Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi? (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 Hervé 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 Minjuvi 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). Minjuvi together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable. Warnings and precautions for Minjuvi 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 the 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? in the U.S., and is marketed by Incyte under the brand name Minjuvi? in the EU.

About Diffuse Large B-Cell Lymphoma 

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases4, and is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs5. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter6. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL7,8,9.

About L-MIND 

The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplant (ASCT). The study's primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

About Minjuvi? (tafasitamab) 

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb?engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi?(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi? (tafasitamab) received conditional approval, 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).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi? and Monjuvi? are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi? in the U.S., and marketed by Incyte under the brand name Minjuvi? in the EU.

XmAb? is a registered trademark of Xencor, Inc.