DP079 | TAFASITAMAB PLUS LENALIDOMIDE IN THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY DLBCL UNFIT FOR AUTOLOGOUS STEM CELL TRANSPLANTATION: A SYSTEMATIC REVIEW WITH META-ANALYSIS

Tafasitamab plus lenalidomide was approved by the US Food and Drug Administration in 2020 and by the European Medicines Agency in 2021 for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), based on the L-MIND study (NCT02399085). Real-world data on this treatment combination have since emerged, but with inconsistent efficacy and safety outcomes. This systematic review and meta-analysis aim to synthesize current evidence on the efficacy and safety of tafasitamab plus lenalidomide, including subgroup analyses based on prior lines of treatment. This systematic review was conducted per PRISMA guidelines and registered with PROSPERO. Studies evaluating tafasitamab plus lenalidomide in R/R DLBCL were included. Outcomes assessed were objective response rate (ORR), complete response rate (CRR), progression-free survival (PFS), overall survival (OS), and safety. Risk of bias was evaluated using the MINORS criteria. Meta-analysis was performed using a random-effects model, with subgroup analyses based on prior treatment lines. Ten studies, which were primarily observational and retrospective, were included (N=1,019 patients). The pooled ORR was 47.1% (95% CI: 35.4–59.0), with a CRR of 24.1% (95% CI: 17.8–31.0). The pooled 12-month OS and PFS rates were 44.3% (95% CI: 34.2–54.7) and 31.4% (95% CI: 19.5–44.7), respectively. Subgroup analysis revealed improved ORR (62.1%) and CRR (31.5%) in patients receiving treatment within three prior lines. Sensitivity analyses confirmed the robustness of the findings. Safety data were too heterogeneous and incomplete to allow a formal meta-analysis, therefore the findings were descriptive. Hematologic toxicities and infection-related adverse events were reported; however, no signals were observed to suggest deviation from the known safety profile of tafasitamab. Tafasitamab plus lenalidomide demonstrates promising efficacy in R/R DLBCL, particularly in patients treated earlier in the disease course. Despite high heterogeneity and moderate certainty of the evidence, the findings support the use of tafasitamab plus lenalidomide as a viable treatment option for R/R DLBCL.