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Tafasitamab Associated With Meaningful, Well-Defined, Long-Term Outcomes in R/R DLBCL
An updated analysis of the phase 2 L-MIND study was developed to assess long-term outcomes of tafasitamab plus lenalidomide in relapsed or refractory (R/R) patients with diffuse large B-cell lymphoma (DLBCL; Haematologica. Sep;106(9):2417-2426).
“Tafasitamab, an Fc-modified, humanized, anti-CD19 monoclonal antibody, combined with the immunomodulatory drug lenalidomide was clinically active with a good tolerability profile in this open-label, single-arm phase 2 trial of patients with R/R DLBCL,” explained Johannes Duell, Universitätsklinik Würzburg, Germany, and co-researchers.
After 35 months or more of follow-up time, 80 patients were evaluated. Baseline characteristics were identified as all patients being older than 18 with at least 1 to 3 prior lines of systemic therapies (including 1 or more CD20-targeting regimen) and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
“Patients received 28-day cycles of tafasitamab (12 mg/kg intravenously), once weekly during cycles 1-3, then 2 weeks during cycles 4-12. Lenalidomide (25 mg orally) was administered on days 1-21 of cycles 1-12. After cycle 12, progression-free patients received tafasitamab every 2 weeks until disease progression,” continued Dr Duell and co-authors.
After ≥35 months of follow-up, the objective response rate (ORR) was 57.5 percent, with a complete response (CR) in 40 percent of patients, and a partial response (PR) in 17.5 percent of patients.
Further, the median duration of response (DOR) was 43.9 months (95% CI, 26.1-not reached), the median overall survival (OS) rate was 33.5 months (95% CI, 18.3-not reached) and the median progression-free survival (PFS) rate was 11.6 months (95% CI, 6.3-45.7).
There were no unexpected toxicities reported.
“Subgroup analyses revealed consistent long-term efficacy results across most subgroups of patients. This extended follow-up of L-MIND confirms the long duration of response, meaningful OS, and well-defined safety profile of tafasitamab plus lenalidomide followed by tafasitamab monotherapy in patients with R/R DLBCL for autologous stem cell transplantation,” concluded Dr Duell, et al.—Alexa Stoia