Y-mAbs’ naxitamab shows positive effect in neuroblastoma study

Updated results from a Phase 1/2 clinical trial evaluating Y-mAbs Therapeutics’ (YMAB) naxitamab, combined with a granulocyte-macrophage colony stimulating factor (GM-CSF), in pediatric patients with relapsed/refractory high-risk neuroblastoma showed a treatment benefit. The data were presented at the International Society of Pediatric Oncology in Lyon, France.

Based on results from 28 participants who failed to respond to intensive induction therapy, the overall response rate (ORR) was 78% (n=22/28). The rate of progression-free survival (PFS) at year 2 was 50%.

In a subset of 30 evaluable patients with relapsed neuroblastoma resistant to salvage therapy, the rate of PFS at year 2 was 36% with an ORR of 37%.

Naxitamab is a humanized monoclonal antibody called 3F8 that targets a cancer cell surface protein called GD2.

The company plans to initiate a rolling marketing application in the U.S. next month.

https://seekingalpha.com/news/3509713-y-mabs-naxitamab-shows-positive-effect-neuroblastoma-study