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In a phase III trial (inMIND) reported in The Lancet, Sehn et al found that the addition of the CD19-targeted Fc-enhanced monoclonal antibody tafasitamab to lenalidomide plus rituximab improved progression-free survival in patients with relapsed or refractory follicular lymphoma.

Study Details

In the global double-blind trial, 548 patients from sites in North America, Europe, and the Asia-Pacific region were randomly assigned between April 2021 and August 2023 to receive up to twelve 28-day cycles of tafasitamab at 12 mg/kg on days 1, 8, 15, and 22 of cycles 1 to 3 and days 1 and 15 of cycles 4 to 12 (n = 273) or placebo (n = 275), with both groups receiving lenalidomide at 20 mg/day on days 1 to 21 of cycles 1 to 12 and rituximab at 375 mg/m² on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2 to 5. In total, 80% of patients were White. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population.

Key Findings

Median follow-up was 14.3 months (95% confidence interval [CI] = 11.8–15.0 months) in the tafasitamab group and 14.1 months (95% CI = 11.5–15.0 months) in the control group. Median progression-free survival on investigator assessment was 22.4 months (95% CI = 19.2 months to not evaluable) in the tafasitamab group vs 13.9 months (95% CI = 11.5–16.4 months) in the control group (hazard ratio [HR] = 0.43, 95% CI = 0.32–0.58, P < .0001).

On independent review committee assessment, median progression-free survival was not reached (95% CI = 19.3 months to not evaluable) in the tafasitamab group vs 16.0 months (95% CI = 13.9–21.1 months) in the control group (HR = 0.41, 95% CI = 0.29–0.56, P < .0001).

Death occurred in 15 patients in the tafasitamab group and 23 patients in the control group. Full analysis of overall survival is planned at 5 years of follow-up.

Grade 3 to 4 adverse events occurred in 71% of the tafasitamab group vs 69% of the control group. The most common were neutropenia (40%), pneumonia (8%), COVID-19 (6%), and thrombocytopenia (6%) in the tafasitamab group, and neutropenia (38%), thrombocytopenia (7%), anemia (6%), and pneumonia (5%) in the control group. Serious adverse events occurred in 36% vs 32% of patients, most commonly pneumonia in both groups (8% vs 5%). Adverse events led to the discontinuation of treatment in 11% vs 7% of patients.

The investigators concluded: “The addition of tafasitamab to lenalidomide and rituximab resulted in a statistically significant and clinically meaningful improvement in progression-free survival, with an acceptable safety profile in patients with relapsed or refractory follicular lymphoma. This combination represents a potential new standard-of-care treatment.”

Laurie H. Sehn, MD, of BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, Canada, is the corresponding author for The Lancet article.

Disclosure: The study was funded by Incyte. For full disclosures of the study authors, visit thelancet.com.