Tafasitamab, an Fc-modified, humanized, anti-CD19 monoclonal antibody, combined with the immunomodulatory drug Lenalidomide ( Revlimid ), was clinically active with a good tolerability profile in the open-label, single-arm, phase II L-MIND study of autologous stem-cell transplant (ASCT)-ineligible patients with relapsed / refractory ( R/R ) diffuse large B-cell lymphoma ( DLBCL ).
To assess long-term outcomes, researchers have reported an updated analysis with greater than or equal to 35 months' follow-up.
Patients were aged more than 18 years, had 1-3 prior systemic therapies ( including 1 or more CD20-targeting regimen ) and ECOG performance status 0-2.
Patients received 28-day cycles of Tafasitamab ( 12 mg/kg intravenously ), once weekly during cycles 1-3, then every 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.
The primary endpoint was best objective response rate ( ORR ).
After greater than or equal to 35 months' follow-up ( data cut-off: October 30, 2020 ), objective response rate was 57.5% ( n=46/80 ), including a complete response in 40.0% of patients ( n=32/80 ) and a partial response in 17.5% of patients ( n=14/80 ).
Median duration of response ( DoR ) was 43.9 months ( 95% CI: 26.1-not reached [ NR ] ); median overall survival ( OS ) was 33.5 months ( 18.3-NR ); and median progression-free survival was 11.6 months ( 6.3-45.7 ).
There were no unexpected toxicities. Subgroup analyses revealed consistent long-term efficacy results across most patient subgroups.
This extended L-MIND follow-up has confirmed the long duration of response, meaningful overall survival, and welldefined safety profile of Tafasitamab plus Lenalidomide followed by Tafasitamab monotherapy in ASCT-ineligible patients with relapsed / refractory diffuse large B-cell lymphoma. ( Xagena )
Johannes Duell et al, Haematologica 2021; Online ahead of print