- First FDA approval of a second-line treatment
for adult patients with relapsed or refractory DLBCL, helping fill
a high unmet medical need
- FDA granted Monjuvi Fast Track, Breakthrough
Therapy and Priority Review designations
- MorphoSys and Incyte will co-commercialize
Monjuvi in the United States
- Joint analyst and investor conference call
and webcast scheduled for Monday, August 3, 2020 at 8:00 a.m. EDT /
2:00 p.m. CEST
MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX &
TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that
the U.S. Food and Drug Administration (FDA) has approved Monjuvi®
(tafasitamab-cxix) 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).1 Monjuvi, a humanized
Fc-modified cytolytic CD19 targeting monoclonal antibody, has been
approved under accelerated approval by the U.S. FDA based on
overall response rate (ORR). Continued approval may be contingent
upon verification and description of clinical benefit in a
confirmatory trial(s). The FDA decision represents the first
approval of a second-line treatment for adult patients who
progressed during or after first-line therapy.
DLBCL is the most common type of non-Hodgkin lymphoma in adults
worldwide2, 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 one in three
patients not responding to initial therapy or relapsing
thereafter.3 In the United States each year approximately 10,000
patients are diagnosed with relapsed or refractory DLBCL who are
not eligible for ASCT.4,5,6
“We are incredibly proud that the FDA has approved Monjuvi in
combination with lenalidomide as the first treatment in second-line
for patients with relapsed or refractory DLBCL, and we thank all
the health care professionals, patients and families involved in
our Monjuvi trials,” said Jean-Paul Kress, M.D., Chief Executive
Officer, MorphoSys. “This approval marks an important step in
MorphoSys’ transformation into a fully integrated biopharmaceutical
company. We remain committed to developing innovative treatments to
improve the lives of patients with serious diseases.”
“The FDA approval of Monjuvi in combination with lenalidomide
helps address an urgent unmet medical need for patients with
relapsed or refractory DLBCL in the United States,” said Hervé
Hoppenot, Chief Executive Officer, Incyte. “At Incyte we are
committed to advancing patient care and are proud to bring this new
and much-needed targeted therapeutic option to appropriate patients
and the clinical community.”
“The FDA approval of Monjuvi brings a new treatment option to
patients in dire need across the United States,” said Professor
Gilles Salles, M.D., Chair of the Clinical Hematology Department at
the University of Lyon, France, and lead investigator of the L-MIND
study. “Today’s FDA decision offers new hope for patients with this
aggressive form of DLBCL who progressed during or after first-line
therapy.”
The FDA approval was based on data from the MorphoSys-sponsored
Phase 2 L-MIND study, an open label, multicenter, single arm trial
of Monjuvi in combination with lenalidomide as a treatment for
adult patients with relapsed or refractory DLBCL. Results from the
study showed an overall response rate (ORR) of 55% (primary
endpoint), including a complete response (CR) rate of 37% and a
partial response rate (PR) of 18%. The median duration of response
(mDOR) was 21.7 months (key secondary endpoint).1 Warnings and
Precautions for Monjuvi included infusion-related reactions (6%),
serious or severe myelosuppression (including neutropenia (50%),
thrombocytopenia (18%), and anemia (7%)), infections (73%) and
embryo-fetal toxicity. Neutropenia led to treatment discontinuation
in 3.7% of patients. The most common adverse reactions (≥ 20%) were
neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough,
pyrexia, peripheral edema, respiratory tract infection, and
decreased appetite.
The FDA previously granted Fast Track and Breakthrough Therapy
Designation for the combination of Monjuvi and lenalidomide in
relapsed or refractory DLBCL. FDA Breakthrough Therapy designation
is intended to expedite development and review of drug candidates.
It is granted if preliminary clinical evidence indicates that the
drug candidate may demonstrate substantial improvement over
existing therapies in the treatment of a serious or
life-threatening disease. The Biologics License Application (BLA)
for Monjuvi was granted Priority Review and approved under the
FDA’s Accelerated Approval program.
Monjuvi is expected to be commercially available in the United
States shortly. MorphoSys and Incyte will co-commercialize Monjuvi
in the United States. Incyte has exclusive commercialization rights
outside the United States.
MorphoSys and Incyte are committed to supporting patients
throughout their treatment journeys and are working together to
help lower patient access barriers. As part of this commitment, the
Companies have launched My Mission Support, a robust patient
support program offering financial assistance, ongoing education
and other resources to eligible patients who are prescribed Monjuvi
in the United States. Program information will be available online
at www.MyMissionSupport.com.
Conference Call Information MorphoSys and Incyte will
host an analyst and investor conference call and webcast on Monday,
August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST. The live webcast
and replay will be available via www.morphosys.com and
investor.incyte.com.
To access the conference call, please dial 877-407-3042 for
callers in the United States or +1 201-389-0864 for callers outside
the United States. When prompted, provide the conference
identification number 13706810.
If you are unable to participate, a replay of the conference
call will be available for 90 days. The replay dial-in number for
the United States is 877-660-6853 and the dial-in number for
international callers is +1 201-612-7415. To access the replay, you
will need the conference identification number 13706810.
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 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
https://clinicaltrials.gov/ct2/show/NCT02399085.
About Monjuvi® (tafasitamab-cxix) Monjuvi 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 is approved by the U.S. Food and Drug Administration 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).
