General Information

Monjuvi (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.

Monjuvi is specifically indicated for use in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Monjuvi is supplied as a solution for intravenous administration. The recommended dose of Monjuvi is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule as follows. Administer Monjuvi in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continue Monjuvi as monotherapy until disease progression or unacceptable toxicity.

Cycle 1: Days 1, 4, 8, 15 and 22

Cycles 2 and 3: Days 1, 8, 15 and 22

Cycle 4 and beyond: Days 1 and 15

Pre-medications: Administer pre-medications 30 minutes to 2 hours prior to starting Monjuvi infusion to minimize infusion-related reactions. Pre-medications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids. For patients not experiencing infusion-related reactions during the first 3 infusions, pre-medication is optional for subsequent infusions. If a patient experiences an infusion-related reaction, administer pre-medications before each subsequent infusion.

Please see drug label for any additional dose modifications.

Mechanism of Action

Monjuvi (tafasitamab-cxix) is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In studies conducted in vitro in DLBCL tumor cells, tafasitamab-cxix in combination with lenalidomide resulted in increased ADCC activity compared to tafasitamab-cxix or lenalidomide alone.

Clinical Trial Results

Monjuvi was approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The accelerated approval of Monjuvi was based on data from the Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide in 71 adult patients with relapsed or refractory DLBCL. Eligible patients had relapsed or refractory DLBCL after 1 to 3 prior systemic therapies, including a CD20-directed cytolytic antibody, and were not candidates for high dose chemotherapy (HDC) followed by autologous stem cell transplantation (ASCT). Patients received Monjuvi 12 mg/kg intravenously in combination with lenalidomide (25 mg orally on Days 1 to 21 of each 28-day cycle) for maximum of 12 cycles, followed by Monjuvi as monotherapy until disease progression or unacceptable toxicity as follows: • Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle; • Cycle 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle; • Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle. Results from the study showed an overall response rate (ORR) of 55% (primary endpoint), including a complete response (CR) rate of 37% and a partial response rate (PR) of 18%. The median duration of response (mDOR) was 21.7 months (key secondary endpoint).