Clinical benefit of tafasitamab plus lenalidomide in relapsed or refractory diffuse large Bcell lymphoma: real-world data from the EarlyMIND study

Abstract

Tafasitamab combined with lenalidomide was approved in Europe in 2021 for transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma. Approval was based on the L-MIND study, which demonstrated a 57.5% overall response rate (ORR), 41.3% complete response (CR) rate, 12.1 months median progression-free survival (PFS), and 33.5 months median overall survival (OS) at five years. The multicenter retrospective EarlyMIND study analyzed real-world efficacy and treatment patterns of patients receiving tafasitamab plus lenalidomide for second (2L cohort) to fourth (3L + 4L cohort) line in the French Early Access Program. Outcomes were analyzed overall and according to number of previous lines. Post hoc analyses were conducted on subgroups based on prognostic factors, performance status, primary refractoriness, cell of origin, and treatment response. Overall, 186 patients were included (2L: n=105; 3L + 4L: n=81). Median age was 78 years; most patients had early relapsed disease (71.2%), including 60.2% with primary refractory disease. At median follow-up of 8.2 months, best ORR was 46.8%, with CR rate of 29%. ORR was greater in 2L (50.5%) versus 3L + 4L (42%). Median PFS and OS were 4.7 and 10 months, respectively in the overall population, 5.4 and 10.6 months in 2L, and 3.6 and 8.2 months in 3L + 4L. Long-lasting responses were observed in patients achieving CR, with median duration of response, PFS, and OS not reached. Median time to CR as best OR was four cycles, regardless of treatment line. Despite involving a frail population with high-risk disease characteristics, results of this large real-world European retrospective study on tafasitamab plus lenalidomide are encouraging, with almost one third of patients experiencing long-lasting CR.