Benzinga | Aug 24, 2021 08:36AM EDT

Incyte Announces Health Canada Approval Of Minjuvi (tafasitamab) In Combination With Lenalidomide For Treatment Of Adults With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

Incyte (NASDAQ:INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Minjuvi(r) (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide for the treatment of 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 (ASCT).

"The data from L-MIND demonstrated that eligible patients treated with tafasitamab and lenalidomide had a high likelihood of benefit, which was durable in many cases," said Dr. Laurie Sehn, Clinical Professor with BC Cancer Centre for Lymphoid Cancer and The University of British Columbia. "It is encouraging to see new treatments become available for patients with relapsed or refractory DLBCL, especially given the historical lack of options for them."

"The approval of Minjuvi is the first marketing authorization for Incyte in Canada and brings an innovative targeted therapeutic option to the Canadian clinical community to treat their patients with relapsed or refractory DLBCL," said Jos?e Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. "DLBCL is the most common form of non-Hodgkin lymphoma in adults, and Incyte is committed to working to provide access to Minjuvi for the patients in Canada who need it most."

The conditional approval is based on data from the L-MIND study, an open label, multicentre single arm 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 ASCT, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. Removal of the conditions from the Notice of Compliance is contingent upon verification and description of clinical benefit in a confirmatory trial(s). The results from L-MIND showed an overall response rate (ORR) of 53.5% (primary endpoint), including a complete response (CR) rate of 35.2% and a partial response rate (PR) of 18.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 34.6 months (secondary endpoint). Adverse events (AEs) reported included infusion-related reactions, serious or severe myelosuppression, including neutropenia, thrombocytopenia, anemia, infections and tumour lysis syndrome.

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 Canada.