Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rolontis®, SPI-2012, HM10460A
Eflapegrastim · 6 trials · 5 indications
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.
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.
PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.
PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve
| Arm | Type | Description |
|---|---|---|
| (Arm 1): SPI-2012 and TC | EXPERIMENTAL | At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment. |
| (Arm 2): Pegfilgrastim and TC | EXPERIMENTAL | At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment. |
| Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \[G-CSF\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. |
| Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. |
| 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). |
| Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 milligram/ square metre (mg/m\^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| 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. |
| SPI-2012 | EXPERIMENTAL | * SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF per cycle) * Supplied in 1 mL prefilled, single-use syringes for subcutaneous injection * Administered on Day 2 of each cycle after TC administration |
| Name | Type | Description |
|---|---|---|
| SPI-2012 | DRUG | Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle |
| Pegfilgrastim | DRUG | Subcutaneous injection administered on Day 2 of each cycle. |
| Docetaxel | DRUG | 75mg/m\^2 IV infusion administered on Day 1 of each cycle |
| Cyclophosphamide | DRUG | 600mg/m\^2 IV infusion administered on Day 1 of each cycle |
| 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. |
Key Inclusion Criteria: * New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer * Candidate for adjuvant or neo-adjuvant TC chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 * Absolute neut...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Eflapegrastim is being studied for neutropenia in patients receiving myelosuppressive chemotherapy, including those with solid tumors, lymphomas, and breast cancer. It is also being evaluated in pediatric patients with solid tumors or lymphomas. It is an investigational therapy and has not been approved for any indication.
Eflapegrastim targets CSF3R, the colony stimulating factor 3 receptor. It acts as an agonist at this receptor, which is the same target as endogenous granulocyte colony stimulating factor (G-CSF). This receptor is involved in the production and differentiation of neutrophils.
Eflapegrastim is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company is responsible for the clinical development program of this investigational agent.
Eflapegrastim is in Phase 1 clinical development according to the overall program status. One completed Phase 1 trial and one recruiting Phase 2 trial are listed. It remains investigational and has not been approved by the FDA or any regulatory agency.
Eflapegrastim has been studied in two registered clinical trials. NCT04187898 was a completed Phase 1 study in breast cancer patients with neutropenia. NCT04570423 is a recruiting Phase 2 study evaluating safety and pharmacokinetics in pediatric participants with solid tumors or lymphomas receiving myelosuppressive chemotherapy.