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Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi ® (tafasitamab) by its Brazilian affiliate, United Medical Ltda. Minjuvi ® is indicated 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).
DLBCL, the most common subtype of non-Hodgkin lymphoma, presents an aggressive clinical profile. Although a significant number of patients can be cured with standard front-line therapy, many will exhibit refractory disease or relapse following an initial response and are ineligible to transplant. These patients face a very poor prognosis and need novel treatment option to improve their outcomes 1 .
According to NCCN Guidelines, Minjuvi ® is listed as one of the preferred 2 nd line treatments for DLBCL patients who are ineligible for transplantation 2 . The marketing authorization was based on the data from L-MIND study, an open label, multicenter, single arm Phase 2 trial. The primary endpoint results showed an objective response rate (ORR) of 60%, which includes a complete response rate (CR) of 43% and a disease control rate (DCR) of 75% 3 .
"The launch of Minjuvi ® brings a new treatment option to relapsed or refractory non-transplant eligible DLBCL adult patients due to its innovative characteristics and proven efficacy, with a reasonable safety profile," said Dr Guilherme Perini, hematologist specialized in Lymphomas at Hospital Israelita Albert Einstein. "Minjuvi ® will improve patients' standard of care and it is a highly anticipated therapy for our patients," added Dr Perini.
In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ: INCY), for the exclusive rights to distribute pemigatinib (Pemazyre ® ) as well as tafasitamab (sold as Monjuvi ® in the United States and Minjuvi ® in Europe) in Latin America. In July 2023, ANVISA (Agência Nacional de Vigilância Sanitária) granted Market Authorization for Minjuvi ® under the rare disease designation according to Resolution RDC 205/2017. Additionally, in October 2023, Knight received pricing approval for Minjuvi ® from the Drugs Market Regulation Chamber ("CMED").
"In line with Knight's commitment to advancing healthcare in Latin America, we are excited to launch Minjuvi in Brazil, an innovative treatment option for addressing a current unmet medical need," said Samira Sakhia, Knight Therapeutics President and CEO.
"Knight's team in Brazil is thrilled to make Minjuvi ® available to health care professionals and centers, improving DLBCL patient care in the country," said Cristiane Coelho, Knight Therapeutics Brazil General Manager.
About Tafasitamab (Minjuvi ® )
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In 2024, Incyte was assigned such license and now exclusively holds such rights. 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 transplantation (ASCT). This indication has received accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of the clinical benefit in confirmatory trial(s). Please see the U.S. full Prescribing Information for Monjuvi for important safety information.
In Europe, Minjuvi ® (tafasitamab) received conditional marketing authorization, 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 transplantation (ASCT).
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational indications have not been established in pivotal trials.
Minjuvi ® and Monjuvi ® are registered trademarks of Incyte. Tafasitamab is marketed under the brand name Monjuvi ® in the U.S. and under the brand name Minjuvi ® in Europe, the United Kingdom and Canada.
XmAb ® is a registered trademark of Xencor, Inc.
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 www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statements for Knight Therapeutics Inc.
This document may contain 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, 2022 as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information or future events, except as required by law.
References:
- Araújo, G et al. (2023). Landscape of Diffuse Large B-Cell Lymphoma (DLBCL) in Brazilian Public Healthcare System (SUS). 2023-11, ISPOR Europe 2023, Copenhagen, Denmark. Value in Health, Volume 26, Issue 11, S2 (December 2023). Available at https://www.ispor.org/docs/default-source/euro2023/postereph246131853-pdf.pdf?sfvrsn=17d37f1a_0
- National Comprehensive Cancer Network (NCCN) Guidelines. B-Cell Lymphomas dated January 18, 2024. Accessible at: Treatment by Cancer Type (nccn.org)
- Duell, J et al. (2021). Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958
CONTACT INFORMATION:
| Knight Therapeutics Inc. | ||
| Samira Sakhia | Arvind Utchanah | |
| President & Chief Executive Officer | Chief Financial Officer | |
| T: 514.484.4483 | T. +598.2626.2344 | |
| F: 514.481.4116 | ||
| Email: IR@knighttx.com | Email: IR@knighttx.com | |
| Website: www.knighttx.com | Website: www.knighttx.com |
