Tafasitamab plus lenalidomide and tafasitamab maintenance resulted in durable responses, with a median duration of response (DOR) not reached among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in the phase 2 L-MIND trial.
Patients who had received only 1 prior line of therapy demonstrated better outcomes than patients who were more heavily pretreated.
The 5-year update of this trial was presented by Johannes Duell, MD, of the Medizinische Klinik und Poliklinik II at the Universitätsklinikum Würzburg, Germany, at the AACR Annual Meeting 2023.
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The open-label, single-arm L-MIND study (ClinicalTrials.gov Identifier: NCT02399085) treated patients with DLBCL who were not eligible for an autologous stem cell transplant with tafasitamab plus lenalidomide for 12 cycles, followed by tafasitamab alone until disease progression. The primary endpoint was objective response rate (ORR) and secondary endpoints included progression-free survival (PFS), DR, overall survival (OS) and safety.
At baseline, the median age was 72, with 56.2% of patients older than age 70, and 53.8% of patients were female. There were 75% of patients with Ann Arbor Stage III-IV disease and 50% had an International Prognostic Index score of 3 to 5. There were 43.8% of patients who were refractory to their prior treatment and 18.8% who were primary refractory. The cell of origin was germinal center B-cell (GCB) among 47.5% of patients, non-GCB among 27.5%, and it was unknown for the remaining 25%.
With a median of 44 months of follow-up for the entire cohort, the ORR was 57.5%. The ORR was higher among patients who had received only 1 prior line of therapy at 67.5%, whereas 47.5% of patients who had received multiple prior lines of treatment experienced a response.
The complete response rate was 41.3% overall, 52.5% among patients who had received 1 prior line of therapy, and 30% among patients who had received multiple lines of therapy.
The median DOR was not reached in all cohorts. The median PFS was 11.6 months for the entire cohort. The median PFS of the cohort with 1 prior line of therapy was 23.5 months, whereas patients with multiple prior lines of therapy demonstrated a median PFS of 7.6 months.
The frequency of treatment-emergent adverse events (TEAEs) decreased over time. Diarrhea and peripheral edema were the most common TEAEs during the initial treatment period with tafasitamab plus lenalidomide.
“These long-term data suggest that this immunotherapy may have curative potential, which is being explored in further studies,” Dr Duell noted.
Disclosures: This research was supported by MorphoSys AG. Please see the original reference for a full list of disclosures.
Reference
Duell J, Abrisqueta P, Andre M, et al. Five-year efficacy and safety of tafasitamab in patients with relapsed or refractory DLBCL: Final results from the phase II L-MIND study. AACR 2023. April 14-19, 2023. Abstract CT022.