Danyelza (naxitamab-gqgk) / Y-mAbs Therap, Takeda, SciClone, Nobelpharma, INPHARMUS - LARVOL DELTA

The Psychological Experience of Caregivers of Children With Neuroblastoma Undergoing Naxitamab Treatment: A Qualitative Study in China. (PubMed, Child Care Health Dev) - "Caregivers of children undergoing naxitamab treatment for NB encounter diverse psychological challenges throughout different stages. It is crucial for clinical medical professionals to provide tailored psychological support to both children and their families during various stages of treatment."

Journal • CNS Disorders • Depression • Mood Disorders • Neuroblastoma • Oncology • Psychiatry • Solid Tumor

Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma (clinicaltrials.gov) - P1 | N=85 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jul 2025 | Trial primary completion date: Jan 2026 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=93 | Recruiting | Sponsor: Giselle Sholler | Trial completion date: Sep 2033 ➔ Sep 2035 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Real-life Use of IV Naxitamab for Children With Relapsed/Refractory Neuroblastoma. (PubMed, J Pediatr Hematol Oncol) - "Between November 2021 and July 2023, 102 Naxitamab infusions were administered at Shaare Zedek Hospital with ketamine as the only analgesic drug during Naxitamab infusion. Thus, its use is feasible in multiple clinical settings. Significant infusion-related AEs after the completion of the 3rd treatment cycle are rare."

Journal • Neuroblastoma • Oncology • Pain • Solid Tumor

Rapid COJEC without myeloablative therapy for high-risk neuroblastoma. (PubMed, Int J Cancer) - "Group 1 patients had resection of primary tumors and received 1-2 cycles of HR-NB regimens (cyclophosphamide-topotecan ± vincristine), local radiotherapy, and naxitamab + GM-CSF; 9 also received anti-NB vaccine...Group 2 patients received second-line therapy post-COJEC, including high-dose cyclophosphamide + topotecan ± vincristine or cyclophosphamide + doxorubicin + vincristine. Treatment after all chemotherapy included naxitamab + GM-CSF ± irinotecan-temozolomide...Six developed PD (four are again in complete remission and two died of NB). Avoiding MAT after rapid COJEC does not appear to adversely affect outcome compared to rapid COJEC + MAT."

Journal • Endocrine Cancer • Hematological Malignancies • Myelodysplastic Syndrome • Neuroblastoma • Oncology • Solid Tumor • Thyroid Gland Carcinoma • CSF2

Navigating Naxitamab: Equipping Interdisciplinary Teams for Success (APHON 2025) - No abstract available

High-risk neuroblastoma in Mexico: from multimodal treatment to immunotherapy. Regarding the first case treated with naxitamab. (PubMed, Front Oncol) - "Despite their high costs, the demonstrated benefits should outweigh the disadvantages, justifying efforts to make them accessible to all patient populations. Future studies in LMICs including Mexico and Latin America, must focus on optimizing dosing strategies to minimize adverse effects and improve both survival outcomes and the quality of life for patients receiving immunotherapy."

Journal • Review • CNS Disorders • Critical care • Dermatology • Hypotension • Immunology • Neuroblastoma • Oncology • Ophthalmology • Pediatrics • Pruritus • Solid Tumor • Urticaria • Ventriculomegaly

A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma (clinicaltrials.gov) - P2 | N=59 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Study of Chemoimmunotherapy for High-Risk Neuroblastoma (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor • MYCN

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Steven DuBois, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Neuroblastoma • Oncology • Solid Tumor

111In/225Ac-Naxitamab: Theranostic anti-GD2 antibody in the management of Osteosarcoma - in-vitro evaluation (SNMMI 2025) - "The radiolabeling yield of 111In-Naxitamab was 99%; therefore, no further purification was needed. The specific activity was 27.75 MBq/nmol. The radiolabeling yield for 225Ac-Naxitamab was 30-40%, and after purification with a PD-10 column, radiochemical purity was 99%."

Preclinical • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

111In/225Ac-Naxitamab: Theranostic anti-GD2 antibody in the management of Osteosarcoma - in-vitro evaluation (SNMMI 2025) - "The radiolabeling yield of 111In-Naxitamab was 99%; therefore, no further purification was needed. The specific activity was 27.75 MBq/nmol. The radiolabeling yield for 225Ac-Naxitamab was 30-40%, and after purification with a PD-10 column, radiochemical purity was 99%."

Preclinical • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Pulmonary Toxicity Associated With Concurrent Lorlatinib and Anti-GD2 Monoclonal Antibody Therapy in Patients With Neuroblastoma. (PubMed, Pediatr Blood Cancer) - "Concurrent use of lorlatinib with anti-GD2 mAbs may be associated with severe pulmonary toxicities. Temporarily withholding lorlatinib during immunotherapy appeared to mitigate this risk."

