Tafasitamab regimen improves PFS in advanced follicular lymphoma
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The addition of tafasitamab-cxix to lenalidomide and rituximab improved outcomes for patients with relapsed or refractory follicular lymphoma, according to the agent’s manufacturer.
Tafasitamab-cxix (Monjuvi; MorphoSys, Incyte) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody.
The agent is approved in the United States for use with lenalidomide for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified — including DLBCL arising from low-grade lymphoma — who are ineligible for autologous stem cell transplant.
The randomized phase 3 inMIND trial included 654 adults with relapsed or refractory follicular lymphoma (grade 1 to grade 3A) or nodal, splenic or extranodal marginal zone lymphoma.
PFS by investigator assessment among patients with follicular lymphoma served as the trial’s primary endpoint. Key secondary endpoints included PFS per investigator assessment in the overall study population, as well as PET complete response and OS among patients with follicular lymphoma.
The trial met its primary and key secondary endpoints.
Researchers observed no new safety signals with tafasitamab. The most common adverse events reported among patients treated with tafasitamab include fatigue or weakness, cough, fever, diarrhea, respiratory tract infection, swelling of the hands or lower legs, and decreased appetite.
Incyte officials expect to file a supplemental biologics license application by the end of this year for treatment of patients with follicular lymphoma who failed at least one previous systemic anti-CD20 immunotherapy or chemoimmunotherapy.