RE-MIND: A Comparison of Tafasitamab (MOR208) + Lenalidomide (L-MIND) Versus Lenalidomide Monotherapy (Real-World Data) in Transplant-Ineligible Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Context: Tafasitamab (MOR208), a humanized anti-CD19 antibody, combined with lenalidomide (LEN) showed encouraging results in the Phase II, single-arm L-MIND study (NCT02399085) of patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplantation (ASCT). Objective: To generate a LEN monotherapy matched comparator cohort for L-MIND using patient-level data to isolate the tafasitamab contribution to the efficacy of the tafasitamab + LEN combination. Design: RE-MIND (NCT04150328), a retrospective observational study, used a Nearest Neighbor ePS-based 1:1 Matching methodology to balance the LEN monotherapy cohort (observational data) and combination cohort (derived from L-MIND) for nine prespecified baseline covariates: age, Ann Arbor stage, last therapy refractoriness, number of prior therapy lines, primary refractoriness, prior ASCT, LDH, neutropenia, and anemia. The primary analysis set included matched patients who received a LEN starting dose of 25 mg/day (as in L-MIND) with sufficient follow-up. Patients: LEN monotherapy-treated patients from the US and EU who met the L-MIND-aligned eligibility criteria: adult patients with R/R DLBCL; 1–3 prior systemic therapies, including 1 CD20-targeting regimen; ASCT-ineligible. Baseline characteristics, LEN dosing, and patient outcomes were collected retrospectively from health records. Main outcome measures: The primary endpoint was investigator-assessed best objective response rate (ORR). Secondary endpoints included overall survival (OS) and complete response (CR) rates. Results: 490 patients were enrolled, of which 140 fulfilled the ePS matching criteria. Following matching, the primary analysis set included 76 patients from each cohort. Baseline characteristics were comparable. The primary endpoint was met. Best ORR was significantly higher in the combination cohort (67.1%) versus the monotherapy cohort (34.2%) (odds ratio 3.89; 95% confidence interval [CI]: 1.90–8.14; p Conclusions: Significantly better ORR, CR, and OS indicate potential synergistic effects of the tafasitamab + LEN combination in ASCT-ineligible R/R DLBCL. RE-MIND demonstrates the utility of real-world data in interpreting non-randomized trials.