The FDA ( Food and Drug Administration ) has granted accelerated approval to Monjuvi ( Tafasitamab-cxix, Tafasitamab ), a CD19-directed cytolytic antibody, indicated in combination with Lenalidomide for 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.
The efficacy of Tafasitamab-cxix with Lenalidomide was evaluated in L-MIND, an open label, multicenter single-arm trial in 81 patients.
Patients received Tafasitamab-cxix 12 mg/kg intravenously with Lenalidomide ( 25 mg orally on days 1 to 21 of each 28-day cycle ) for maximum of 12 cycles, followed by Tafasitamab-cxix as monotherapy.
Efficacy was based on best overall response rate ( ORR ), defined as complete and partial responders, and response duration ( DOR ), as assessed by an independent review committee.
The best ORR in 71 patients with a diagnosis of DLBCL confirmed by central pathology was 55% ( 95% CI: 43%, 67% ), with complete responses in 37% and partial responses in 18% of patients.
Median response duration was 21.7 months ( range: 0, 24 ).
The most common adverse reactions ( 20% or more ) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.
The recommended Tafasitamab-cxix dose is 12 mg/kg as an intravenous infusion.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( Xagena )
Source: FDA, 2020