“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”)).
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