Balancing Monitoring and Access: Optimal Duration of Monitoring for CD19 and BCMA CART Recipients for Lymphoma and Myeloma

Background: Due to the risks of cytokine release syndrome (CRS) and immune effector cell-associated neurologic syndromes (ICANS), a four-week monitoring period near the authorized treating center (ATC) is a requirement for all currently approved chimeric antigen receptor T cell (CART) therapies, as part of the required Risk Evaluation and Mitigation Strategy (REMS) programs. The purpose of the REMS program is to facilitate prompt administration of tocilizumab within 2 hours in the event of life-threatening adverse events . Most ATCs require patients to stay within a 30-60-minute radius of the ATC and require a dedicated caregiver. While monitoring is essential for safety, the optimal duration of monitoring post-CART has not been studied. It is an area of need as there is a known financial burden of relocation, which may increase gaps in access to care, especially for underserved populations. We evaluated real-world safety outcomes of patients receiving CD19 and BCMA CART for non-Hodgkin lymphoma (NHL) and relapsed refractory multiple myeloma (RRMM). Methods: Patients (pts) with NHL and RRMM who received commercial CD19-directed (axi-cel, tisa-cel, liso-cel, brexu-cel) and BCMA-directed CART (ide-cel, cilta-cel) respectively, from 1/2017 to 1/2023, at the University of Kansas Health System and Medical University of South Carolina were included. Based on each patient's 5-digit zip code, travel distance to the ATC, median household income, and rural or urban residence were estimated. Patients were divided into two groups: those who had either first or recurrent CRS or ICANS occurring at Day 7 or later (Events≥ D7) and the group with no CRS/ICANS ≥ Day 7 (No Events ≥ D7). Chi-square test and proportion tests were calculated. Results: 185 patients (pts) including 127 NHL pts (59% axi-cel, 19% tisa-cel, 13% liso-cel, 8% brexu-cel) and 58 RRMM pts (75% ide-cel and 25% cilta-cel) were included. Most patients (65%) lived beyond 30 minutes of the ATC, and only 23.2% were from rural neighborhoods. (Table 1) 150 pts were in the “No Events ≥ D7” while 35 pts were in the Events≥ D7 group. There were no differences in baseline characteristics of these groups (Table 1). 151 pts (81.6%) and 70 (39%) pts developed new-onset CRS and ICANS respectively on D0-28. Median time to onset for CRS vs ICANS: 2 (IQR 25-75%:1-4) vs 5 (IQR 25-75%:3-8). Median time to CRS vs ICANS resolution relative to infusion was 6 days (IQR 25-75%: 3-7) vs 11 days (IQR 25-75%: 8-15). 137 (91%) had on