Blinatumomab administration in the outpatient setting: Safety and health care utilization
Yannis K. Valtis, Benjamin F. Frost, David Nemirovsky, Andriy Derkach, Kuo‐Kai Chin, Meira Yisraeli Salman, Leora Boussi, Natalia Tijaro Ovalle, Emilie Baxter, Ann Mercurio, Eytan M. Stein, Mark B. Geyer, Deborah Schrag, Amar H. Kelkar, Daniel J. DeAngelo, Marlise R. Luskin, Jae H. Park, Evan C. ChenABSTRACT
Background
Blinatumomab, a bispecific CD19 × CD3 antibody is effective for the treatment of B‐cell acute lymphoblastic leukemia (ALL). Because of its immune toxicities, namely cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), the US Food and Drug Administration (FDA) recommends preemptive hospitalization for the initiation of cycle 1 (C1) and cycle 2 (C2). The necessity of this approach is unclear.
Methods
The authors conducted a retrospective cohort study among all patients treated with blinatumomab between 2012 and 2025 at two academic cancer centers: Memorial Sloan Kettering Cancer Center (MSK) and Dana‐Farber Cancer Institute (DFCI).
Results
For C1, only nine of 308 (3%) patients initiated outpatient (OP) treatment. A total of 184 of 308 (60%) initiated C2: At DFCI, 10 of 83 (12%) initiated C2 OP and at MSK, and 74 of 101 (88%) initiated C2 OP. Demographic and clinical characteristics were similar between patients initiating C2 inpatient versus OP. No patients who initiated C2 (0 of 184) had Gr3+ CRS (across all cycles) and only two (1%) had Gr3+ ICANS; both were inpatient for C2. Of 84 patients treated without preemptive hospitalization for C2, 16 of 84 (19%) required hospitalization at some point during the cycle, largely for infections (50%).
Conclusions
OP administration of C2 of blinatumomab can be administered safely with no unexpected, severe, or life‐threatening toxicities. The ability to safely manage treatment without preemptive hospitalization may support the patient experience and limit costs of care.