https://orcid.org/0000-0001-9062-077X
Key Points
T/L provides durable responses and good survival in R/R DLBCL ineligible for intensive therapy, regardless of age or comorbidities.
Optimal T/L outcomes occur in non-refractory, non-DH DLBCL in 1st/2nd relapse with good ECOG PS (0-1): patient selection is critical.
Relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) remains challenging to treat, especially in patients ineligible for intensive therapy or CAR-Ts. Tafasitamab plus lenalidomide (T/L) is an effective option based on the phase 2 L-MIND trial findings, although real-world evidence studies have not consistently confirmed these results. We aimed to describe real-world outcomes of R/R DLBCL treated with T/L in Spain. A total of 99 patients received at least one dose of tafasitamab (ITT cohort), with 83 completing at least one full cycle of T/L (efficacy cohort). Respectively for ITT and efficacy cohorts, at a median follow-up of 19.2 and 21.6 months, the overall response rate was 51% and 61% (CR: 35% and 42%). Median duration of response was not reached, and patients achieving a CR had excellent outcomes. The median PFS were 4.9 and 10.9 months, and overall survival (OS) were 12.2 and 21.8 months, respectively for both ITT and efficacy cohorts. Neither age nor CIRS influenced survival. Better PFS was obtained in first/second relapse but only poor ECOG PS 2-4 (HR 2.1), double-hit lymphoma (HR 2.5) and those with refractory/progressing disease after the previous therapy (HR 2.1), were independently associated with worse PFS. Treatment was generally well-tolerated, with manageable toxicity. Relative dose-intensity (RDI) of lenalidomide significantly affected response, PFS and OS. In summary, T/L is both well-tolerated and effective, irrespective of age or comorbidities. Our findings provide valuable insights into the real-world application of T/L and reinforce its role as a key treatment option for patients with R/R DLBCL.
