Press release
Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®) in Relapsed or Refractory Follicular Lymphoma
- Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®) or placebo in combination with lenalidomide and rituximab met its primary
About this update from Incyte Corporation
[{"type":"text","content":"\n- Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®) or placebo in combination with lenalidomide and rituximab met its primary endpoint of progression free survival (PFS) in relapsed or refractory follicular lymphoma (FL)\n\n\n- Based on these results, Incyte expects to file a supplemental Biologics License Application for tafasitamab in combination with lenalidomide and rituximab in FL by the end of the year\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq: INCY) today announces positive topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, or placebo in combination with lenalidomide and rituximab compared to lenalidomide and rituximab alone in patients with relapsed or refractory follicular lymphoma (FL).\n\n\nThe trial met its primary endpoint of progression free survival (PFS) by investigator assessment in FL. It also met key secondary endpoints of PFS in the overall population by investigator assessment as well as the positron-emission tomography-complete response rate in the FDG-avid FL population. In addition, the secondary endpoint of PFS results by blinded independent review are consistent with investigator based PFS results. No new safety signals with tafasitamab were observed.\n\n\n“While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “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.”\n\n\nFL is the most common indolent, or slow growing, form of B-cell non-Hodgkin lymphoma (NHL) and accounts for approximately 13-26% of overall NHL cases.1,2,3,4,5 There are limited treatment options for the more than 17,000 new cases of relapsed or refractory FL treated every year in the United States, Europe and Japan.6\n\n\nBased on these positive results, Incyte expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immu...