Clinical Trials

Date: 2017-06-04

Type of information: Presentation of results at a congress

phase:

Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago

Company: Memorial Sloan Kettering Cancer Center (USA - NY) Y-mAbs Therapeutics (USA - NY)

Product: burtomab (131-I-8H9), now omburtamab

Action mechanism:

monoclonal antibody/radiopharmaceutical product. 131-I-8H9 monoclonal antibody is a radioimmunoconjugate consisting of the iodine 131-radiolabeled murine IgG1 monoclonal antibody 8H9 directed against the surface immunomodulatory glycoprotein 4Ig-B7-H3 with potential radioimaging and radioimmunotherapeutic uses. Iodine I 131 monoclonal antibody 8H9 binds to 4Ig-B7-H3 (human B7-H3 with 4 Ig-like domains) and may be used to radioimage and/or destroy tumor cells that express tenascin. In vitro, it has been shown that monoclonal antibody-mediated masking of 4Ig-B7-H3 on neuroblastoma cells resulted in the enhancement of natural killer (NK)-mediated lysis of target cells.
Burtomab has been created by Memorial Sloan Kettering Cancer Center and licensed to Y-mAbs Therapeutics. MSK’s Nai-Kong Cheung, MD, PhD, created and tested this antibody.

Disease: refractory leptomeningeal metastasis from neuroblastoma

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• On June 4, 2017, Y-mAbs Therapeutics announced top line results from a pivotal study of 131I-burtomab in refractory leptomeningeal metastasis from neuroblastoma. Results showed a 58 months average survival for the patients treated with 131I-burtomab in the study, compared to an average of 4.7 month and no long term survival or cure, for a contemporary cohort in the Central German Childhood Cancer Registry. After more than a decade of follow-up, data shows more than 40% overall long term survival indicating that the treated children have been cured.
At ASCO, Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center presented the overall survival data from 80 pediatric patients with CNS and leptomeningeal metastasis from neuroblastoma treated at MSK with 131I-burtomab, and Prof. Dr. med. Frank Berthold from the University of Cologne presented comparable historical data from the Central German Childhood Cancer Registry, thereby demonstrating that the use of 131Iburtomab led to a multi-fold increase of the average survival in this patient population, where no other established therapy exists.