Y-mAbs Announces Frontline Data for DANYELZA® (naxitamab-gqgk) in High-Risk Neuroblastoma
Y-mAbs Therapeutics, focused on innovative cancer treatments, announced the presentation of three-year follow-up data for DANYELZA and GM-CSF in high-risk neuroblastoma patients at the ASCO Virtual Annual Meeting on June 4, 2021. The study included 73 patients, showing a three-year event-free survival of 74% for first complete remission and 19% for later remissions. Overall survival rates were 92% and 66%, respectively. The positive data suggests DANYELZA's potential to differentiate itself from existing therapies if approved.
- Three-year event-free survival rates of 74% for first complete remission patients.
- Overall survival rates of 92% for first complete remission patients.
- DANYELZA's potential to significantly differentiate from existing therapies if approved.
- None.
NEW YORK, June 04, 2021 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Dr. Jaume Mora, M.D., Ph.D. from SJD Barcelona Children's Hospital will present frontline data for DANYELZA and GM-CSF for consolidation of high-risk neuroblastoma (“HR-NB”) patients in complete remission at the American Society of Clinical Oncology (“ASCO”) Virtual Annual Meeting on June 4, 2021
Patients received five cycles of DANYELZA and GM-CSF in a compassionate use setting for consolidation of HR-NB in first or subsequent complete remission (“CR”). DANYELZA was administered in an outpatient setting on days 1, 3 and 5 at 9.0 mg/kg/cycle in combination with GM-CSF, and treatment cycles were repeated every four weeks. From June 2017 to November 2020, a total of 73 patients were treated: 55 patients (
“We are very pleased to report such encouraging three-year follow-up data in frontline high-risk neuroblastoma for DANYELZA in patients that are in full remission after the induction regiment,” stated Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer, continued, “We are excited to see the three-year data holding up so well for the frontline patients and, if approved, we believe this could potentially significantly differentiate DANYELZA from other existing therapies.”
Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.
About DANYELZA® (naxitamab-gqgk)
DANYELZA® (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA® includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
About Y-mAbs
Y-mAbs is a commercial-stage 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 one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
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“DANYELZA” and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
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