- The decision by the European Commission is
based on data from the L-MIND study evaluating Minjuvi in
combination with lenalidomide as a treatment for patients with
relapsed or refractory DLBCL - Minjuvi is a new therapeutic option
for eligible DLBCL patients in the European Union (EU), addressing
an urgent unmet medical need - In Europe, each year approximately
16,000 patients are diagnosed with relapsed or refractory
DLBCL1,2,3
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR)
today announced that the European Commission (EC) has granted
conditional marketing authorization 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 transplant (ASCT). The EC decision follows the positive
opinion received from the European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) in June 2021 recommending
the conditional marketing authorization of Minjuvi.
“People living with relapsed or refractory DLBCL in the EU, have
historically had limited treatment options and a poor prognosis.
However, with the EC’s approval of Minjuvi, eligible patients now
have a new and much needed treatment option,” said Hervé Hoppenot,
Chief Executive Officer, Incyte. “We will now focus our efforts on
working with individual countries in Europe to provide people
access to this new treatment.”
“The approval of Minjuvi is a crucial milestone for patients
with relapsed or refractory DLBCL in Europe,” said Jean-Paul Kress,
M.D., Chief Executive Officer, MorphoSys. “DLBCL is the most common
type of non-Hodgkin lymphoma in adults and Minjuvi addresses an
urgent unmet medical need for the 30-40% of people who do not
respond to or relapse, after initial therapy.”
The conditional approval is based on the results from the L-MIND
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 autologous stem cell
transplant (ASCT). The results showed best objective response rate
(ORR) of 56.8% (primary endpoint), including a complete response
(CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as
assessed by an independent review committee. The median duration of
response (mDOR) was 43.9 months after a minimum follow up of 35
months (secondary endpoint). Minjuvi together with lenalidomide was
shown to provide a clinically meaningful response and the side
effects were manageable. Warnings and precautions for Minjuvi
include infusion-related reactions, myelosuppression, including
neutropenia and thrombocytopenia, infections and tumour lysis
syndrome.
“The data from the L-MIND study demonstrate the potential
benefits, including long duration of response, that tafasitamab may
have for eligible DLBCL patients,” said Professor Pier Luigi
Zinzani M.D., Ph.D., Head of the Lymphoma Group at University of
Bologna. “It is encouraging to see new treatments become available
for these patients, especially given the historical lack of
treatment options in this area.”
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 the
EU.
About Diffuse Large B-Cell Lymphoma DLBCL is the most
common type of non-Hodgkin lymphoma in adults worldwide, comprising
40% of all cases4, and is characterized by rapidly growing masses
of malignant B-cells in the lymph nodes, spleen, liver, bone marrow
or other organs5. It is an aggressive disease with about one in
three patients not responding to initial therapy or relapsing
thereafter6. In Europe, each year approximately 16,000 patients are
diagnosed with relapsed or refractory DLBCL7,8,9.
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 (HDC) or autologous stem cell
transplant (ASCT). The study’s primary endpoint is overall 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 Minjuvi® (tafasitamab) 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 overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional approval,
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 transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials.
Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG.
Tafasitamab is co-marketed by Incyte and MorphoSys under the brand
name Monjuvi® in the U.S., and marketed by Incyte under the brand
name Minjuvi® in the EU.
XmAb® is a registered trademark of Xencor, Inc.
Safety Information from the EU Summary of Product
Characteristics (SmPC) Infusion-related reactions may occur and
have been reported more frequently during the first infusion.
Patients should be monitored closely throughout the infusion and
should be advised to contact their healthcare professionals if they
experience signs and symptoms of infusion related reactions
including fever, chills, rash or breathing problems within 24 hours
of infusion. A premedication should be administered to patients
prior to starting tafasitamab infusion. Based on the severity of
the infusion-related reaction, tafasitamab infusion should be
interrupted or discontinued and appropriate medical management
should be instituted.
Fatal and serious infections, including opportunistic
infections, occurred in patients during treatment with Minjuvi.
Minjuvi should be administered to patients with an active
infection only if the infection is treated appropriately and well
controlled. Patients with a history of recurring or chronic
infections may be at increased risk of infection and should be
monitored appropriately. Patients should be advised to contact
their healthcare professionals if fever or other evidence of
potential infection, such as chills, cough or pain on urination,
develops.
Treatment with Minjuvi in combination with lenalidomide should
not be initiated in female patients unless pregnancy has been
excluded.
