Incyte reported promising topline results from the Phase 3 inMIND trial that assessed the efficacy and safety of tafasitamab (Monjuvi) in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL).
Tafasitamab is a humanised Fc-modified, cytolytic CD19-targeting monoclonal antibody.
The global, double-blind, randomised, controlled inMIND trial evaluated Monjuvi in combination with lenalidomide and rituximab against lenalidomide and rituximab alone.
The trial successfully achieved its primary endpoint of progression-free survival (PFS) as assessed by investigators in FL.
It also met several key secondary endpoints, including PFS in the overall population and the positron-emission tomography-complete response rate in the FDG-avid FL cohort.
Additionally, PFS results from blinded independent review were consistent with those from investigator assessments. No new safety concerns with tafasitamab were identified.
Incyte chief medical officer Steven Stein said: “While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies.
“These results demonstrate the potential of tafasitamab added to the standard of care to be a meaningful new treatment option for patients with FL whose disease has progressed after at least one prior therapy.”
Incyte plans to submit a supplemental biologics licence application (sBLA) for tafasitamab by the end of the year based on these findings.
The application will seek approval for treating patients with FL who have experienced failure with at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy.
Tafasitamab, in combination with lenalidomide, was approved by the US 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).
It is marketed as Monjuvi (tafasitamab-cxix) in the US and Minjuvi in Europe and Canada.
In 2010, MorphoSys obtained exclusive worldwide rights from Xencor to develop and commercialise tafasitamab.
In January 2020, MorphoSys and Incyte signed an agreement to jointly develop and commercialise the drug globally. Then, in February 2024, Incyte gained exclusive global rights to tafasitamab.
