Incyte Reports Positive Results from Key Tafasitamab Study in Relapsed/Refractory Follicular Lymphoma

Incyte has announced promising results from its pivotal Phase 3 inMIND trial, which assessed the efficacy and safety of tafasitamab (Monjuvi®) in combination with lenalidomide and rituximab versus a placebo combined with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL). This study is significant as follicular lymphoma is the most prevalent slow-growing form of B-cell non-Hodgkin lymphoma and represents a significant subset of non-Hodgkin lymphoma cases, with limited treatment options for relapse cases.

The trial achieved its primary endpoint, showing a notable improvement in progression-free survival (PFS) as evaluated by investigators. Secondary endpoints were also met, including PFS in the overall population and positron-emission tomography-complete response rates in the FDG-avid FL population. Furthermore, the results from the blinded independent review echoed the investigator-assessed PFS outcomes. Importantly, no new safety concerns emerged with the use of tafasitamab.

Dr. Steven Stein, Chief Medical Officer at Incyte, emphasized the necessity for new therapeutic options for FL patients who frequently experience relapse post-initial treatment. He highlighted that the trial's results underline the potential of tafasitamab in combination with the existing standard of care as a valuable treatment alternative for these patients.

Based on these encouraging findings, Incyte plans to submit a supplemental Biologics License Application by the end of the year to seek approval for the use of tafasitamab in combination with lenalidomide and rituximab for patients with FL who have previously undergone at least one systemic anti-CD20 immunotherapy or chemo-immunotherapy. Additionally, comprehensive data from the inMIND trial will be presented at an upcoming scientific conference.

Tafasitamab was previously approved in the United States and Europe, in combination with lenalidomide, for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are ineligible for autologous stem cell transplantation. In the U.S., it is marketed as Monjuvi® (tafasitamab-cxix) and in Europe and Canada as Minjuvi® (tafasitamab).

The inMIND study is a global, double-blind, randomized, controlled Phase 3 trial that enrolled 654 adults with relapsed or refractory FL Grades 1 to 3a, or relapsed/refractory nodal, splenic, or extranodal marginal zone lymphoma (MZL). The study's primary endpoint focused on PFS by investigator assessment in the FL population, with secondary endpoints including PFS in the overall population, positron emission tomography complete response (PET-CR), and overall survival (OS) in the FL population.

Tafasitamab is a humanized Fc-modified monoclonal antibody targeting CD19, developed under a licensing agreement between MorphoSys and Xencor, with Incyte holding exclusive global development and commercialization rights since February 2024. The antibody functions by mediating B-cell lysis through apoptosis and immune effector mechanisms, including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

Incyte, headquartered in Wilmington, Delaware, is a global biopharmaceutical company dedicated to discovering and developing innovative treatments for patients with unmet medical needs. The company has a robust portfolio of proprietary therapeutics in oncology, inflammation, and autoimmunity, with operations extending across North America, Europe, and Asia.