The most common adverse reactions were infections, neutropenia,
asthenia, anemia, diarrhea, thrombocytopenia, cough, oedema
peripheral, pyrexia and decreased appetite.
Minjuvi may cause serious adverse reactions. The most common
serious adverse reactions were infection, including pneumonia and
febrile neutropenia.
Treatment with tafasitamab can cause serious or severe
myelosuppression including neutropenia, thrombocytopenia and
anemia. Complete blood counts should be monitored throughout
treatment and prior to administration of each treatment cycle.
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.
About MorphoSys MorphoSys (FSE & NASDAQ: MOR) is a
commercial-stage biopharmaceutical company dedicated to the
discovery, development and commercialization of innovative
therapies for people living with cancer and autoimmune diseases.
Based on its leading expertise in antibody and protein
technologies, MorphoSys is advancing its own pipeline of new drug
candidates and has created antibodies which are developed by
partners in different areas of unmet medical need. In 2017,
Tremfya® (guselkumab) – developed by Janssen Research &
Development, LLC and marketed by Janssen Biotech, Inc., for the
treatment of plaque psoriasis – became the first drug based on
MorphoSys’ antibody technology to receive regulatory approval. In
July 2020, the U.S. Food and Drug Administration (FDA) granted
accelerated approval of the company’s proprietary product Monjuvi®
(tafasitamab-cxix) in combination with lenalidomide in patients
with a certain type of lymphoma. Headquartered near Munich,
Germany, the MorphoSys Group, including the fully owned U.S.
subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals,
Inc., has more than 750 employees. For more information visit
www.morphosys.com or www.morphosys-us.com.
Tremfya® is a registered trademark of Janssen Biotech, Inc.
Incyte Forward-looking Statements Except for the
historical information set forth herein, the matters set forth in
this press release, including statements regarding the Company’s
expectations relating to the use of tafasitamab for treatment of
adult patients with relapsed or refractory diffuse large B-cell
lymphoma (DLBCL), the Company’s ongoing clinical development
program for tafasitamab, and its DLBCL program generally, 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 and the ability to enroll subjects in accordance with
planned schedules; the effects of the COVID-19 pandemic and
measures to address the pandemic on the Company’s clinical trials,
supply chain, and other third-party providers and development and
discovery operations; determinations made by the European
Commission and other regulatory authorities; 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 and
its 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.
MorphoSys Forward-looking Statements This communication
contains certain forward-looking statements concerning the
MorphoSys group of companies. The forward-looking statements
contained herein represent the judgment of MorphoSys as of the date
of this release and involve known and unknown risks and
uncertainties, which might cause the actual results, financial
condition and liquidity, performance or achievements of MorphoSys,
or industry results, to be materially different from any historic
or future results, financial conditions and liquidity, performance
or achievements expressed or implied by such forward-looking
statements. In addition, even if MorphoSys' results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are that MorphoSys' expectations may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements, MorphoSys' reliance on
collaborations with third parties, estimating the commercial
potential of its development programs and other risks indicated in
the risk factors included in MorphoSys' Annual Report on Form 20-F
and other filings with the U.S. Securities and Exchange Commission.
Given these uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
of this document. MorphoSys expressly disclaims any obligation to
update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or regulation.
_____________________ 1 DRG Epidemiology data. 2 Kantar Market
Research (TPP testing 2018). 3 Friedberg, Jonathan W.
Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am
Soc Hematol Educ Program 2011; 2011:498-505. doi:
10.1182/asheducation-2011.1.498. 4 Cancer Research UK. Diffuse
large B cell lymphoma. Available at
https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma.
Accessed: May 2021. 5 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. 6
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. 7 DRG Epidemiology
data. 8 Kantar Market Research (TPP testing 2018). 9 Friedberg,
Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma.
Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi:
10.1182/asheducation-2011.1.498.
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version on businesswire.com: https://www.businesswire.com/news/home/20210826005704/en/
Incyte Media: Ela
Zawislak +41 21 581 5200 ezawislak@incyte.com
Catalina Loveman +1 302 498 6171 cloveman@incyte.com
Investors: Christine Chiou +1 302 498 5914
cchiou@incyte.com
MorphoSys Media:
Thomas Biegi +49 (0)89 / 89927 26079 Thomas.Biegi@morphosys.com
Jeanette Bressi +1-617-404-7816
jeanette.bressi@morphosys.com
Investors: Dr. Julia Neugebauer +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
Myles Clouston +1-857-772-0240 myles.clouston@morphosys.com
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