Y-mAbs Announces Update on Omburtamab in DSRCT
DSRCT is an aggressive malignancy that typically presents as intraabdominal sarcomatosis in young males. Less than 100 patients are diagnosed each year in the US, and given this incidence, optimal treatment has not yet been defined. Patients with DSRCT have a very poor prognosis with limited five year survival. Even for those patients where Gross Total Resection (“GTR”) is possible, five year Overall Survival (“OS”) appears to be approximately 20%. Based on observations from MSK, Whole Abdominalpelvic Intensity-Modulated RadioTherapy (“WA-IMRT”) may be advisable for all patients whose tumor can be resected.
Data reported by Dr. Modak was based on evaluation of 33 GTR patients treated at MSK from 2009 to 2017. A total of 24 patients from a Phase I study at MSK received WA-IMRT in combination with omburtamab Interperitoneal Radio Immunotherapy (“IP-RIT”) and nine patients received WA-IMRT without omburtamab IP-RIT. The study showed a median OS of 41 months for the DSRCT patients who did not receive omburtamab IP-RIT and 59 months for those receiving omburtamab IP-RIT. The data presented at CTOS indicates that adding IP-RIT with iodinated omburtamab to the standard WA-IMRT treatment appears to be well tolerated. Furthermore, adding omburtamab IP-RIT to GTR improved the five year Kapplan Meier estimated OS from a historical rate of approximately 20% to approximately 40%. While this approach may not help patients who do not achieve GTR of DSRCT, we believe that it may help patients with microscopic disease and help prevent relapse. Lack of evaluable disease means that survival is the only relevant endpoint for these patients.
“We are excited to announce this update for omburtamab in DSRCT, and have recently started a Phase II trial at MSK. DSRCT represent a clear unmet medical need. We plan to advance omburtamab for the benefit of these patients. It is very encouraging to continue to witness omburtamab produce significant data in additional difficult indications, providing further evidence of omburtamab’s potential across B7-H3 positive solid tumors,” said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.
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.
About Memorial Sloan Kettering
Researchers at Memorial Sloan Kettering (“MSK”) developed the therapeutic product referenced in this statement, which is 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.
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Source: Y-mAbs Therapeutics, Inc