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 therapy being studied for the treatment of acute myeloid leukemia (AML), a cancer of the blood and bone marrow. It is specifically being evaluated in patients with newly diagnosed AML. APVO436 has not been approved by the FDA and remains in clinical development.
APVO436 is being developed by Aptevo Therapeutics Inc., a clinical-stage biotechnology company. Aptevo Therapeutics trades on the Nasdaq under the ticker symbol APVO. The company is the sponsor of the ongoing clinical study of APVO436 in acute myeloid leukemia.
APVO436 is in Phase 1 clinical development. The ongoing trial is a Phase 1b/2 study, and the drug has not yet advanced to later-stage or pivotal testing. It is investigational and has not received FDA approval for any indication.
APVO436 is being evaluated in one active clinical trial, NCT06634394, titled "APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML." The trial is currently recruiting participants in the United States and has an planned enrollment of 39 patients aged 18 years and older.
No, APVO436 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for acute myeloid leukemia. Approval status has not been granted, and the therapy remains available only through clinical trial participation.