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 drug being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in clinical development, with trials evaluating it in both pediatric and adult patients with relapsed or refractory AML, as well as in combination with other therapies for adult AML.
Pivekimab Sunirine is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Acute Myeloid Leukemia.
Pivekimab Sunirine is in Phase 2 clinical development for Acute Myeloid Leukemia. A Phase 2 trial is currently recruiting adult participants to study the drug in combination with venetoclax and azacitidine. Additionally, a Phase 1 trial is recruiting pediatric participants with relapsed or refractory AML.
Pivekimab Sunirine is being studied in two active clinical trials. NCT07306832 is a Phase 1 trial in pediatric participants with relapsed or refractory AML. NCT07581002 is a Phase 2 trial in adult participants with AML, evaluating the drug in combination with venetoclax and azacitidine. Both trials are currently recruiting.
In clinical trials, Pivekimab Sunirine is administered intravenously (IV). The Phase 1 pediatric trial assesses IV administration of the drug alone, while the Phase 2 adult trial evaluates IV Pivekimab Sunirine in combination with oral venetoclax and IV or subcutaneous azacitidine.