inMIND: Tafasitamab + lenalidomide + rituximab for R/R FL

Results from the international, phase III, randomized, placebo-controlled inMIND trial (NCT04680052) evaluating tafasitamab in combination with lenalidomide + rituximab vs placebo + lenalidomide + rituximab in 548 patients with relapsed or refractory (R/R) follicular lymphoma (FL) were recently published in The Lancet by Sehn et al. The primary endpoint was progression-free survival (PFS) and key secondary endpoints included positron emission tomography-complete response (PET-CR) rate in the fluorodeoxyglucose (FDG)-avid population (defined as the proportion of patients achieving a complete metabolic response at any time after the start of treatment among patients with a positive baseline PET scan) and overall survival (OS). 

Key data: The addition of tafasitamab to lenalidomide + rituximab resulted in longer median PFS vs placebo (22.4 months vs 13.9 months; hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.32–0.58; p < 0.0001). Among patients with FDG-avid disease at baseline (tafasitamab + lenalidomide + rituximab, n = 251; placebo + lenalidomide + rituximab, n = 254), the PET-CR rate was higher with tafasitamab than with placebo (49% vs 40%; odds ratio [OR], 1.5; 95% CI, 1.04–2.13; p = 0.029). In the intention-to-treat population, the best overall response rate (ORR) was improved with tafasitamab vs placebo (84% vs 72%; OR, 2.0; 95% CI, 1.30–3.02; p = 0.0014). A full analysis of OS is planned at 5 years of follow-up. The incidence of adverse events (AEs) was similar between groups and aligned with expectations for the patient population. 

Key learning: Tafasitamab combined with lenalidomide + rituximab demonstrated statistically significant and clinically meaningful improvement in PFS with manageable toxicity in patients with R/R FL, representing a potential new standard-of-care treatment option.