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- 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)
- 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
Incyte (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).
The 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.
Posted In: INCY
