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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:
    6d
    Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children (clinicaltrials.gov)
    P2, N=27, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    temozolomide • irinotecan • Epidaza (chidamide) • Qarziba (dinutuximab beta)
    8d
    NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
    P2, N=42, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Sep 2026 --> Mar 2026
    Trial completion • Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
    29d
    BEACON: Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children (clinicaltrials.gov)
    P2, N=225, Completed, University of Birmingham | Active, not recruiting --> Completed
    Trial completion
    |
    Avastin (bevacizumab) • temozolomide • cyclophosphamide • irinotecan • topotecan • Qarziba (dinutuximab beta)
    1m
    BEACON: Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children (clinicaltrials.gov)
    P2, N=225, Completed, University of Birmingham | Active, not recruiting --> Completed | Completed --> Active, not recruiting
    Trial completion • Enrollment closed
    |
    Avastin (bevacizumab) • temozolomide • cyclophosphamide • irinotecan • topotecan • Qarziba (dinutuximab beta)
    1m
    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: Nov 2025 --> Sep 2026
    Trial completion date
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
    2ms
    Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (clinicaltrials.gov)
    P1/2, N=76, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: May 2026 --> Jul 2026
    Trial initiation date
    |
    cyclophosphamide • topotecan • Qarziba (dinutuximab beta) • iberdomide (CC-220) • Unituxin (dinutuximab) • Leukine (sargramostim)
    2ms
    Comprehensive molecular analyses for diagnosis and treatment guidance in an adult neuroblastoma patient. (PubMed, Oncologist)
    Comprehensive molecular analysis and MTB discussion revealed several potential treatment targets, leading to subsequent treatment including dinutuximab beta, nivolumab, cabozantinib, I-131-mIBG radionuclide therapy and alpelisib, unfortunately, all followed by disease progression. This case demonstrates the potential of comprehensive molecular analysis including methylation profiling for diagnosis and treatment guidance in rare tumors. Additional research is urgently required to improve outcomes in elderly patients with neuroblastoma.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    NTRK (Neurotrophic receptor tyrosine kinase)
    |
    NTRK fusion
    |
    Opdivo (nivolumab) • Piqray (alpelisib) • Cabometyx (cabozantinib tablet) • Qarziba (dinutuximab beta)
    2ms
    End-of-Induction Response and Tolerability of High-Risk Neuroblastoma Treated with Chemoimmunotherapy-Modified N7 Regimen with Dinutuximab Beta. (PubMed, Cancers (Basel))
    The incorporation of dinutuximab beta into a modified N7 induction regimen demonstrates a satisfactory EOI response rate and a manageable safety profile in children with HR-NB. These preliminary results support the feasibility of this chemoimmunotherapy approach and warrant further investigation in larger cohorts to confirm its efficacy in long-term survival outcomes.
    Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    Qarziba (dinutuximab beta)
    3ms
    NANT: Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (clinicaltrials.gov)
    P1, N=27, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date
    |
    lenalidomide • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    3ms
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    3ms
    Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (clinicaltrials.gov)
    P1/2, N=76, Not yet recruiting, National Cancer Institute (NCI)
    New P1/2 trial
    |
    cyclophosphamide • topotecan • Qarziba (dinutuximab beta) • iberdomide (CC-220) • Unituxin (dinutuximab) • Leukine (sargramostim)
    4ms
    Efficacy and safety of dinutuximab beta combined with GM-CSF and isotretinoin ± chemotherapy as first-line maintenance treatment for pediatric high-risk neuroblastoma in China. (PubMed, Front Oncol)
    Real-world evidence on dinutuximab beta for high-risk neuroblastoma (NB) in the Chinese pediatric patients remains limited. Patients treated with prior ASCT or combined with chemotherapy showed trends toward improved response rates and survival outcomes, although optimal treatment regimens required further investigation. AEs are generally manageable, and the use of standardized pain assessment combined with multimodal analgesia has enabled a substantial reduction in morphine exposure.
    Journal
    |
    CSF2 (Colony stimulating factor 2)
    |
    Qarziba (dinutuximab beta)