Clinical trials of tafasitamab

Tafasitamab was evaluated in combination with lenalidomide and tafasitamab monotherapy inL-MIND, an open-label, multicenter, single-arm trial. Eligible patients have relapsed or refractory diffuse large B-cell lymphoma after 1-3 prior lines of systemic therapy, including CD20-directed cytolytic antibodies, and are ineligible for autologous stem cell transplantation (ASCT) following high-dose chemotherapy (HDC). Patients received tafracetamumab 12 mg/kg intravenously in combination with lenalidomide (25 mg orally on days 1 to 21 of each 28-day cycle) for up to 12 cycles, followed by tafracetamumab monotherapy until disease progression or unacceptable toxicity.

Among the 71 patients with central laboratory-confirmed diffuse large B-cell lymphoma who received the combination therapy, 49% had received one prior therapy and 51% had received 2 to 4 prior therapies. Thirty-two patients (45%) were refractory to their last previous treatment, and 30 patients (42%) were refractory to rituximab. Nine patients (13%) had previously undergone ASCT. The main reasons why patients are not suitable for ASCT include age, refractory salvage chemotherapy, comorbidities, and refusal of high-dose chemotherapy/ASCT.

Efficacy was based on optimal overall response rate (ORR), defined as complete and partial responders and duration of response. The best ORR of 71 patients with tafracetamumab confirmed by central pathology was 55%, with 37% of patients having a complete response and 18% of patients having a partial response. The median duration of response was 21.7 months.