Large B-cell lymphoma is an aggressive type of lymphoma that can arise in occur in lymph nodes or outside of the lymphatic system. Patients with relapsed or refractory diffuse large B-cell lymphoma have limited treatment options with poor outcomes. This study aims to evaluate the safety and antitumor activity of tafasitamab-lenalidomide combination therapy in patients with relapsed or refractory diffuse large B-cell lymphoma.

This open-label, multicenter, single-arm, phase-2 study included a total of 80 patients older than 18 years with histologically confirmed, relapsed, or refractory diffuse large B-cell lymphoma. The patients were randomly assigned to receive coadministered intravenous tafasitamab and oral lenalidomide. The primary outcome of the study was a centrally-assessed objective response.

During a median follow-up of 13.2 months, 48 patients (60%) who received the combination therapy had an objective response, of whom 34 patients (43%) had an objective response, and 14 (18%) had a partial response. Commonly occurring treatment-related adverse events of grade 3 or worse were neutropenia (48%), thrombocytopenia (17%), and febrile neutropenia (12%). Serious events occurred in 51% of the patients, but no deaths were reported. 

The research concluded that tafasitamab-lenalidomide combination therapy resulted in a high rate of objective response and was also well-tolerated.