DGAP-News: MorphoSys AG / Key word(s): Miscellaneous
MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing
Authorization Application for Tafasitamab
2021-01-05 / 08:00
The issuer is solely responsible for the content of this announcement.
*MorphoSys and Incyte Announce the Acceptance of the Swissmedic Marketing
Authorization Application for Tafasitamab*
*- *_The Swissmedic MAA seeks approval for tafasitamab in combination with
lenalidomide for the treatment of adult patients with relapsed or refractory
diffuse large B-cell lymphoma_
*PLANEGG/MUNICH, Germany and MORGES, Switzerland - January 5, 2021 *-
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR)
and Incyte (NASDAQ:INCY) today announced that the Swiss Agency for
Therapeutic Products (Swissmedic) has accepted the marketing authorization
application (MAA) for tafasitamab, a humanized Fc-modified cytolytic CD19
targeting monoclonal antibody. The MAA seeks approval for 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), including DLBCL arising from low grade lymphoma, who are
not candidates for autologous stem cell transplantation (ASCT). The MAA will
now enter the formal review process by Swissmedic.
The Swissmedic MAA for tafasitamab will be reviewed as part of the U.S. Food
and Drug Administration's (FDA) modified Project Orbis, which provides a
framework for concurrent submission and review of oncology drug applications
among the FDA's international collaborators. Collaboration among
international regulators may allow patients with cancer to receive earlier
access to products in other countries.
"Currently about 40% of DLBCL patients do not respond to initial therapy or
relapse thereafter leading to a high medical need for new, effective
therapies," said Peter Langmuir, M.D., Group Vice President, Targeted
Therapeutics, Incyte. "The acceptance of the MAA for tafasitamab for review
by Swissmedic is a pivotal step towards bringing tafasitamab in combination
with lenalidomide to eligible patients in Switzerland."
"Tafasitamab in combination with lenalidomide may represent an important new
targeted treatment option for patients with relapsed or refractory DLBCL,"
said Mike Akimov, M.D., Ph.D., Head of Global Clinical Development,
MorphoSys. "We look forward to continuing to work with the regulatory
authorities alongside our partners at Incyte to bring this novel therapeutic
option to eligible patients with a high unmet medical need."
The Swissmedic application, submitted by Incyte in collaboration with
MorphoSys, is supported by data from the L-MIND study evaluating tafasitamab
in combination with lenalidomide as a treatment for patients with relapsed
or refractory DLBCL and data from the RE-MIND study, an observational
retrospective study in relapsed or refractory DLBCL. If approved, Incyte
will hold the marketing authorization, and have exclusive commercialization
rights for tafasitamab in Switzerland.
Incyte has exclusive commercialization rights for tafasitamab outside the
*About Diffuse Large B-cell Lymphoma (DLBCL)*
DLBCL is the most common type of non-Hodgkin lymphoma in adults
worldwide, 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 thereafter. In Europe, each year approximately
16,000 patients are diagnosed with relapsed or refractory DLBCL,,.
The L-MIND trial is a single arm, open-label, multicenter 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 or refuse subsequent autologous stem
cell transplant. 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). In May 2019, the
study reached its primary completion.
For more information about L-MIND, visit
RE-MIND, an observational retrospective study (NCT04150328), was designed to
isolate the contribution of tafasitamab in combination with lenalidomide and
to 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 the 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
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(R) 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(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug
Administration (FDA) 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, 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
In January 2020, MorphoSys and Incyte entered into a collaboration and
licensing agreement to further develop and commercialize tafasitamab
globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the
United States. Incyte has exclusive commercialization rights outside the
Tafasitamab is being clinically investigated as a therapeutic option in
B-cell malignancies in a number of ongoing combination trials.
Monjuvi(R) is a registered trademark of MorphoSys AG.
XmAb(R) is a registered trademark of Xencor, Inc.
MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical
company dedicated to the discovery, development and commercialization of
exceptional, innovative therapies for patients suffering from serious
diseases. The focus is on cancer. Based on its leading expertise in
antibody, protein and peptide technologies, MorphoSys, together with its
partners, has developed and contributed to the development of more than 100
product candidates, of which 27 are currently in clinical development. In
2017, Tremfya(R), 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 MorphoSys' proprietary product
Monjuvi(R) (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 500 employees. More
information at www.morphosys.com  or www.morphosys-us.com .
Monjuvi(R) is a registered trademark of MorphoSys AG.
Tremfya(R) is a registered trademark of Janssen Biotech, 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
_MorphoSys Forward-looking Statements _
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, including the expectations regarding
Monjuvi's ability to treat patients with relapsed or refractory diffuse
large B-cell lymphoma, the further clinical development of tafasitamab-cxix,
including ongoing confirmatory trials, additional interactions with
regulatory authorities and expectations regarding future regulatory filings
and possible additional approvals for tafasitamab-cxix as well as the
commercial performance of Monjuvi. 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
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