2026 annual meeting of the European Hematology Association (EHA)by Prof Dr Elias Jabbour (MD Anderson Cancer Center, Houston, TX, USA) highlight the potential of a new subcutaneous formulation of blinatumomab in patients with relapsed or refractory, Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL). Blinatumomab is an established treatment in ALL but requires a continuous intravenous infusion. The development of a subcutaneous formulation wants to provide a more convenient mode of administration and enables the exploration of higher dose levels than those used with the intravenous formulation.

The presented study investigated different dosing schedules, with expansion cohorts evaluating subcutaneous blinatumomab administered either at 250 μg daily during the first week followed by 500 μg three times weekly thereafter, or at 500 μg daily during the first week followed by 1,000 μg three times weekly. Based on safety and efficacy findings, the 250/500 μg regimen was selected as the phase 2 dose.

Previous analyses of the overall study population, comprising 88 patients, demonstrated response rates approaching 90%, high rates of measurable residual disease (MRD) negativity, and 12-month survival of approximately 60%. The analysis presented at EHA 2026 focused specifically on patients with Ph-positive ALL. Efficacy was reported to be comparable between Ph-positive and Ph-negative disease, with response rates exceeding 90%, complete remission or complete remission with partial hematologic recovery rates of approximately 80%, and MRD negativity obtained in more than three quarters of patients. Responses appeared durable, and some patients were able to proceed to a subsequent allogeneic stem cell transplantation or CAR T-cell therapy. In this regard, Prof Jabbour underscored that transplantation did not seem to improve outcomes.

The treatment was generally well tolerated. Immune effector cell-associated neurotoxicity syndrome occurred in a quarter of patients, prompting ongoing efforts to optimize dosing strategies and mitigate this toxicity. Overall, these findings support further evaluation of subcutaneous blinatumomab, including in frontline treatment strategies for Ph-positive ALL in combination with tyrosine kinase inhibitors.