Drug updated on 10/31/2024
| Dosage Form | Injection (intravenous; 17.5 mg/5 mL) |
| Drug Class | BD2-binding monoclonal antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- DFMO (Eflornithine) Post-Immunotherapy for High-Risk Neuroblastoma (HRNB): DFMO improved event-free survival (EFS) and overall survival (OS) in HRNB patients post-immunotherapy compared to a control group; EFS (Hazard Ratio (HR), 0.50 [95% CI, 0.29 to 0.84]; P = .008) and OS (HR, 0.38 [95% CI, 0.19 to 0.76]; P = .007).
- Dinutuximab Immunotherapy for HRNB: Patients in the dinutuximab immunotherapy group showed higher 5-year survival outcomes than those in the isotretinoin-only group, with a 5-year EFS of 56.6 ± 4.7% vs. 46.1 ± 5.1% (P = 0.042) and a 5-year OS of 73.2 ± 4.2% vs. 56.6 ± 5.1% (P = 0.045).
- Effectiveness Summary: Both DFMO and dinutuximab demonstrated significant improvements in EFS and OS for HRNB patients, with DFMO showing HRs of 0.50 for EFS and 0.38 for OS, and dinutuximab showing a 10.5% higher 5-year EFS and 16.6% higher 5-year OS compared to isotretinoin-only treatment.
- There is no safety information available in the reviewed studies for DFMO. For dinutuximab, 13 out of 122 patients developed human anti-chimeric antibodies (HACA), but these did not correlate with event-free or overall survival or with clinically significant toxicity; FC gamma receptor 2A and 3A genotypes similarly showed no correlation with survival or significant toxicity.
- There is no population types or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Unituxin (dinutuximab) Prescribing Information. | 2020 | United Therapeutics Corporation, Silver Spring, MD |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons | 2024 | Journal of Clinical Oncology |
| Long-Term Follow-up of a Phase III Study of ch14.18 (Dinutuximab) + Cytokine Immunotherapy in Children with High-Risk Neuroblastoma: COG Study ANBL0032 | 2021 | Clinical Cancer Research |