- If approved, tafasitamab in combination with
lenalidomide would represent an important new therapeutic option
for eligible DLBCL patients in the European Union
- The positive opinion from the CHMP is based
on data from the Phase 2 L-MIND study evaluating tafasitamab in
combination with lenalidomide as a treatment for patients with
relapsed or refractory DLBCL
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR)
today announced that the European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) has issued a positive
opinion recommending the conditional marketing authorization of
tafasitamab in combination with lenalidomide, followed by
tafasitamab 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).
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“The CHMP’s positive opinion of tafasitamab is a pivotal step
towards addressing an urgent unmet medical need for the 30-40% of
patients with relapsed or refractory DLBCL who do not respond to
initial therapy or relapse thereafter,” said Steven Stein, M.D.,
Chief Medical Officer, Incyte. “Following the U.S. FDA’s approval
of tafasitamab in July 2020, we eagerly await the European
Commission’s decision as we look forward to bringing this new
therapy to eligible patients in Europe as soon as possible.”
“Tafasitamab in combination with lenalidomide represents an
important new targeted treatment option for patients with relapsed
or refractory DLBCL,” said Dr. Malte Peters, Chief Research &
Development Officer, MorphoSys. “Patients with relapsed or
refractory DLBCL have limited treatment options and often face a
poor prognosis. There is an urgent need for effective therapies and
if approved, this combination could provide patients in Europe with
an important new therapeutic option.”
The CHMP opinion to recommend the use of tafasitamab is now
being reviewed by the European Commission, which has the authority
to grant marketing authorization for medicinal products in the
European Union (EU). If approved, tafasitamab would be
commercialized in the EU under the brand name Minjuvi®.
DLBCL is the most common type of non-Hodgkin lymphoma in adults
worldwide comprising 40% of all cases1 and characterized by rapidly
growing masses of malignant B-cells in the lymph nodes, spleen,
liver, bone marrow or other organs2. It is an aggressive disease
with about one in three patients not responding to initial therapy
or relapsing thereafter3. In Europe, each year approximately 16,000
patients are diagnosed with relapsed or refractory DLBCL4,5,6.
Incyte and MorphoSys share global development rights to
tafasitamab and Incyte has exclusive commercialization rights to
tafasitamab outside the United States. Incyte and MorphoSys
co-commercialize tafasitamab under the brand name Monjuvi® in the
United States.
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 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 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).
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).
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 marketed under the brand name Monjuvi® in the US. If
approved in the EU, tafasitamab will be marketed under the brand
name Minjuvi ®.
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.
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. subsidiary MorphoSys US Inc., has more than 600 employees.
More information at 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 potential grant of marketing authorization for
tafasitamab in the EU, the Company’s expectations regarding 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; greater than expected
expenses; expenses relating to litigation or strategic activities;
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 March 31, 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, including the
expectations regarding Monjuvi's/Minjuvi’s ability to treat
patients with relapsed or refractory diffuse large B-cell lymphoma,
the further clinical development of tafasitamab, including ongoing
confirmatory trials, additional interactions with regulatory
authorities and expectations regarding future regulatory filings
and possible additional approvals for tafasitamab as well as the
commercial performance of Monjuvi/Minjuvi. The words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "would," "could," "potential," "possible,"
"hope" and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. 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 MorphoSys' expectations regarding risks
and uncertainties related to the impact of the COVID-19 pandemic to
MorphoSys' business, operations, strategy, goals and anticipated
milestones, including its ongoing and planned research activities,
ability to conduct ongoing and planned clinical trials, clinical
supply of current or future drug candidates, commercial supply of
current or future approved products, and launching, marketing and
selling current or future approved products, the global
collaboration and license agreement for tafasitamab, the further
clinical development of tafasitamab, including ongoing confirmatory
trials, and MorphoSys' ability to obtain and maintain requisite
regulatory approvals and to enroll patients in its planned clinical
trials, additional interactions with regulatory authorities and
expectations regarding future regulatory filings and possible
additional approvals for tafasitamab as well as the commercial
performance of Monjuvi/Minjuvi, 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 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. 2 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. 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. 4 DRG Epidemiology
data. 5 Kantar Market Research (TPP testing 2018). 6 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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Incyte Media:
Catalina Loveman Tel: +1 302 498 6171 cloveman@incyte.com
Ela Zawislak Tel: + 41 21 581 5200 ezawislak@incyte.com
Investors: Christine Chiou Tel: +1 302 498 5914
cchiou@incyte.com
MorphoSys Media contacts:
Thomas Biegi Tel.: +49 (0)89 / 89927 26079
Thomas.Biegi@morphosys.com
Jeanette Bressi Tel: +1 617-404-7816
jeanette.bressi@morphosys.com
Investor Contact: Dr. Julia Neugebauer Tel: +49 (0)89 /
899 27 179 julia.neugebauer@morphosys.com
Myles Clouston Tel: +1-857-772-0240
myles.clouston@morphosys.com
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