Y-mAbs Announces Publication of Phase 2 Interim Results in Nature Communications

Core Insights - Y-mAbs Therapeutics, Inc. announced interim data from a Phase 2 clinical trial of naxitamab combined with GM-CSF for treating relapsed/refractory high-risk neuroblastoma, published in Nature Communications [1][2] Group 1: Clinical Trial Results - The Phase 2 trial (Trial 201, NCT03363373) involved patients with relapsed/refractory high-risk neuroblastoma, showing an overall response rate (ORR) of 50% (95% CI: 36-64%, N = 52) [2][3] - Complete response (CR) and partial response (PR) rates were 38% and 12%, respectively, with 58% of responders having refractory disease and 42% having relapsed disease [3] - Among patients with evaluable bone disease, the bone compartment response was 58% (29/50), with CR at 40% and PR at 18% [3] - The bone marrow compartment response was 74% (17/23; CR, 74%) [3] - One-year overall survival was 93% (95% CI: 80-98%) and progression-free survival was 35% (95% CI: 16-54%) [3] Group 2: Safety Profile - In the safety population (N=74), treatment-related adverse events were primarily infusion-related (90%), with hypotension (58% Grade 3 and 3 Grade 4 AEs) and bronchospasm (18% Grade 3) being the most common [4] - Grade 3 pain, a known effect of anti-GD2 immunotherapy, was frequently observed but generally resolved within 15 minutes post-infusion [4] Group 3: Company Overview - Y-mAbs is focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [6] - The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma after prior therapy [6]