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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
1m
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
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RB1 (RB Transcriptional Corepressor 1)
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topotecan • Qarziba (dinutuximab beta)
1m
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
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: Jul 2025 --> Nov 2025
Trial completion date
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PD-L1 expression
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Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
1m
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
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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)
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Qarziba (dinutuximab beta)
2ms
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
2ms
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
2ms
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
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
temozolomide • cyclophosphamide • irinotecan • topotecan • Qarziba (dinutuximab beta)
2ms
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
3ms
Journal
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2)
|
Qarziba (dinutuximab beta) • Danyelza (naxitamab-gqgk)
5ms
FC gamma receptor polymorphism in relapsed/refractory high-risk neuroblastoma patients correlates with outcomes in the SIOPEN dinutuximab beta long-term infusion trial. (PubMed, Clin Cancer Res)
Dinutuximab beta LTI was well tolerated and clinically active in patients with relapsed/refractory high-risk neuroblastoma, with Fc-gamma receptor polymorphisms and natural killer cells identified as prognostic biomarkers.
Journal
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IL2 (Interleukin 2)
|
Qarziba (dinutuximab beta)
5ms
DBPilot: Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma (clinicaltrials.gov)
P1, N=38, Recruiting, Princess Maxima Center for Pediatric Oncology | Not yet recruiting --> Recruiting
Enrollment open
|
Qarziba (dinutuximab beta)
7ms
Autophagy inhibition amplifies anti-tumor immunity effect of dinutuximab beta on neuroblastoma via the VEGFR/AKT/mTOR and ROS/NF-κB pathways. (PubMed, Int Immunopharmacol)
Dinutuximab beta also triggers autophagy in NB cells, and inhibition of the VEGFR pathway with anlotinib amplifies dinutuximab beta-induced autophagy. Furthermore, autophagy inhibition by CQ enhances CXCL9 expression and anti-tumor T cell responses of single anti-GD2 therapy in vitro and in vivo. Collectively, this study suggests autophagy inhibitors may be a promising strategy for enhancing therapeutic efficacy in NB in conjunction with anti-GD2 immunotherapy.
Journal • IO biomarker
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CD8 (cluster of differentiation 8) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
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Focus V (anlotinib) • Qarziba (dinutuximab beta)