Add-on tafasitamab prolongs PFS in relapsed, refractory follicular lymphoma

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Add-on tafasitamab prolongs PFS in relapsed, refractory follicular lymphoma

In the treatment of patients with relapsed or refractory follicular lymphoma, adding tafasitamab to lenalidomide and rituximab appears to improve progression-free survival (PFS) while having an acceptable safety profile, according to the phase III inMIND study.

The study included 548 patients (55 percent male) with relapsed or refractory follicular lymphoma who had received at least one previous line of systemic therapy. These patients were randomly assigned to receive treatment with up to 12 cycles (28-day cycle length) of tafasitamab (12 mg/kg by intravenous infusion on days 1, 8, 15, and 22 of cycles 1–3 and days 1 and 15 of cycles 4–12) or placebo, both added to lenalidomide (20 mg/day orally on days 1–21 of cycles 1–12) and rituximab (375 mg/m2 by intravenous infusion on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2–5).

A total of 273 patients were included in the tafasitamab group and 275 in the placebo group. The primary endpoint of PFS was significantly longer in the tafasitamab vs placebo group (median, 22.4 vs 13.9 months; p<0.0001). 

Adverse events (AEs) occurred in 99 percent of patients each in the tafasitamab group and the placebo group. The most common AEs were neutropenia (49 percent vs 45 percent, respectively) and diarrhoea (38 percent vs 28 percent). Treatment-related AEs leading to death occurred in two patients in the placebo group and none in the tafasitamab group.

The findings point to the potential of the tafasitamab plus lenalidomide and rituximab as a new standard-of-care treatment in relapsed or refractory follicular lymphoma.

Lancet 2026;407:133-146