Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Balugrastim
Neugranin · 2 trials · 1 indication
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<0.5 x 10\^9/liter \[L\]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle.
Severe neutropenia was defined as Grade 4 neutropenia (ANC \<0.5 x 10\^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<0.5 x 10\^9/liter \[L\]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle.
| Arm | Type | Description |
|---|---|---|
| Double-Blind Phase: Pegfilgrastim | ACTIVE_COMPARATOR | Participants will receive pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
| Double-Blind Phase: Neugranin 40 mg | EXPERIMENTAL | Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
| Open-Label Phase: Neugranin 40 mg | EXPERIMENTAL | Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. |
| Pilot Phase: Balugrastim Low Dose | EXPERIMENTAL | Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Pilot Phase: Balugrastim Medium Dose | EXPERIMENTAL | Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Pilot Phase: Balugrastim High Dose | EXPERIMENTAL | Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Pilot Phase: Pegfilgrastim | ACTIVE_COMPARATOR | Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Main Phase: Balugrastim Medium Dose | EXPERIMENTAL | Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Main Phase: Balugrastim High Dose | EXPERIMENTAL | Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Main Phase: Pegfilgrastim | ACTIVE_COMPARATOR | Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). |
| Name | Type | Description |
|---|---|---|
| Neugranin | BIOLOGICAL | Neugranin will be administered per dose and schedule specified in the arm description. |
| Pegfilgrastim | BIOLOGICAL | Pegfilgrastim will be administered per dose and schedule specified in the arm description. |
| Chemotherapy | DRUG | The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination |
| Balugrastim | BIOLOGICAL | Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description. |
| Chemotherapy Regimen | DRUG | The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
Inclusion Criteria: * Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel) Exclusion Criteria: * Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)
Neugranin is an investigational monoclonal antibody being developed for chemotherapy-induced neutropenia, a condition of low white blood cell counts caused by cancer treatment. It is being studied in the hematology therapeutic area. The drug is currently in Phase 3 clinical development and is not approved by the FDA.
Neugranin is being developed by Teva Pharmaceutical Industries Limited, whose stock trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug for chemotherapy-induced neutropenia.
Neugranin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its safety and efficacy in patients with chemotherapy-induced neutropenia.
Neugranin has one completed Phase 3 clinical trial, registered as NCT01126190. The trial, titled "Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel," enrolled 381 participants with chemotherapy-induced neutropenia. It was conducted in Bulgaria, Romania, Russia, Serbia, and Ukraine.
Yes, Neugranin is a monoclonal antibody. It is being investigated as a treatment for chemotherapy-induced neutropenia. The drug is currently in Phase 3 clinical trials, and its development is led by Teva Pharmaceutical Industries Limited.