Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.

Tafasitamab (MOR208), an Fc-modified, humanized, anti-CD19 monoclonal antibody, combined with the immunomodulatory drug lenalidomide was clinically active with a good tolerability profile in the open-label, single-arm, phase II L-MIND study (NCT02399085) of autologous stem-cell transplant (ASCT)-ineligible patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). To assess long-term outcomes, we report an updated analysis with ≥35 months' follow-up. Patients were aged >18 years, had 1-3 prior systemic therapies (including ≥1 CD20-targeting regimen) and Eastern Cooperative Oncology Group performance status 0-2. Patients received 28-day cycles of tafasitamab (12 mg/kg intravenously), once weekly during cycles 1-3, then every 2 weeks during cycles 4-12. Lenalidomide (25 mg orally) was administered on days 1-21 of cycles 1-12. After cycle 12, progression-free patients received tafasitamab every 2 weeks until disease progression (PD). The primary endpoint was best objective response rate (ORR). After ≥35 months' follow-up (data cut-off: October 30, 2020), ORR was 57.5% (n=46/80), including a complete response in 40.0% of patients (n=32/80) and a partial response in 17.5% of patients (n=14/80). Median duration of response (DoR) was 43.9 months (95% CI: 26.1-not reached [NR]); median overall survival (OS) was 33.5 months (18.3-NR); and median progression-free survival was 11.6 months (6.3-45.7). There were no unexpected toxicities. Subgroup analyses revealed consistent long-term efficacy results across most patient subgroups. This extended L-MIND follow-up confirms the long DoR, meaningful OS, and welldefined safety profile of tafasitamab plus lenalidomide followed by tafasitamab monotherapy in ASCT-ineligible patients with R/R DLBCL.