The Food and Drug Administration (FDA) has granted accelerated approval to Monjuvi® (tafasitamab-cxix; MorphoSys US) 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.

Tafasitamab-cxix is a humanized Fc-modified monoclonal antibody that targets CD19 antigen on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including DLBCL. It mediates B-cell lysis through apoptosis and immune effector mechanisms. 

The approval was based on data from the multicenter, open-label, single-arm phase 2 L-MIND study that evaluated the efficacy and safety of Monjuvi in combination with lenalidomide in 71 adults with relapsed or refractory diffuse DLBCL. Patients received tafasitamab-cxix 12mg/kg intravenously in combination with lenalidomide (25mg orally once daily on Days 1 to 21 of each 28-day cycle) for a maximum of 12 cycles, followed by tafasitamab-cxix monotherapy until disease progression or unacceptable toxicity. The primary end point was the overall response rate (ORR), as assessed by an independent review committee. 

Results showed that treatment was associated with an ORR of 55% (n=39; 95% CI, 43-67); 37% of patients had a complete response, while 18% had a partial response. The median duration of response (key secondary end point) was 21.7 months.

As for safety, the most common adverse reactions (≥20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. In addition, the prescribing information for Monjuvi includes warnings and precautions related to infusion-related reactions, serious or severe myelosuppression, infections and embryo-fetal toxicity.

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The FDA previously granted Priority Review, Fast Track and Breakthrough Therapy designations to Monjuvi in combination with lenalidomide for DLBCL. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Monjuvi will be available soon in single-dose vials containing 200mg of tafasitamab-cxix for reconstitution and further dilution.

For more information visit morphosys.com or incyte.com.

References

1. FDA approves Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (DLBCL). https://www.businesswire.com/news/home/20200731005497/en/FDA-Approves-Monjuvi%C2%AE-tafasitamab-cxix-Combination-Lenalidomide-Treatment. Accessed August 3, 2020. 

2. Monjuvi [package insert]. Boston, MA: MorphoSys US Inc.; 2020.