Tafasitamab-cxix plus lenalidomide followed by tafasitamab-cxix monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to five-year follow-up data from the phase II L-MIND study.1
The results of the open-label, single-arm, multicenter study led by Johannes Duell, MD, were presented at the at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida.
At the data cut-off (November 14, 2022) for the full analysis set of 80 patients, the overall response rate (ORR) was 57.5% (95% CI, 45.9-68.5), and a complete response (CR) was observed in 41.2% of patients (95% CI, 30.4-51.6; n=33). A partial response (PR) was observed in 16.2% of patients (95% CI, 8.9-26.2; n=13).
The median duration of response was not reached after a median follow up of 44 months (95% CI, 29.9-57.0). The median overall survival (OS) was 33.5 months (95% CI, 18.3-not reached), and median progression-free survival was 11.6 months (95% CI, 5.7-45.7).
Of the 21 patients with >60 months of follow-up, 14 received one prior line of therapy, and seven patients received at least two prior lines of therapy. Patients with one prior line of therapy (n=40) had a higher ORR of 67.5% (CR=52.5%; PR=15%) compared with an ORR of 47.5% in patients with two or more prior lines of therapy (CR=30%; PR=17.5%; n=40).
No new safety signals were identified. The majority of adverse events were grade 1 or 2 during both combination and monotherapy treatment. Patients experienced a lower frequency of all-grade and grade 3 or higher adverse events during monotherapy.
The most common adverse events with combination therapy were neutropenia (incidence per person per year, all-grade/grade ≥3: 3.79/2.09) and thrombocytopenia (1.52/0.52), which declined after patients switched to monotherapy (all-grade/grade ≥3: 1.09/0.70 and 0.17/0.06, respectively, in the first two years of monotherapy). Neutropenia and diarrhea were the most common adverse events in the first two years of monotherapy.
“These five-year data from L-MIND provide further validation of the durability of the responses and meaningful OS with this immunotherapy combination, along with a low incidence of adverse events in the monotherapy and follow-up phases of the study,” Nagesh Kalakonda, PhD, noted during the presentation at AACR.2
References
1. MorphoSys and Incyte Announce Five-Year Results of L-MIND Study Showed Prolonged, Durable Responses in Relapsed or Refractory DLBCL Patients Treated with Monjuvi® (tafasitamab-cxix). MorphoSys and Incyte. March 16, 2023. Accessed March 16, 2023. MorphoSys and Incyte Announce Five-Year Results of L-MIND Study Showed Prolonged, Durable Responses in Relapsed or Refractory DLBCL Patients Treated with Monjuvi® (tafasitamab-cxix
2. Duell J, Abrisqueta A, Andre M, et al. Five-Year safety and efficacy of tafasitamab in patients with relapsed or refractory DLBCL: final results from the phase 2 L-MIND study. Presented at the American Association of Cancer Research; April 14-19, 2023; Orlando, Florida.