Adverse events • Journal • Cough • Neuroblastoma • Oncology • Respiratory Diseases • Solid Tumor • ALK

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Steven DuBois, MD

New P1 trial • Neuroblastoma • Oncology • Solid Tumor

A novel therapeutic strategy for osteosarcoma using anti-GD2 ADC and EZH2 inhibitor. (PubMed, Biomark Res) - "We constructed an ADC by conjugating naxitamab to mertansine (DM1) via an SMCC linker. Tazemetostat upregulates GD2 expression, enhancing the ADC's efficacy. This dual-approach strategy demonstrates the potential of integrating epigenetic modulation with targeted drug delivery, offering a promising path for improving outcomes in hard-to-treat cancers."

Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sun Yat-sen University | N=30 ➔ 120 | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC) (clinicaltrials.gov) - P1/2 | N=31 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

The combination of naxitamab with or without sintilimab (anti-PD-1) for the treatment of refractory/progressive neuroblastoma: A prospective, non-randomized, multicenter trial. (ASCO 2025) - P2 | "Refractory or progressive NB is expected to benefit from the treatment regimen involving naxitamab in combination with sintilimab, though larger sample sizes are needed for validation."

Clinical • Endocrine Disorders • Neuroblastoma • Oncology • Solid Tumor • CSF2 • MYCN

Irinotecan, temozolomide and naxitamab plus GM-CSF (HITS) and naxitamab plus GM-CSF and ifosfamide, carboplatin, etoposide (NICE) for patients with relapsed or refractory high-risk neuroblastoma: A single center, open-label phase 2 clinical trial. (ASCO 2025) - "11 NAX and 4 dinutuximab beta). Our clinical trial results suggest different chemotherapy combinations with naxitamab have the potential to rescue patients with R/R HR-NB. No unexpected toxicities were found when combining NAX with different chemotherapeutic agents."

Clinical • P2 data • Dermatology • Hematological Disorders • Immunology • Neuroblastoma • Oncology • Pain • Solid Tumor • Thrombocytopenia • Urticaria • CSF2

Dinutuximab BetaVersus Naxitamab in the Treatment of Relapsed/Refractory Neuroblastoma - Matching-Adjusted Indirect Treatment Comparison and Economic Evaluation in Mexico (ISPOR 2025) - "Compared to naxitamab, dinutuximab beta improves survival in patients with relapsed/refractory neuroblastoma and is cost-saving in the health care system in Mexico."

HEOR • Neuroblastoma • Oncology • Solid Tumor • MYCN

Dinutuximab Beta Versus Naxitamab in the Treatment of Relapsed/ Refractory Neuroblastoma – Matching-Adjusted Indirect Treatment Comparison and Economic Evaluation in the Private Health Insurance System in Brazil (ISPOR 2025) - "Compared to naxitamab, dinutuximab beta improves survival in patients with relapsed/refractory neuroblastoma and is cost-saving in private health insurance system in Brazil."

HEOR • Reimbursement • US reimbursement • Neuroblastoma • Oncology • Solid Tumor • MYCN

Y-mAbs Reports First Quarter 2025 Financial Results and Recent Corporate Developments (GlobeNewswire) - "Total revenues for the quarter ended March 31, 2025 were $20.9 million, which was a 5% increase over the $19.9 million of total revenues for the quarter ended March 31, 2024, primarily driven by a $6.7 million increase in Ex-U.S. DANYELZA revenue, partially offset by a $5.2 million decrease in U.S. DANYELZA revenue and $0.5 million decrease related to license revenue recognized in the three months ended March 31, 2024....The Company’s Ex-U.S. DANYELZA net product revenues for the quarter ended March 31, 2025 were $7.5 million, representing an increase of $6.7 million from the same period in 2024."

Sales • Neuroblastoma

Safety of Naxitamab+GM-CSF in Combination With Induction Chemotherapy in High-Risk Neuroblastoma (ASPHO 2025) - "No new safety concerns have emerged: The safety profile of naxitamab when combined with induction chemotherapy was found to be manageable and acceptable."

Clinical • Combination therapy • Cardiovascular • Hypertension • Hypotension • Neuroblastoma • Pain • Pulmonary Disease • Solid Tumor • CSF2

Y-mAbs Announces Update to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Neuroblastoma to Include Naxitamab-gqgk (DANYELZA) (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced that naxitamab-gqgk (DANYELZA) is recommended by the National Comprehensive Cancer Network ('NCCN') Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a NCCN Category 2A treatment option for high-risk neuroblastoma."

NCCN guideline • Neuroblastoma

A first-in-human phase 1, multicenter, open-label study of M3554, a novel anti-GD2 antibody-drug conjugate (ADC), in patients with advanced solid tumors (AACR 2025) - P1 | "GD2 is a clinically validated target in pediatric neuroblastoma; however, currently approved anti-GD2 antibody treatments, such as dinutuximab and naxitamab, have been associated with severe adverse events (AEs) of pain, likely due to Fcγ receptor-mediated immune activation via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The study is currently recruiting and aims to enroll 52 patients in the dose escalation phase and 110 patients in the dose expansion phase (STS, n=80; GBM, n=30), across different global sites including, Japan, Belgium, France, and the US. Clinical trial information: NCT06641908."

Clinical • Metastases • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Neuroblastoma • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor