Knight Therapeutics Announces Approval of Minjuvi® (tafasitamab) in Mexico
15 Oktober 2024 - 2:30PM
Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American
(ex-USA) specialty pharmaceutical company, announced today that its
Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V.
has obtained regulatory approval by COFEPRIS, the Mexican health
regulatory agency, for Minjuvi® (tafasitamab) 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).
DLBCL is the most common subtype of non-Hodgkin
lymphoma, presenting an aggressive clinical profile. While a
significant number of patients can be cured with standard
front-line therapy, many will develop refractory disease or relapse
following an initial response, and these individuals are often
ineligible for ASCT. Such patients face a very poor prognosis,
emphasizing the need for treatment options to improve their
outcomes1.
The approval is based on the data from L-MIND
trial, an open label, multicenter, single arm Phase 2 study, that
evaluated Minjuvi® in combination with lenalidomide for the
treatment of adult patients with relapsed or refractory DLBCL
ineligible for ASCT. The study primary analysis results
demonstrated an objective response rate (ORR, primary endpoint) of
60%, including a complete response rate (CR) of 43% and a disease
control rate (DCR) of 74%3. According to the 2024 National
Comprehensive Cancer Network (NCCN) Guidelines, Minjuvi® is
listed as one of the preferred second-line treatments for DLBCL
patients who are ineligible for transplantation2.
“Minjuvi® has a unique and innovative mechanism
of action targeting CD19 and represents a significant advancement
in the treatment of DLBCL. It is a chemo-free targeted
immunotherapy which offers sustained remission for non-transplant
eligible adult patients who have relapsed or are refractory to at
least one previous line of treatment. I am enthusiastic about the
transformative potential of Minjuvi® in improving patient
outcomes,” said Dr. Adrian Alejandro Ceballos, internist and
hematologist at CENIT Medical Center in Merida, Mexico.
“We are thrilled to announce the approval of
Minjuvi®, in Mexico, an innovative treatment for adult patients
with relapsed or refractory DLBCL. With its novel mechanism of
action, Minjuvi® offers a new treatment alternative to
non-transplant eligible patients who have limited treatment
options. This approval, with launch expected in the first half of
2025, marks an important step in our mission to bring life-changing
therapies to the Mexican market and improve the lives of patients
facing this challenging condition,” said Samira Sakhia, President
and CEO of Knight.
In September 2021, Knight entered into a supply
and distribution agreement with Incyte (NASDAQ: INCY), for the
exclusive rights to distribute tafasitamab (sold as Monjuvi® in the
United States and Minjuvi® in Europe) in Latin America.
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). MorphoSys
and Incyte entered into: (a) in January 2020, a
collaboration and licensing agreement to develop and commercialize
tafasitamab globally; and (b) in February 2024, an agreement
whereby Incyte obtained exclusive rights to develop and
commercialize tafasitamab globally.
In the United States,
Monjuvi® (tafasitamab-cxix) received accelerated approval
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 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
www.knighttx.com or www.sedarplus.ca.
Forward-Looking Statements for
Knight
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, 2023, as filed on www.sedarplus.ca. 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:
- Duarte C, Kamdar M. Management
Considerations for Patients With Primary Refractory and Early
Relapsed Diffuse Large B-Cell Lymphoma. Am Soc Clin Oncol Educ
Book. 2023 Jan;43:e390802
- 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. 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 FOR KNIGHT:
Investor Contact: |
|
|
Knight Therapeutics Inc. |
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|
Samira Sakhia |
|
Arvind Utchanah |
President & Chief Executive
Officer |
|
Chief Financial Officer |
T: 514.484.4483 |
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T. +598.2626.2344 |
F: 514.481.4116 |
|
|
Email: IR@knighttx.com |
|
Email: IR@knighttx.com |
Website: www.knighttx.com |
|
Website: www.knighttx.com |
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