Quebec Becomes the First Province to Reimburse Minjuvi® (Tafasitamab) in Combination with Lenalidomide for Patients with Diffuse Large B-Cell Lymphoma

Minjuvi^® (tafasitamab) is the first CD19 targeted immunotherapy option for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), addressing a significant unmet medical need

This is the first public listing since Minjuvi was approved with conditions by Health Canada in August 2021

MONTREAL, Aug. 17, 2023 /CNW/ - Incyte Biosciences Canada is pleased to announce that Quebec has made Minjuvi^® (tafasitamab) in combination with lenalidomide accessible with reimbursement under the Régie de l'assurance maladie du Québec (RAMQ) for eligible patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This first listing follows a positive clinical recommendation by the health technology assessment agency Institut national d'excellence en santé et en services sociaux (INESSS)ⁱ in December 2022.

In Canada, health technology assessment (HTA) recommendations are an important milestone towards public funding of new medicines as they reinforce the therapeutic value and the need for new approaches. Following the INESSS positive HTA recommendation, the pan-Canadian Pharmaceutical Alliance (pCPA) entered into active negotiations, which concluded with a letter of intent.ⁱⁱ The pCPA is an alliance of provincial, territorial and federal governments that collaborates on a range of public drug plan initiatives to increase and manage access to clinically effective and affordable drug treatments.

"The RAMQ public listing is welcome news for the lymphoma community across Quebec," says Dr. Christopher Lemieux, Hematologist-Oncologist at CHU de Québec-Université Laval. "Minjuvi in combination with lenalidomide is a new targeted immunotherapy option that can offer a chance of long-term remission for patients who are not eligible for autologous stem cell transplantation (ASCT). Effective, accessible options are limited for these patients today, so I hope more provinces will follow Quebec's lead."

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwideⁱⁱⁱ, 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 thereafter^iv, leading to a high medical need for new, effective therapies^v especially for patients who are not eligible for an ASCT in this setting. The incidence rates of DLBCL in Canada increased steadily during 1992-2010 with an average incidence rate of 34.18 cases per million individuals per year^vi. 

"We commend the Government of Quebec for their leadership in making Minjuvi in combination with lenalidomide accessible," says Christine Lennon, General Manager, Incyte Biosciences Canada. "The RAMQ listing is a step in the right direction, and we will continue to work diligently with all regulatory authorities ? including Cancer Agencies across Canada ? so that any patient in Canada who may benefit from this treatment can have access to it."

Commencing today, Minjuvi in combination with lenalidomide, approved by Health Canada in August 2021, is on the Liste des médicaments des établissements de la Régie de l'assurance maladie du Québec (RAMQ)^vii for the treatment of adult patients with relapsed or refractory DLBCL unless qualified, including DLBCL resulting from low-grade lymphoma, who are not eligible for an autologous stem cell transplantation. In addition, patients must meet the following criteria 1) no previous anti-CD19 therapy; and 2) ECOG performance status of 0 to 2.

"Today's announcement of this new treatment option is great news for relapsed/refractory DLBCL patients in Quebec," says Antonella Rizza, Chief Executive Officer of Lymphoma Canada. "It is our hope that equitable access to this therapy be a priority across all provinces so that patients living with this aggressive subtype of lymphoma have more available treatment options." Lymphoma Canada is the country's only national charity devoted solely to lymphoma and the empowerment of patients and the lymphoma community through education, support, advocacy and research. https://www.lymphoma.ca/ 

Minjuvi^® (tafasitamab) is a humanized Fc-modified CD19 targeting immunotherapy. 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).

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

Monjuvi^® and Minjuvi^® 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 Europe and Canada.

XmAb^® is a registered trademark of Xencor, Inc.

Incyte 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 Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding Incyte's expectations relating to the use of Minjuvi for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Incyte's expectations regarding reimbursement for and access to Minjuvi, and Incyte's ongoing clinical development program for tafasitamab, contain predictions, estimates, and other forward-looking statements.

These forward-looking statements are based on Incyte'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 and the ability to enroll subjects in accordance with planned schedules; determinations made by Health Canada and other regulatory authorities; Incyte's dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte's products and the products of its collaboration partners; the acceptance of Incyte's products and the products of its 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 U.S. Securities and Exchange Commission, including its annual report for the year ended December 31, 2022 and subsequent quarterly updates.. The Company disclaims any intent or obligation to update these forward-looking statements.

SOURCE Incyte Biosciences Canada