In January 2020, MorphoSys and Incyte entered into a
collaboration and licensing agreement to further develop and
commercialize Monjuvi globally. Monjuvi will be co-commercialized
by Incyte and MorphoSys in the United States. Incyte has exclusive
commercialization rights outside the United States.
A marketing authorization application (MAA) seeking the approval
of tafasitamab in combination with lenalidomide in the EU has been
validated by the European Medicines Agency (EMA) and is currently
under review for the treatment of adult patients with relapsed or
refractory DLBCL, including DLBCL arising from low grade lymphoma,
who are not candidates for ASCT.
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in a number of ongoing combination
trials.
Monjuvi is a registered trademark of MorphoSys AG. XmAb® is a
registered trademark of Xencor, Inc.
Important Safety Information What are the possible side
effects of MONJUVI? MONJUVI may cause serious side effects,
including:
- Infusion reactions. Your healthcare provider will monitor you
for infusion reactions during your infusion of MONJUVI. Tell your
healthcare provider right away if you get chills, flushing,
headache, or shortness of breath during an infusion of
MONJUVI.
- Low blood cell counts (platelets, red blood cells, and white
blood cells). Low blood cell counts are common with MONJUVI, but
can also be serious or severe. Your healthcare provider will
monitor your blood counts during treatment with MONJUVI. Tell your
healthcare provider right away if you get a fever of 100.4°F (38°C)
or above, or any bruising or bleeding.
- Infections. Serious infections, including infections that can
cause death, have happened in people during treatments with MONJUVI
and after the last dose. Tell your healthcare provider right away
if you get a fever of 100.4°F (38°C) or above, or develop any signs
and symptoms of an infection.
The most common side effects of MONJUVI include:
- Feeling tired or weak
- Diarrhea
- Cough
- Fever
- Swelling of lower legs or hands
- Respiratory tract infection
- Decreased appetite
These are not all the possible side effects of MONJUVI.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Before you receive MONJUVI, tell your healthcare provider
about all your medical conditions, including if you:
- Have an active infection or have had one recently.
- Are pregnant or plan to become pregnant. MONJUVI may harm your
unborn baby. You should not become pregnant during treatment with
MONJUVI. Do not receive treatment with MONJUVI in combination with
lenalidomide if you are pregnant because lenalidomide can cause
birth defects and death of your unborn baby.
- You should use an effective method of birth control
(contraception) during treatment and for at least 3 months after
your final dose of MONJUVI.
- Tell your healthcare provider right away if you become pregnant
or think that you may be pregnant during treatment with
MONJUVI.
- Are breastfeeding or plan to breastfeed. It is not known if
MONJUVI passes into your breastmilk. Do not breastfeed during
treatment for at least 3 months after your last dose of
MONJUVI.
You should also read the lenalidomide Medication Guide for
important information about pregnancy, contraception, and blood and
sperm donation.
Tell your healthcare provider about all the medications you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
Please see the full Prescribing Information for Monjuvi,
including Patient Information, for additional Important Safety
Information.
About MorphoSys MorphoSys 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, 27 of which are currently in clinical development. In
2017, Tremfya®, marketed by Janssen for the treatment of plaque
psoriasis, became the first drug based on MorphoSys' antibody
technology to receive regulatory approval. 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.
Tremfya® is a registered trademark of Janssen Biotech.
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.
MorphoSys Forward-Looking Statements This communication
contains certain forward-looking statements concerning the
MorphoSys group of companies, including the expectations regarding
tafasitamab’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 tafasitamab.
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 tafasitamab, 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.
Incyte Forward-Looking Statements Except for the
historical information set forth herein, the matters set forth in
this press release contain predictions, estimates and other
forward-looking statements, including without limitation statements
regarding: tafasitamab’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 tafasitamab. These forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially, including unanticipated developments in and
risks related to: obtaining regulatory approval for this planned
collaboration; research and development efforts related to the
collaboration programs; the possibility that results of clinical
trials may be unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; other market
or economic factors, including other scientific developments;
unanticipated delays; the effects of market competition; risks
associated with relationships between collaboration partners; the
impact of governmental actions regarding pricing, importation and
reimbursement for pharmaceuticals; and such other risks detailed
from time to time in each company's reports filed with the U.S.
Securities and Exchange Commission, including Incyte's annual
report on Form 10-Q for the quarter ending March 31, 2020 and
MorphoSys' Annual Report on Form 20-F for the fiscal year ended
December 31, 2019. Each party disclaims any intent or obligation to
update these forward-looking statements.
References
- Monjuvi® (tafasitamab-cxix) Prescribing Information. Boston,
MA, MorphoSys.
- 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.
- 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.
- DRG Epidemiology data.
- Kantar Market Research (TPP testing 2018).
- 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/20200731005497/en/
MorphoSys Media:
Jeanette Bressi Director, US Communications +1 617-404-7816
media@morphosys.com
Dr. Anca Ammon Associate Director +49 (0)89 899 27 26738
media@morphosys.com
Investors: Dr. Anja Pomrehn Senior Vice President +49
(0)89 / 899 27 26972 anja.pomrehn@morphosys.com
Dr. Julia Neugebauer Director +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
Incyte Media:
Catalina Loveman Executive Director, Public Affairs +1 302 498 6171
cloveman@incyte.com
Jenifer Antonacci Senior Director, U.S. Public Affairs +1 302
498 7036 jantonacci@incyte.com
Investors: Dr. Michael Booth Division VP, IR & Global
Responsibility +1 302 498 5914 mbooth@incyte.com
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