DP005 | REAL-WORLD PROSPECTIVE OBSERVATIONAL STUDY OF TAFASITAMAB WITH LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: PRELIMINARY RESULTS FROM THE ITALIAN PRO-MIND STUDY

Tafasitamab, a humanized anti-CD19 monoclonal antibody, has shown clinical efficacy in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in clinical trials when combined with lenalidomide. Although some retrospective real-world studies have been reported on this combination, prospective data remain limited. PRO-MIND is the first prospective, observational real-world study designed to assess tafasitamab plus lenalidomide. The study was conducted at 30 centers across Italy. The study aim was to evaluate clinical outcomes and health-related quality of life (HRQoL) in patients with R/R DLBCL treated in routine practice. The study began in December 2023, with data cutoff set for January 31, 2025. This abstract reports results from the first interim analysis focused on clinical outcomes; HRQoL data are not yet available. Adults (≥18 years) with R/R DLBCL, ineligible for autologous stem-cell transplant, were enrolled if tafasitamab plus lenalidomide was prescribed in routine practice and started after informed consent. As per the Agenzia Italiana Del Farmaco registry, treatment had to be in second, third, or fourth line. Clinical characteristics, treatment exposure, safety, and response were collected and analyzed descriptively. Fifty-two patients were enrolled (27 male, 25 female) with median age 78 years (range 60–86). Overall, 52% had primary refractory disease, defined as no response or progression during or within six months of frontline therapy. Most (81%) had Ann Arbor stage III/IV disease, and 86% had ECOG 0–1. DLBCL not otherwise specified accounted for 81% of cases; 6% had transformed grade 3B follicular lymphoma. Bulky disease was present in 15%; median lactate dehydrogenase was 229 U/L. A total of 62% had received one prior line. Median number of cycles was three (range 2.9–4.0); lenalidomide was discontinued in 11%. After a median follow-up of 87 days (range 0–379), best ORR was 55% (95% CI: 41.5–68.5), with 29% best CR (95% CI: 16.7–41.3) and 26% best PR (95% CI: 14.1–37.9). PFS and OS data are immature. Most common adverse events were infections (41%), neutropenia (19%), diarrhea (15%), neuropathy (8%), and rash (8%). This interim analysis contributes additional real-world evidence on the use of tafasitamab plus lenalidomide in patients with R/R DLBCL. The advanced age of this population and high prevalence of primary refractory disease reflect a difficult clinical setting. Updated efficacy and survival data will be presented.