US FDA approves tafasitamab in combination with lenalidomide for treatment of DLBCL

August 1, 2020 0 By FM

The US FDA has recently approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This includes DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab-cxix is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. The combination therapy becomes a second-line treatment for adult patients who progressed during or after first-line therapy.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, characterised by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.

The approval was based on data from the phase 2 L-MIND study, an open-label, multicentre, single-arm trial of tafasitamab-cxix in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL.

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.

The warnings and precautions for tafasitamab-cxix included infusion-related reactions (6%), serious or severe myelosuppression (including neutropenia (50%), thrombocytopenia (18%), and anaemia (7%), infections (73%) and embryo-fetal toxicity. Neutropenia led to treatment discontinuation in 3.7% of patients.