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 response in a subset of FL patients.
Full data from the trial will be presented at a future medical meeting.
Steven Stein“While many patients with follicular lymphoma initially benefit from first-line treatment, relapse of the disease is common, underscoring the need for additional therapies,” Incyte CMO Steven Stein said in a statement, adding that the results from the trial “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.”
Monjuvi was previously approved in combination with lenalidomide by the FDA and the EMA in 2020 and 2021 for a subset of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). Whereas DLBCL is classified as an aggressive (or fast-growing) tumor, FL and MZL are considered indolent (or slow-progressing) lymphomas.
Incyte handed over $900 million to MorphoSys in 2020 as part of a collaboration and licensing agreement to develop and commercialize Monjuvi outside the US. Then in February, Incyte bought out full global rights as Novartis acquired MorphoSys.
According to MorphoSys, the drug pulled in net product sales of $92 million in the US in 2023, with 2024 US sales expected to be between $80 million and $95 million. In the first half of this year, the drug made close to $55 million globally, according to Incyte’s financial reports.