Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GM-CSF
GM-CSF+ Naxitamab · 1 trial · 1 indication
Overall objective response rate (ORR) during the Naxitamab treatment period that will be centrally assessed according to the International Neuroblastoma Response Criteria (INRC) modified with 123I-MIBG criteria and following the use of 18F FDG-PET for MIBG non-avid lesions.
| Arm | Type | Description |
|---|---|---|
| GM-CSF + Naxitamab | EXPERIMENTAL | Each investigational cycle is started with 5 days of GM-CSF administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5 totalling 9 mg/kg per cycle. Treatment cycles are repeated every 4 weeks until CR or PR followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. After end of treatment patients will enter a long-term follow up for up to 3 years after end of treatment visit. |
| Name | Type | Description |
|---|---|---|
| GM-CSF + Naxitamab | BIOLOGICAL | Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Humanized IgG1 monoclonal GD2 antibody |
Inclusion Criteria: * Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria * High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial res...
GM-CSF+ Naxitamab is used for the treatment of neuroblastoma, specifically in high-risk patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow. It is an investigational combination therapy being studied in a Phase 2 clinical trial.
The drug is a monoclonal antibody-based therapy. Naxitamab is a monoclonal antibody that targets the GD2 antigen, which is expressed on neuroblastoma cells. GM-CSF is included to stimulate the immune system. The combination is designed to enhance the immune response against the cancer.
GM-CSF+ Naxitamab is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol YMAB on the NASDAQ exchange.
GM-CSF+ Naxitamab is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities such as the FDA. The ongoing Phase 2 trial is actively recruiting participants.
GM-CSF+ Naxitamab is being studied in a single Phase 2 clinical trial with the identifier NCT03363373. The trial is titled 'Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow' and is enrolling 122 patients across multiple countries.
GM-CSF+ Naxitamab is a combination therapy that includes GM-CSF (granulocyte-macrophage colony-stimulating factor) and naxitamab. While GM-CSF is a component, the drug as a whole is distinct from GM-CSF alone. The combination is being studied specifically for neuroblastoma.