Benzinga | Aug 26, 2021 04:02PM EDT

MorphoSys And Incyte Announce European Commission Approval Of Minjuvi In Combination With Lenalidomide For Treatment Of Adults With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

MorphoSys AG ((FSE:MOR, NASDAQ:MOR) and Incyte (INCY) today announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi(r) (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). The EC Decision follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending the conditional marketing authorization of Minjuvi.

"People living with relapsed or refractory DLBCL in the EU have historically had limited treatment options and a poor prognosis. However, with the EC's approval of Minjuvi, eligible patients now have a new and much needed treatment option," said Herv? Hoppenot, Chief Executive Officer, Incyte. "We will now focus our efforts on working with individual countries in Europe to provide people access to this new treatment."

"The approval of Minjuvi is a crucial milestone for patients with relapsed or refractory DLBCL in Europe, "said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. "DLBCL is the most common type of non-Hodgkin lymphoma in adults and Minjuvi addresses an urgent unmet medical need for the 30-40% of people who do not respond to or relapse after initial therapy."

The conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Tafasitamab together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable. Warnings and precautions for tafasitamab include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.

"The data from the L-MIND study demonstrate the potential benefits, including long duration of response, that tafasitamab may have for eligible DLBCL patients," said Professor Pier Luigi Zinzani M.D., Ph.D., Head of Lymphoma Group at University of Bologna. "It is encouraging to see new treatments become available for these patients, especially given the historical lack of treatment options in this area."

Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(r) in the U.S., and is marketed by Incyte under the brand name Minjuvi(r) in the EU.