General Information

Lumoxiti (moxetumomab pasudotox-tdf) is a CD22-directed cytotoxin.

Lumoxti is specifically indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

Lumoxiti is supplied as a solution for intravenous injection. The recommended dose of Lumoxiti is 0.04 mg/kg administered as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle. Continue Lumoxiti treatment for a maximum of 6 cycles, disease progression, or unacceptable toxicity.

Mechanism of Action

Lumoxiti (moxetumomab pasudotox-tdf) is a CD22-directed cytotoxin. Moxetumomab pasudotox-tdfk binds CD22 on the cell surface of B-cells and is internalized. Moxetumomab pasudotox-tdfk internalization results in ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death.

Side Effects

Adverse effects associated with the use of Lumoxiti may include, but are not limited to, the following:

infusion related reactions

edema

nausea

fatigue

headache

pyrexia

constipation

anemia

diarrhea.

laboratory abnormalities including: creatinine increased, ALT increased, hypoalbuminemia, AST increased, hypocalcemia, and hypophosphatemia

The Lumoxiti drug label comes with the following Black Box Warning: Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving Lumoxiti. If CLS is suspected delay dosing or discontinue Lumoxiti. Hemolytic Uremic Syndrome (HUS), including life-threatening cases, occurred in patients receiving Lumoxiti. Monitor hemoglobin, platelet count, serum creatinine, and ensure adequate hydration. Discontinue Lumoxiti in patients with HUS.

Clinical Trial Results

The FDA approval of Lumoxiti was based on data from a Phase III single-arm, open-label trial of Lumoxiti monotherapy in 80 patients who had received at least two prior therapies, including a purine nucleoside analog.The primary endpoint of the trial was durable complete response. Moxetumomab pasudotox showed a 75% objective response (OR) rate, a 41% complete response (CR) rate, and a 30% durable CR rate (primary endpoint). The majority of patients with a complete response had a durable response (73%; 24/33) and achieved a negative minimal residual disease (MRD) status (82%; 27/33).