Y-mAbs Announces Publication in Cancers
Naxitamab-based chemo-immunotherapy significantly improves long-term outcomes when administered early during the course of treatment
NEW YORK, Oct. 16, 2023 (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 the publication of naxitamab-based chemoimmunotherapy in patients with chemoresistant high-risk neuroblastoma (“HR-NB”) in the journal Cancers.
“The publication in Cancers further validates the utilization of naxitamab early during the course of treatment for patients with high-risk neuroblastoma,” said Thomas Gad, Founder, President and Interim Chief Executive Officer. “In this study, early administration of naxitamab-based chemo-immunotherapy was shown to significantly improve long-term outcomes, addressing an important unmet need in the current treatment paradigm for this critical patient group.”
Approximately 50% of HR-NB patients are unable to achieve a complete response (“CR”) or very good partial response (“VGPR”) at the end of induction (“EOI”) and have poor long term outcomes. This analysis investigated the combination of humanized anti-GD2 mAb naxitamab (“Hu3F8”), irinotecan (“I”), temozolomide (“T”), and sargramostim (“GM-CSF”)—HITS—in patients with HR-NB who did not achieve a CR/VGPR to induction. Cycles were administered 3-5 weeks apart and the primary endpoint was overall response rate (CR + partial response (“PR”)).
Patients who received HITS immediately after induction had higher response rates (47% vs. 18%) and superior estimated 3-year overall survival (85% vs. 29%) compared with those who received the same combination regimen later in the course of treatment. Safety results showed that the findings were consistent with previous studies for naxitamab and HITS. The HITS combination did not appear to exacerbate the rate nor the intensity of infusion-related toxicities of naxitamab when observed as a stand-alone treatment.
“These results suggest that the combination of naxitamab and chemotherapy, when promptly initiated in patients with an incomplete EOI response, can overcome chemoresistance,” said Dr. Jaume Mora, the study’s principal investigator at Sant Joan de Déu Barcelona Children’s Hospital. “By contrast, a profound resistance may develop in patients administered additional treatment before receiving HITS, underscoring the need to initiate the naxitamab-based chemo-immunotherapy as early as possible.”
For more information on this critical development in the treatment paradigm for patients with high-risk neuroblastoma, the online publication is available .
Researchers at Memorial Sloan Kettering Cancer Center (MSK) developed DANYELZA® (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests in the compound and Y-mAbs.
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 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 cancer products. In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.
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DANYELZA®, OMBLASTYS® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.
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