Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as XM22
Lipegfilgrastim · 2 trials · 2 indications
Grade 4 neutropenia measured in days
A total of 7 PK samples will be obtained at prespecified periods
| Arm | Type | Description |
|---|---|---|
| lipegfilgrastim. | EXPERIMENTAL | subcutaneous (SC) injection of 6 mg lipegfilgrastim |
| pegfilgrastim | ACTIVE_COMPARATOR | SC injection of 6 mg pegfilgrastim |
| XM22, 100 μg/kg BW | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| lipegfilgrastim | DRUG | 6 mg |
| pegfilgrastim | DRUG | 6 mg |
Inclusion Criteria: 1. Signed and dated Independent Ethics Committee (IEC)-approved written informed consent 2. Age ≥65 years and ≤85 years 3. Histological documentation of aggressive B cell NHL 4. Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to loca...
Lipegfilgrastim is an investigational oncology therapy developed by Teva Pharmaceutical Industries Limited (ticker TEVA). It is being studied in aggressive B cell non-Hodgkin lymphomas at high risk for R-CHOP-21-induced neutropenia, Ewing family of tumors, and rhabdomyosarcoma. It is a small molecule and remains in clinical development.
Lipegfilgrastim targets CSF3R, also known as the granulocyte colony-stimulating factor receptor, and acts as an agonist at that receptor. By activating CSF3R, it is designed to stimulate neutrophil production, which is relevant to managing neutropenia in patients receiving myelosuppressive chemotherapy such as R-CHOP-21.
Lipegfilgrastim is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the clinical program evaluating the drug in oncology indications including aggressive B cell non-Hodgkin lymphomas, Ewing family of tumors, and rhabdomyosarcoma.
Lipegfilgrastim has been studied in a Phase 3 trial and a Phase 1 trial, both of which are completed. It is an investigational agent and is not described as approved. The Phase 3 study was an active-controlled, randomized trial in elderly patients with aggressive B cell non-Hodgkin lymphomas.
Lipegfilgrastim has been evaluated in two completed trials. NCT02044276 was a Phase 3 randomized, active-controlled study of 101 elderly patients with aggressive B cell non-Hodgkin lymphomas at high risk for R-CHOP-21-induced neutropenia, run in Germany, Italy, and Spain. NCT01585649 was a Phase 1 PK/PD study of 21 children with Ewing family of tumors or rhabdomyosarcoma.