Tafasitamab Shows Promising Results in Follicular Lymphoma Phase 3 Trial

Incyte’s tafasitamab (Monjuvi) increased progression-free survival in refractory or relapsed follicular lymphoma patients by 22.4 months, when compared with placebo, which increased survival by 13.9 months, according to additional results from the phase 3 inMIND trial published in a news release. Patients treated with tafasitamab also showed a 57% reduction in risk of progression, relapse or death when compared with placebo. This is the first study to examine the effectiveness of combining two antibodies to treat follicular lymphoma. Results were presented at the 2024 American Society of Hematology held in San Diego.

Tafasitamab is on track to gain FDA approval by the second half of 2025, according to an Incyte investor call.

The study included 548 patients with relapsed or refractory follicular lymphoma. Patients received either a combination of tafasitamab - a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody—along with the blood cancer drug lenalidomide and the antibody rituximab, or they received rituximab and lenalidomide alone.

Large B-cell follicular lymphoma is the most common type of B-cell non-Hodgkin lymphoma, diagnosed in more than 25,000 patients annually in the United States. It is slow-growing cancer that affects the lymph nodes, characterized by swollen lymph nodes, night sweats and unexplained weight loss. This type of lymphoma is incurable, and patients with relapse or refractory diffuse large B-cell lymphoma have a five-year survival rate of 50%, according to research published in the National Library of Medicine. The average age of diagnosis is 60.

“Patients with follicular lymphoma have a high risk of relapse, yet there are limited treatment options in the relapsed and refractory setting,” Laurie Sehn, M.D., M.P.H., from the British Columbia Cancer Centre for Lymphoid Cancer said in the news release. “The goal of therapy is primarily to prolong remission, while maintaining quality of life. The inMIND trial demonstrated a meaningful improvement in disease control with the addition of the anti-CD19 monoclonal antibody tafasitamab to lenalidomide and rituximab, providing patients with a new, well tolerated, immunotherapy combination.”

The most common adverse effects were neutropenia (48.5%), diarrhea (37.6%) and COVID-19 (31.4%).

The Department of Veterans Affairs added Monjuvi to its national formulary in November 2024.