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    DRUG:

    Qarziba (dinutuximab beta)

    i
    Other names: APN 311, ch14.18/CHO
    Company:
    BeOne Medicines, Ligand, Recordati
    Drug class:
    GD2 ganglioside inhibitor
    Related drugs:
    10d
    BEACON2: A Multi-Arm, Platform Trial For Relapsed Neuroblastoma (clinicaltrials.gov)
    P1/2, N=160, Recruiting, University of Birmingham
    New P1/2 trial
    |
    Avastin (bevacizumab) • irinotecan • topotecan • Qarziba (dinutuximab beta)
    16d
    Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    temozolomide • irinotecan • Epidaza (chidamide) • Qarziba (dinutuximab beta)
    21d
    Extended cycles of anti-GD2 antibody dinutuximab beta treatment combined with chemotherapy in patients with relapsed or refractory neuroblastoma: A retrospective study. (PubMed, Oncol Lett)
    In this single-center retrospective study, children with a median age 5.1 years (range, 2.0-11.1 years) with R/R HR-NB who were treated with >5 cycles of dinutuximab beta (10 mg/m2/day for 10-days per 35-day cycle), granulocyte-macrophage colony-stimulating factor (GM-CSF) and isotretinoin, plus chemotherapy, were included. No immune-related deaths occurred. Overall, cycles beyond the standard 5 cycles of dinutuximab beta with chemoimmunotherapy were effective and tolerable in pediatric patients with R/R HR-NB, demonstrating improved response and survival outcomes.
    Retrospective data • Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    Qarziba (dinutuximab beta)
    3ms
    Prolonged overall survival in a child with multimetastatic retinoblastoma treated with anti-GD2 monoclonal antibody dinutuximab beta: a case report. (PubMed, Front Oncol)
    The patient was treated with systemic conventional and high-dose chemotherapy combined with intrathecal Topotecan. This case suggests that anti-GD2 immunotherapy, used as consolidation treatment, may improve the prognosis of patients with advanced retinoblastoma and potentially reduce the toxicity associated with standard therapies. Further clinical investigation is warranted to validate these findings.
    Journal • IO biomarker
    |
    RB1 (RB Transcriptional Corepressor 1)
    |
    topotecan • Qarziba (dinutuximab beta)
    3ms
    ANBL19P1: Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
    P2, N=41, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2025 --> Sep 2027
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    3ms
    Inbraced: Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, University Hospital Southampton NHS Foundation Trust | Trial completion date: Jul 2025 --> Nov 2025
    Trial completion date
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
    3ms
    The role of dinutuximab beta with beta cell function, apoptosis, and proliferation: new approaches to proteomic analysis of insulinoma. (PubMed, Invest New Drugs)
    Several proteins not previously associated, or only indirectly linked, with beta cell function, apoptosis, or proliferation were identified and characterized for the first time in insulinoma. These findings provide new insights and potential targets for the treatment of pancreatic cancer.
    Journal • IO biomarker
    |
    PTEN (Phosphatase and tensin homolog) • BCL2 (B-cell CLL/lymphoma 2) • CASP3 (Caspase 3) • FN1 (Fibronectin 1) • PCNA (Proliferating cell nuclear antigen) • PDX1 (Pancreatic And Duodenal Homeobox 1) • NEUROD1 (Neuronal Differentiation 1) • HSPA8 (Heat Shock Protein Family A (Hsp70) Member 8)
    |
    Qarziba (dinutuximab beta)
    3ms
    NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2025 --> Sep 2026
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
    4ms
    Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
    P3, N=750, Recruiting, Children's Oncology Group | Trial completion date: Sep 2026 --> Sep 2030 | Trial primary completion date: Sep 2026 --> Sep 2030
    Trial completion date • Trial primary completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    cisplatin • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • dexrazoxane
    4ms
    Chemo-Immunotherapy Rescue for High-Risk Neuroblastoma Patients With Progressive Disease Before High-Dose Chemotherapy: Real-World Data From the SACHA-France Study. (PubMed, Pediatr Blood Cancer)
    Chemo-immunotherapy can benefit HR-NBL patients with PD before HDC, including those with progression during/at the end of the induction chemotherapy and NMYC amplification. These findings support its early inclusion in HR-NBL trials.
    Journal • Real-world evidence
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    temozolomide • cyclophosphamide • irinotecan • topotecan • Qarziba (dinutuximab beta)
    4ms
    Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
    P3, N=750, Recruiting, Children's Oncology Group | Active, not recruiting --> Recruiting
    Enrollment open
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    cisplatin • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • dexrazoxane
    4ms
    Dinutuximab Beta Versus Naxitamab in the Treatment of Relapsed/Refractory Neuroblastoma in Patients with Stable Disease, Minor Response or Partial Response and Disease in Bone or Bone Marrow: Systematic Review and Matching-Adjusted Indirect Comparison. (PubMed, Cancers (Basel))
    Sensitivity analyses and unadjusted comparisons supported the results. In the indirect comparison, dinutuximab beta significantly extended PFS and increased ORR compared to naxitamab.
    Journal
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2)
    |
    Qarziba (dinutuximab beta) • Danyelza (naxitamab-gqgk)