Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial

A phase 3, double-blind, randomised, placebo-controlled trial at 210 centres in North America, Europe and the Asia-Pacific region. Adults with relapsed or refractory follicular lymphoma after at least one previous line were randomised 1 to 1 to up to twelve 28-day cycles of tafasitamab 12 mg per kilogram intravenously, or placebo, both with lenalidomide 20 mg daily on days 1 to 21 of cycles 1 to 12 and rituximab 375 mg per square metre. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population.

Between 16 April 2021 and 10 August 2023, 548 of 817 patients assessed were enrolled and randomised, 273 to tafasitamab and 275 to placebo; 299 (55 per cent) were male and 249 (45 per cent) female. Median progression-free survival by investigator was 22.4 months (95 per cent confidence interval 19.2 to not evaluable) with tafasitamab against 13.9 months (11.5 to 16.4) with placebo, a hazard ratio of 0.43 (0.32 to 0.58).