Real-world data on bispecific antibodies (BsAbs) administration in community oncology settings.

Abstract

e13532 Background: BsAbs represent a transformative advancement in oncology, with 10 FDA-approved agents as of early 2025. Despite their potential, widespread adoption of BsAbs in community oncology settings has been limited due to risks of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infection, and logistical challenges. Consequently, real-world data on BsAb utilization outside academic centers remain sparse, with no significant publications to date. The American Oncology Network (AON), a large community oncology practice network, has implemented protocols to address these challenges. Starting in late 2022, AON developed standard operating procedures and conducted extensive educational outreach through pharmacy staff and physician leadership. Additionally, staff have engaged with partner hospitals to facilitate inpatient dosing and toxicity management. As of 1/1/2025, over 1100 doses of BsAbs have been administered in AON clinics, representing one of the largest real-world applications of BsAbs outside academic institutions. Methods: Using the Meaningful Insights Biotech Analysis (MiBA) platform, an AON-associated technology partner, and manual data extraction, we analyzed BsAb utilization and outcomes via our EMR database. Eligible patients received BsAb therapy between November 1, 2022, and November 1, 2024. Data collection included demographics, disease characteristics, doses, and other factors listed below. Results: Over 1100 doses of BsAbs were administered across AON clinics during the study period. Patient median age was 70, ECOG performance status 1. 81% of patients were White, and 16% African American. Patients with B-cell lymphoma, myeloma, and SCLC had received a median of 4, 2, and 4 prior lines of therapy, respectively. 16.39% of patients experienced any-grade CRS, 11.48% experienced ICANS. Only 1 patient required tocilizumab. For teclistimab, median PFS has not been reached at 300 days. Values to date are consistent with outcomes reported in clinical trials, suggesting similar efficacy in community settings. Conclusions: This study highlights the feasibility of administering BsAbs in appropriately resourced community oncology settings. AON's comprehensive approach to protocol development, staff training, and clinical oversight across the inpatient and outpatient spectrum has facilitated the safe and effective use of BsAbs at a scale previously limited to academic centers. These data underscore the potential for broader adoption of BsAbs in community practices and support the need for further real-world evidence to optimize their integration into routine oncology care. BsAbs administered and PFS. Drug Patient number Doses given 2023-24 Median PFS (days) Elranatamab 3 37 150 Epcoritamab 10 40 430 Tarlatamab 5 59 126 Mosunetuzumab 8 10 NR Amivantamab 37 375 NR Talquetamab 7 58 76 Teclistimab 14 332 NR NR, Not Reached.