The FDA approved Tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Mechanism of action:
Tafasitamab targets CD19, a protein found on the surface of B-cells, triggering the immune system to destroy cancerous B-cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and apoptosis.
Clinical Trial results
A phase III trial, inMIND showed that adding tafasitamab to lenalidomide and rituximab improved progression-free survival (PFS) in patients with relapsed or refractory FL. The median PFS was 22.4 months for the tafasitamab combination versus 13.9 months for the placebo combination, reducing the risk of disease progression, relapse, or death by 57%.
Dosing and Administration:
The recommended tafasitamab-cxix dosage is 12 mg/kg administered via intravenous infusion, with a maximum of 12 cycles
Safety:
The drug label includes warnings for infusion-related reactions, myelosuppression, and infections.