Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pivekimab Sunirine · 2 trials · 1 indication
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
CR per modified 2022 European LeukemiaNet (ELN) response criteria in AML
The time (in number of days) from randomization to death due to any cause.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of participants with protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with pivekimab sunirine (PVEK). Severity of TEAEs will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Maximum observed serum/plasma concentration of intact ADC.
Maximum observed serum/plasma concentration of FGN849 payload.
Area under the concentration-time curve of intact ADC.
Area under the concentration-time curve of FGN849 payload.
Time to Cmax of intact ADC.
Time to Cmax of payload.
| Arm | Type | Description |
|---|---|---|
| Phase 2: Arm A - PVEK, VEN, and AZA | EXPERIMENTAL | Participants will receive PVEK, VEN, and AZA |
| Phase 2: Arm B - VEN and AZA | ACTIVE_COMPARATOR | Participants will receive VEN and AZA |
| Phase 3: Arm A - PVEK, VEN, and AZA | EXPERIMENTAL | Participants will receive PVEK, VEN, and AZA |
| Phase 3: Arm B - PVEK-Placebo, VEN, and AZA | EXPERIMENTAL | Participants will receive PVEK-Placebo, VEN, and AZA |
| Cohort 1: Pivekimab Sunirine Ages 2 to < 6 Years | EXPERIMENTAL | Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. If enrolled, subjects aged 6 months to less than 2 years will be included in Cohort 1 |
| Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years | EXPERIMENTAL | Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. |
| Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years | EXPERIMENTAL | Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. |
| Name | Type | Description |
|---|---|---|
| Pivekimab Sunirine | DRUG | Intravenous |
| Venetoclax | DRUG | Orally |
| Azacitidine | DRUG | Intravenous Or Subcutaneous |
| Matching Placebo for PVEK | DRUG | Intravenous |
Inclusion Criteria: 1. Participants must have newly diagnosed, untreated confirmed acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organization (WHO) criteria with a projected life expectancy of at least 12 weeks. 2. CD123-positive 3. Ineligible for intensive induction...
Pivekimab Sunirine is an investigational monoclonal antibody being developed by AbbVie Inc. (ticker ABBV) for the treatment of acute myeloid leukemia (AML). It is currently in Phase 2 clinical development. It is an antibody-based therapy and is being studied in biomarker-selected adult and pediatric patient populations with AML.
Pivekimab Sunirine is being studied for the treatment of acute myeloid leukemia (AML). The Phase 2 trial evaluates it in combination with oral venetoclax and intravenous or subcutaneous azacitidine in adult participants with AML. A separate Phase 1 trial studies it in pediatric participants with relapsed or refractory AML.
Pivekimab Sunirine is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug in acute myeloid leukemia, including a Phase 2 combination study in adults and a Phase 1 study in pediatric patients.
Pivekimab Sunirine is in Phase 2 clinical development for acute myeloid leukemia. It is an investigational agent and has not been approved by the FDA. Two trials are currently active and recruiting: a Phase 2 study in adults and a Phase 1 study in pediatric participants.
Pivekimab Sunirine is being evaluated in two active, recruiting trials. NCT07581002 is a Phase 2 study of intravenous Pivekimab Sunirine combined with oral venetoclax and intravenous or subcutaneous azacitidine in adults with acute myeloid leukemia, enrolling 660 participants. NCT07306832 is a Phase 1 study in pediatric participants with relapsed or refractory AML, enrolling 18 participants.
Yes. Pivekimab Sunirine is a monoclonal antibody, an antibody-based therapeutic modality. It is being developed as an intravenous therapy and studied in biomarker-selected patients with acute myeloid leukemia. The clinical program includes a randomized, double-blind, controlled Phase 2 trial in adults and a Phase 1 pediatric trial.