Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APVO436 · 1 trial · 1 indication
Incidence and severity of treatment emergent adverse events (TEAEs), including ≥Grade 3 adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs: ≥Grade 2 infusion related reaction (IRR), ≥Grade 2 cardiac toxicity, and ≥Grade 2 neurotoxicity as complication of cytokine release syndrome \[CRS\]).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm APVO436 in combination with Venetoclax and Azacitidine | EXPERIMENTAL | APVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML. |
| Name | Type | Description |
|---|---|---|
| APVO436 | DRUG | Infusion drug administered as a 4 hour infusion. |
| Venetoclax | DRUG | Oral tablet given on days 1 through 22, of a 28 day cycle. |
| Azacitidine | DRUG | Intravenous infusion given on days 1-8 of a 28 day cycle |
Inclusion Criteria: * 1\. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated. 3\. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]). Confirmation...
APVO436 is an investigational small molecule being developed for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in patients with newly diagnosed AML.
APVO436 is being developed by Aptevo Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol APVO. The company is conducting clinical trials to evaluate the safety and efficacy of APVO436 in patients with Acute Myeloid Leukemia.
APVO436 is in Phase 1 clinical development. It is currently being evaluated in a Phase 1b/2 study in patients with newly diagnosed Acute Myeloid Leukemia (AML). The drug is investigational and has not been approved by the FDA or any other regulatory agency.
APVO436 is being studied in a Phase 1b/2 clinical trial with the identifier NCT06634394. This trial is recruiting patients with newly diagnosed Acute Myeloid Leukemia (AML) in the United States. The study is an open-label, uncontrolled trial with an enrollment target of 39 participants aged 18 years and older.
No, APVO436 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Acute Myeloid Leukemia (AML). The drug is being evaluated in clinical trials to determine its safety and efficacy, but it has not yet received marketing approval.