Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety in the phase II L-MIND study

Abstract

Tafasitamab, an anti-CD19 immunotherapy, is used with lenalidomide for patients with autologous stem cell transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) based on the results of the phase II L-MIND study (NCT02399085). We report the final 5-year analysis. Eighty patients (≥18 years, 1–3 prior systemic therapies, ECOG PS 0–2) received co-administered tafasitamab and lenalidomide for up to 12 cycles, followed by tafasitamab monotherapy until disease progression (PD) or unacceptable toxicity. Primary endpoint was best objective response rate (ORR). Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Exploratory analyses evaluated efficacy endpoints by prior lines of therapy (pLoT). At data cut-off on November 14, 2022, ORR was 57.5%, with complete response (CR) of 41.3% (n=33), which was consistent with prior analyses. With median follow-up (mFU) of 44.0 months, median DoR was not reached. Median PFS was 11.6 months [95% CI, 5.7–45.7] (mFU 45.6), and median OS was 33.5 months [95% CI, 18.3–NR] (mFU 65.6). Patients with 1 pLoT (n=40) showed higher ORR (67.5%; 52.5% CR) compared with patients with ≥2 pLoT (n=40; 47.5%; 30% CR), but median DoR was not reached in either subgroup. Other exploratory analyses revealed consistent long-term efficacy results across subgroups. Adverse events were consistent with previous reports and manageable, and their frequency decreased during tafasitamab monotherapy, with no new safety concerns. This final 5-year analysis of L-MIND demonstrates that this immunotherapy combination is well tolerated and has long-term clinical benefit with durable responses.