Incyte Seeks Expanded FDA Approval For Lymphoma Drug After Releasing Promising Topline Data From Late-Stage Study

On Friday, Incyte Corporation INCY released topline results from the pivotal Phase 3 inMIND trial evaluating the efficacy and safety of Monjuvi (tafasitamab) and lenalidomide as an add-on to rituximab compared with lenalidomide alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL).

The study enrolled 654 adults.

The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment in follicular lymphoma.

Also Read: FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication.

It also met key secondary endpoints of PFS in the overall population by investigator assessment and the positron-emission tomography-complete response rate in the FDG-avid FL population.

In addition, the secondary endpoint of PFS results by the blinded independent review is consistent with investigator-based PFS results.

No new safety signals with tafasitamab were observed.

Follicular lymphoma is the most common indolent, or slow-growing, form of B-cell non-Hodgkin lymphoma (NHL), accounting for approximately 13-26% of overall NHL cases.

There are limited treatment options for the more than 17,000 new cases of relapsed or refractory Follicular lymphoma treated every year in the United States, Europe, and Japan.

Incyte expects to file a supplemental marketing application for tafasitamab by the end of the year for follicular lymphoma patients who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy.

The FDA and the European Medicines Agency approved tafasitamab in combination with lenalidomide in 2020 and 2021, respectively, for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for autologous stem cell transplant.

Incyte reported second quarter Minjuvi/ Monjuvi sales of $31.12 million, up 136% year over year, following the acquisition of the exclusive global rights to tafasitamab in February 2024.

Price Action: INCY stock is up 1.82% at $62.80 during the premarket session at last check Friday.

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