Incyte (Nasdaq: INCY) today reported positive results from the pivotal Phase 3 inMIND study, which evaluated the efficacy and safety of tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic CD19-targeted monoclonal antibody, in combination with lenalidomide and rituximab, versus placebo combined with lenalidomide and rituximab, in patients with relapsed or refractory follicular lymphoma (FL).
“These findings suggest that tafasitamab, when added to standard therapy, could become a valuable new treatment option for FL patients whose disease has progressed following at least one prior therapy.”
The study successfully met its primary endpoint, showing investigator-assessed progression-free survival (PFS) in FL. Additionally, the key secondary endpoints were achieved, including investigator-assessed PFS in the overall population and the complete response rate by positron emission tomography in the FDG-avid FL population. Secondary endpoint results for PFS, assessed by a blinded, independent review, were consistent with the investigator’s findings. No new safety concerns were identified with tafasitamab.
“While many patients with follicular lymphoma initially respond to first-line treatment, relapse is common, underscoring the need for additional therapies,” said Steven Stein, M.D., Chief Medical Officer at Incyte. “These results demonstrate that tafasitamab, as an adjunct to standard care, could offer a meaningful new treatment option for patients with FL who have progressed after at least one prior therapy.”
Follicular lymphoma is the most prevalent indolent or slow-growing form of B-cell non-Hodgkin lymphoma (NHL), accounting for approximately 13% to 26% of all NHL cases. Despite this, treatment options remain limited for the more than 17,000 new cases of relapsed or refractory FL treated each year in the United States, Europe, and Japan.
Following these positive outcomes, Incyte plans to submit a supplemental marketing application for tafasitamab by the end of the year for treating patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemoimmunotherapy.
The complete inMIND data will be presented at an upcoming scientific conference.
Tafasitamab, in combination with lenalidomide, was approved by the U.S. Food and Drug Administration (FDA) in 2020 and the European Medicines Agency (EMA) in 2021 for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not candidates for autologous stem cell transplantation. Tafasitamab is marketed as Monjuvi® (tafasitamab-cxix) in the United States and Minjuvi® (tafasitamab) in Europe and Canada.
About inMIND
InMIND (NCT04680052) is a global, double-blind, randomized, controlled Phase 3 trial that assessed the clinical benefit of adding tafasitamab and lenalidomide to rituximab, compared with adding lenalidomide alone to rituximab, in patients with relapsed or refractory grade 1 to 3a follicular lymphoma (FL) or relapsed or refractory nodal, splenic, or extranodal marginal zone lymphoma (MZL). The study involved 654 adults (age ≥18 years).
The primary endpoint was investigator-assessed progression-free survival (PFS) in the FL population, while key secondary endpoints included PFS in the overall population, positron emission tomography complete response (PET-CR), and overall survival (OS) in the FL population.
About Tafasitamab
Tafasitamab (Monjuvi®) is a humanized Fc-modified cytolytic CD19-targeted monoclonal antibody. In 2010, MorphoSys licensed the exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab’s Fc domain is engineered by XmAb® to mediate B-cell lysis through apoptosis and immune effector mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). MorphoSys and Incyte entered into a collaboration and license agreement in January 2020 to develop and commercialize tafasitamab worldwide, and in February 2024, Incyte was granted exclusive rights to develop and commercialize tafasitamab globally.
In the United States, Monjuvi® (tafasitamab-cxix) received accelerated FDA approval in combination with lenalidomide for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). In Europe, Minjuvi® (tafasitamab) received conditional approval from the EMA in combination with lenalidomide followed by Minjuvi monotherapy for treating adult patients with relapsed or refractory DLBCL who are not candidates for ASCT.
