Jun 2025
This report focuses on the timing of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in 1579 patients treated with Breyanzi across various clinical trials and clinical practice. Data was collected from pivotal trials and the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry.
Results from Clinical Trials: Among 702 patients, 46% experienced no CRS, while 54% had CRS of any grade. Most CRS events (98%) occurred within 2 weeks post-infusion, with a median time to resolution of 5 days. For ICANS, 69% had no events, and 31% had ICANS of any grade. Most ICANS events (88%) occurred within 2 weeks post-infusion, with a median time to resolution of 7 days.1
Results from CIBMTR Registry: Among 877 patients, 51% experienced no CRS, while 49% had CRS of any grade. Most CRS events (97%) occurred within 2 weeks post-infusion, with a median time to resolution of 4 days. For ICANS, 73% had no events, and 27% had ICANS of any grade. Most ICANS events (95%) occurred within 2 weeks post-infusion, with a median time to resolution of 5.5 days.1
Conclusion: Data from the Breyanzi clinical trials and the CIBMTR Registry demonstrated that most CRS/ ICANS events occurred ≤2 weeks after infusion and were not severe. For the few patients who experienced onset of CRS/ICANS after Day 15, most events were low grade.1