Pivotal 101 multicenter study of Omblastys in neuroblastoma presented at International Society of Pediatric Oncology Annual Congress
Y-mAbs Therapeutics announced clinical data on the Company’s product candidate Omblastys (131I-omburtamab) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma
In an oral presentation, Dr. Kramer presented interim results for 32 patients enrolled in the Company’s ongoing pivotal 101 multicenter study of omburtamab radiolabeled with Iodine-131.
The results showed a twelve-month overall survival of 73.5%, with a median follow-up of 25 months. Further, the interim results showed an objective response rate of 31.3% in the patients with measurable disease after central review based on Response Assessment in Neuro-Oncology criteria and European Association of Neuro-Oncology /European Society for Medical Oncology criteria, and that a total of 75.0% of the patient with measurable disease achieved disease control.
Serious Adverse Events was found in 40.6% of the patients and were mostly related to myelosuppression. Data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center at the International Society of Pediatric Oncology Annual Congress held September 28 through October 1, 2022, in Barcelona, Spain.
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