Incyte will go to the FDA by the end of the year with a supplemental BLA for its cancer drug Monjuvi after it hit all the endpoints in a Phase 3 study in follicular lymphoma.
The Phase 3 inMIND trial enrolled 654 patients with relapsed or refractory follicular lymphoma and relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma. The patients received either Monjuvi and lenalidomide as an add-on to rituximab, or lenalidomide alone as an add-on to rituximab.
Notably, the primary endpoint only tracked progression-free survival among patients who had follicular lymphoma, where there were “previous, exploratory data” when the trial began in 2021.
Incyte announced Thursday that the trial met that primary endpoint, and also hit the secondary endpoints: progression-free survival in the overall trial population, covering both follicular lymphoma (FL) and marginal zone lymphoma (MZL); overall survival in the FL group; and positron emission tomography complete
