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 outcomes1.
According to NCCN Guidelines, Minjuvi® is listed
as one of the preferred 2nd line treatments for DLBCL patients who
are ineligible for transplantation2. 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. |
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Samira Sakhia |
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Arvind Utchanah |
President & Chief Executive Officer |
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Chief Financial Officer |
T: 514.484.4483 |
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T. +598.2626.2344 |
F: 514.481.4116 |
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Email: IR@knighttx.com |
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Email: IR@knighttx.com |
Website: www.knighttx.com |
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Website: www.knighttx.com |
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