Y-mAbs Announces Positive Omburtamab Clinical Data
An updated data readout as of
In addition, 68 patients diagnosed with other CNS cancers, including metastatic tumors had received a total of 201 injections of omburtamab. Injections were routinely administered in an outpatient setting. Rare self-limited adverse events included grade 1 or 2 fever, headache, vomiting; 3 injections were associated with grade 3 toxicities requiring discontinuation of therapy including chemical meningitis and increasing communicating hydrocephalus. Although not a dose limiting toxicity, myelosuppression occurred in patients who had received craniospinal radiation and at dose levels exceeding 60mCi. The primary CNS diagnoses included medulloblastoma (n=27), ependymoma (n=9), and embryonal tumors with multilayered rosettes (n=4), while metastatic tumors included sarcoma (n=9), melanoma (n=5), and other tumors (n=14). As of today, 26 of the 68 patients with these highly lethal diagnoses remain alive.
“We are excited to announce this updated data for omburtamab in CNS/leptomeningeal metastases from high-risk neuroblastoma further confirming the importance of omburtamab in addressing this unmet medical need. Further very interesting proof of concept data for other CNS cancers suggests potential clinical utility for use of omburtamab beyond neuroblastoma. Overall survival data have already been accepted by the
Researchers at MSK developed the therapeutic products referenced in this statement, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the products and in Y-mAbs.
Y-mAbs is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, respectively.
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Source: Y-mAbs Therapeutics, Inc