Incyte Announces Health Canada Approval of Minjuvi (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or…

- Minjuvi is an important new therapeutic option for eligible patients with DLBCL in Canada, addressing an urgent unmet medical need

- This marks the first marketing authorization by Health Canada for Incyte since establishing Incyte Biosciences Canada in April 2020

MONTREAL, Aug. 24, 2021 /CNW/ - Incyte (Nasdaq: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Minjuvi (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).

Incyte Biosciences Canada Logo (CNW Group/Incyte Biosciences Canada)

"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 Jose 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.

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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 Canada.

About Diffuse Large B-cell Lymphoma (DLBCL)DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide1, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease, with about 40% of patients not responding to initial therapy or relapsing thereafter2, leading to a high medical need for new, effective therapies3, especially for patients who are not eligible for an ASCT in this setting.

About L-MINDThe 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 (HCD) or autologous stem cell transplant (ASCT). The study's primary endpoint is the best objective 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.

For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.

About RE-MINDRE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

About Minjuvi (tafasitamab)Minjuvi (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 the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. The safety and efficacy of tafasitimab in other B-cell malignancies has not been established.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the United States and marketed by Incyte under the brand name Minjuvi in Canada.

XmAb is a registered trademark of Xencor, Inc.

About IncyteIncyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

To learn more about Incyte Biosciences Canada, visit https://incytebiosciences.ca.

Forward Looking StatementsExcept for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Minjuvi, in combination with lenalidomide, might provide a successful treatment option for certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the L-MIND and RE-MIND clinical trial programs generally, and whether and when the conditions from the Notice of Compliance may be removed, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2020, and the quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

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1 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:20916. doi.org/10.1016/j.beha.2018.07.014.

2 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253265. doi.org/10.3747/co.26.5421.

3 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253265. doi.org/10.3747/co.26.5421.

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Incyte Announces Health Canada Approval of Minjuvi (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or...