Y-mAbs announces publication of Phase 2 interim results on naxitamab

Y-mAbs Therapeutics (YMAB) announced the publication of interim data from a Phase 2 clinical trial evaluating naxitamab with granulocyte-macrophage colony-stimulating factor, GM-CSF, in patients with relapsed/refractory high-risk neuroblastoma in the journal Nature Communications. The primary endpoint in the prespecified interim analysis was overall response. Overall response rate was 50%, and CR and PR were observed in 38% and 12%, respectively. Among 26 responders in the efficacy population, 58% had refractory disease, and 42% had relapsed disease. With the 95% CI lower limit for ORR exceeding 20%, the primary endpoint of overall response was met. Patients with evaluable bone disease had a 58% bone compartment response. Bone marrow compartment response was 74%. One-year overall survival and progression-free survival were 93% and 35%, respectively. Notably, of the 13 patients who had been previously treated with anti-GD2 monoclonal antibodies before enrolling in this study, 4 responded to naxitamab.