Knight Therapeutics Announces Regulatory Supplemental Submission of MINJUVI® (tafasitamab) for Follicular Lymphoma in Brazil

MONTREAL, July 31, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltda., has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with rituximab and lenalidomide for the treatment of adult patients with previously treated follicular lymphoma (FL). The supplemental application for the additional indication was selected for review under Project Orbis.

In September 2021, Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (sold as MONJUVI^® in the United States and MINJUVI^® outside of the U.S.), as well as PEMAZYRE^® (pemigatinib), in Latin America.

In February 2024, Knight announced the launch of MINJUVI^® in Brazil in combination with lenalidomide followed by MINJUVI^® monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

“This regulatory submission for a new indication for tafasitamab in relapsed or refractory FL highlights our steadfast commitment to bringing innovation and enhancing quality of life and care,” said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics. “If approved, the combination of tafasitamab, rituximab and lenalidomide will be an important new therapeutic option for eligible adult patients with previously treated FL in Brazil. We look forward to continuing to work towards regulatory submissions in additional countries in Latin America over the next months.”

About Follicular Lymphoma (FL) and inMIND Study

FL is the most common indolent, or slow growing, form of non-Hodgkin lymphoma (NHL).¹  In Brazil, according to the 2023 data from the National Cancer Institute (INCA) Registries, the expected incidence/year of NHL (inclusive of all subtypes) was 5.57 per 100, 000 in the general population, 6.42 per 100,000 in the male population, and 5.62 per 100,000 in the female population. It is expected that follicular lymphoma constitutes 20% to 25% of adult NHL cases.^2,3,4 There are limited treatment options for relapsed or refractory FL.⁵

The submission is based on the results from the pivotal Phase 3 inMIND trial, a double-blind, placebo-controlled trial randomizing 548 patients with relapsed or refractory FL to receive tafasitamab or placebo with lenalidomide and rituximab. Key results from the trial demonstrated that tafasitamab plus lenalidomide and rituximab significantly improved progression-free survival (PFS) in patients with relapsed or refractory FL compared to a placebo. The median PFS was 22.4 months in the treatment arm versus 13.9 months in the placebo arm, representing a 57% reduction in the risk of disease progression, relapse, or death. Secondary endpoints also showed improvements, with higher response rates and longer durations of response observed in the treatment arm.⁶

About MINJUVI^® (tafasitamab)

MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. 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). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., MONJUVI® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

MONJUVI® is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, MONJUVI® received accelerated approval in the United States 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, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, MINJUVI® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVI® monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

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

MONJUVI, MINJUVI, the MINJUVI and MONJUVI logos and the “triangle” design are registered trademarks of Incyte.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at or .

Forward-Looking Statements

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2024, as filed on . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

References:

1. Kaseb H, et al. Follicular Lymphoma. Treasure Island (FL): StatPearls Publishing; 2025 Jan.
2. Kanters S, et al. BMC Cancer. 2023;23:74.
3. Smith SM, Salles G. Haematologica. 2022;107:4-6.
4. Swerdlow SH, Campo E, Pileri SA, et al. Blood. 2016;127:2375-2390.
5. Decision Resources Group. Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia, Landscape & Forecast. 2020.
6. Sehn L H., et al. ASH Annual Meeting 2024; Late Breaking Abstract Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND).