Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eflapegrastim · 2 trials · 4 indications
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is any AE that occurs from the first dose of the study drug until 35 days after the last dose of study drug, or on the day a new/additional chemotherapy regimen, or on the day another granulocyte-colony stimulating factor (G-CSF) is administered.
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10\^9/liter (L) after the expected nadir.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: ≥12 to <17 years | EXPERIMENTAL | Participants will receive a SC injection of eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected). |
| Cohort 2: ≥6 to <12 years | EXPERIMENTAL | Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected). |
| Cohort 3: ≥2 to <6 years | EXPERIMENTAL | Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected). |
| Cohort 4: ≥1 month to <2 years | EXPERIMENTAL | Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected). |
| Early Phase: Eflapegrastim @ 30mins post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg granulocyte colony-stimulating factor \[G-CSF\]). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 30 minutes from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Early Phase: Eflapegrastim @ 3 hours post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 3 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Early Phase: Eflapegrastim @ 5 hours post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 5 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days. |
| Expansion Phase: Eflapegrastim @ 30 mins post TC | EXPERIMENTAL | Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycles 1-4: Administered on the same day as TC chemotherapy, 30 minutes following the end of TC administration. Each cycle is 21 days. |
| Name | Type | Description |
|---|---|---|
| Eflapegrastim | DRUG | Eflapegrastim supplied in prefilled, single-use syringes for SC injection. |
| Chemotherapy | DRUG | Chemotherapy agents may include doxorubicin, ifosfamide, docetaxel, CHOP regimen, etoposide, cyclophosphamide and vincristine which will be administered as per standard of care per the Primary Care physician's treatment plan. |
| Docetaxel | DRUG | 75 mg/m\^2 IV infusion. Administered on Day 1 of each cycle. |
| Cyclophosphamide | DRUG | 600 mg/m\^2 IV infusion. Administered on Day 1 of each cycle. |
Inclusion Criteria: 1. Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement. 2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Eflapegrastim is an investigational monoclonal antibody being studied for the treatment of neutropenia and solid tumors. It is being evaluated in patients with breast cancer who develop neutropenia after chemotherapy, as well as in pediatric patients with solid tumors or lymphomas receiving myelosuppressive chemotherapy.
Eflapegrastim is being developed by Assertio Holdings, Inc., a company traded on the stock exchange under the ticker ASRT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology settings.
Eflapegrastim is in clinical development. A Phase 1 study in patients with breast cancer and neutropenia has been completed, and a Phase 2 study in pediatric patients with solid tumors or lymphomas is currently recruiting participants. The drug is investigational and not yet approved.
Eflapegrastim has been studied in two clinical trials. NCT04187898 is a completed Phase 1 study evaluating the duration of severe neutropenia after same-day dosing in breast cancer patients. NCT04570423 is a recruiting Phase 2 study assessing safety and pharmacokinetics in pediatric patients with solid tumors or lymphomas.
Eflapegrastim is a monoclonal antibody designed to target and modulate biological pathways involved in neutrophil production. By binding to specific molecular targets, it aims to reduce the severity and duration of neutropenia caused by myelosuppressive chemotherapy in cancer patients.
Eflapegrastim is a distinct investigational drug developed by Assertio Holdings. It is not known to be identical to any other approved medication. Its unique mechanism and formulation are being studied to determine its potential role in managing chemotherapy-induced neutropenia.