161P Assessment of corticosteroid premedication for patients treated with the humanized GD2-binding monoclonal antibody naxitamab

Naxitamab (hu3F8) is a humanized monoclonal antibody intended for use in the outpatient setting and has been approved by the FDA for the treatment of high-risk (HR) relapsed/refractory (R/R) neuroblastoma in the bone and bone marrow. This accelerated approval was based on interim data from 22 patients in the pivotal phase 2 clinical study (Trial 201). During Trial 201, the protocol was amended to require premedication with corticosteroids prior to the first naxitamab infusion (C1D1) to mitigate the risk of hypersensitivity reactions.