A new recommendation supports approving the combination of tafasitamab, lenalidomide, and rituximab for adults with relapsed or refractory follicular lymphoma who have already received at least one systemic therapy. This recommendation is based on results from the phase 3 inMIND trial, which directly compared the tafasitamab triplet with the commonly used lenalidomide plus rituximab doublet.
In the study, the triplet showed a strong clinical advantage. It lowered the risk of disease progression or death by 57% and improved median progression-free survival to 22.4 months, while the doublet achieved 13.9 months. The objective response rate was also higher with the triplet—83.5% compared with 72.4%—indicating more patients experienced meaningful tumor shrinkage. Time to next treatment had not been reached for patients on the triplet, suggesting more durable disease control, whereas it was 28.8 months for the doublet. These benefits held true across multiple subgroups, including patients with refractory disease or early relapse (POD24).
The safety profile was manageable, with the most common severe side effects being neutropenia, pneumonia, and thrombocytopenia. If approval moves forward, this therapy would offer a valuable non-chemotherapy option for second-line treatment of follicular lymphoma—an approach that has been more common in later lines of therapy. The same regimen is already approved in the United States.