- Minjuvi is an important new therapeutic
option for eligible patients with DLBCL in Canada, addressing an urgent unmet medical
need
- This marks the first marketing authorization
by Health Canada for Incyte since establishing Incyte Biosciences
Canada in April 2020
MONTREAL, Aug. 24, 2021 /CNW/ - Incyte (Nasdaq: INCY)
today announced that Health Canada has granted a Notice of
Compliance with conditions for Minjuvi® (tafasitamab), a
humanized Fc-modified cytolytic CD19 targeting monoclonal antibody,
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, who are not eligible for autologous stem cell
transplant (ASCT).
"The data from L-MIND demonstrated that eligible patients
treated with tafasitamab and lenalidomide had a high likelihood of
benefit, which was durable in many cases," said Dr. Laurie Sehn, Clinical Professor with BC Cancer
Centre for Lymphoid Cancer and The University
of British Columbia. "It is encouraging to see new
treatments become available for patients with relapsed or
refractory DLBCL, especially given the historical lack of options
for them."
"The approval of Minjuvi is the first marketing authorization
for Incyte in Canada and brings an
innovative targeted therapeutic option to the Canadian clinical
community to treat their patients with relapsed or refractory
DLBCL," said Josée Brisebois, Ph.D., Head of Medical Affairs,
Incyte Biosciences Canada. "DLBCL is the most common form of
non-Hodgkin lymphoma in adults, and Incyte is committed to working
to provide access to Minjuvi for the patients in Canada who need it most."
The conditional approval is based on data from the L-MIND study,
an open label, multicentre single arm study evaluating the safety
and efficacy of Minjuvi in combination with lenalidomide as a
treatment for patients with relapsed or refractory DLBCL who are
not eligible for ASCT, and is supported by the RE-MIND study, an
observational retrospective study in relapsed or refractory DLBCL.
Removal of the conditions from the Notice of Compliance is
contingent upon verification and description of clinical benefit in
a confirmatory trial(s). The results from L-MIND showed an overall
response rate (ORR) of 53.5% (primary endpoint), including a
complete response (CR) rate of 35.2% and a partial response rate
(PR) of 18.3%, as assessed by an independent review committee. The
median duration of response (mDOR) was 34.6 months (secondary
endpoint). Adverse events (AEs) reported included infusion-related
reactions, serious or severe myelosuppression, including
neutropenia, thrombocytopenia, anemia, infections and tumour lysis
syndrome.
Incyte and MorphoSys share global development rights to
tafasitamab; Incyte has exclusive commercialization rights to
tafasitamab outside the United
States. Tafasitamab is co-marketed by Incyte and MorphoSys
under the brand name Monjuvi® in the U.S. and is
marketed by Incyte under the brand name Minjuvi® in
Canada.
About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is
the most common type of non-Hodgkin lymphoma in adults
worldwide1, 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 thereafter2, leading to a
high medical need for new, effective
therapies3, especially for patients who are
not eligible for an ASCT in this setting.
About L-MIND
The L-MIND trial is a single arm,
open-label Phase 2 study (NCT02399085) investigating the
combination of tafasitamab and lenalidomide in patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who
have had at least one, but no more than three prior lines of
therapy, including an anti-CD20 targeting therapy (e.g.,
rituximab), who are not eligible for high-dose chemotherapy (HCD)
or autologous stem cell transplant (ASCT). The study's primary
endpoint is the best objective response rate (ORR). Secondary
outcome measures include duration of response (DoR),
progression-free survival (PFS) and overall survival (OS). The
study reached its primary completion in May
2019.
For more information about L-MIND,
visit https://clinicaltrials.gov/ct2/show/NCT02399085.
About RE-MIND
RE-MIND, an observational retrospective
study (NCT04150328), was designed to isolate the contribution of
tafasitamab in combination with lenalidomide and prove the
combinatorial effect. The study compares real-world response data
of patients with relapsed or refractory diffuse large B-cell
lymphoma (DLBCL) who received lenalidomide monotherapy with the
efficacy outcomes of the tafasitamab-lenalidomide combination, as
investigated in MorphoSys' L-MIND trial. RE-MIND collected the
efficacy data from 490 relapsed or refractory DLBCL patients in the
U.S. and EU. Qualification criteria for matching patients of both
studies were pre-specified. As a result, 76 eligible RE-MIND
patients were identified and matched 1:1 to 76 of 80 L-MIND
patients based on important baseline characteristics. Objective
Response Rates (ORR) were validated based on this subset of 76
patients in RE-MIND and L-MIND, respectively. The primary endpoint
of RE-MIND was met and shows a statistically significant superior
best ORR of the tafasitamab-lenalidomide combination compared to
lenalidomide monotherapy.
For more information about RE-MIND, visit
https://clinicaltrials.gov/ct2/show/NCT04150328.
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).
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 transplant (ASCT). This
indication is approved under accelerated approval based on the
overall response rate. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in a confirmatory trial(s).
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials. The safety and efficacy of tafasitimab in other B-cell
malignancies has not been established.
Minjuvi® and Monjuvi® are
registered trademarks of MorphoSys AG. Tafasitamab is
co-marketed by Incyte and MorphoSys under the brand name
Monjuvi® in the United
States and marketed by Incyte under the brand name
Minjuvi® in Canada.
XmAb® is a registered trademark of Xencor,
Inc.
About Incyte
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 whether and when Minjuvi,
in combination with lenalidomide, might provide a successful
treatment option for certain patients with relapsed or refractory
diffuse large B-cell lymphoma (DLBCL), the L-MIND and RE-MIND
clinical trial programs generally, and whether and when the
conditions from the Notice of Compliance may be removed, contain
predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company'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; determinations made by Canadian regulatory authorities or
other regulatory authorities, including the FDA; the Company's
dependence on its relationships with its collaboration partners;
the efficacy or safety of the Company's products and the products
of the Company's collaboration partners; the acceptance of the
Company's products and the products of the Company's 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
Securities and Exchange Commission, including its annual report for
the year ended December 31, 2020, and
the quarterly report on Form 10-Q for the quarter ended
June 30, 2021. The Company disclaims
any intent or obligation to update these forward-looking
statements.
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1 Sarkozy C, et al. Management of
relapsed/refractory DLBCL. Best Practice Research & Clinical
Haematology. 2018
31:209–16. doi.org/10.1016/j.beha.2018.07.014.
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2
Skrabek P, et al. Emerging therapies for
the treatment of relapsed or refractory diffuse large B cell
lymphoma. Current Oncology. 2019 26(4):
253–265. doi.org/10.3747/co.26.5421.
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3
Skrabek P, et al. Emerging therapies for
the treatment of relapsed or refractory diffuse large B cell
lymphoma. Current Oncology. 2019 26(4):
253–265. doi.org/10.3747/co.26.5421.
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SOURCE Incyte Biosciences Canada