Incyte and MorphoSys Announce First Patient Dosed in Phase 3 frontMIND Study Evaluating Tafasitamab Combination as a First-Line Treatment for Diffuse Large B-Cell Lymphoma

Incyte (NASDAQ:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the first patient has been dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.

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“While more than half of DLBCL patients can be cured with an aggressive chemotherapy regimen, current outcomes for high-risk patients are poor,” said Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. “We believe we may be able to make a difference for those DLBCL patients by adding the combination of tafasitamab and lenalidomide to R-CHOP, a current standard of care.”

Each year, approximately 30,000 patients are diagnosed with DLBCL in the U.S. alone^1,2. R-CHOP is a current standard of care for patients with previously untreated DLBCL, but about 40% of patients do not respond to R-CHOP or relapse – particularly those with high-intermediate and high-risk disease³.

“Despite improvements in treatment for patients with DLBCL, there continues to be a significant medical need for additional therapies with improved outcomes,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. “We are pleased to have initiated the frontMIND study as we seek meaningful, new options for newly diagnosed, high-risk patients with DLBCL.”

In December 2020, encouraging preliminary data from firstMIND, the ongoing Phase 1b, open-label, randomized study on the safety and efficacy of R-CHOP plus either tafasitamab or tafasitamab plus lenalidomide for patients with newly diagnosed DLBCL, were presented at the American Society of Hematology (ASH) Annual Meeting. The data showed a preliminary response rate of 91.1% across both arms in a patient population that overall had a poor prognosis, and that the combination of tafasitamab, lenalidomide and R-CHOP has an acceptable tolerability profile. These results informed and supported further investigation of the tafasitamab combination in the frontMIND study.