Incyte (NASDAQ:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR)
today announced that the first patient has been dosed in the
pivotal Phase 3 frontMIND study evaluating tafasitamab and
lenalidomide in addition to rituximab, cyclophosphamide,
doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP
alone as first-line treatment for high-intermediate and high-risk
patients with untreated diffuse large B-cell lymphoma (DLBCL).
Tafasitamab is a humanized, monoclonal antibody designed to
effectively target the B-cell specific antigen CD19 and to induce
immune cell activation.
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“While more than half of DLBCL patients can be cured with an
aggressive chemotherapy regimen, current outcomes for high-risk
patients are poor,” said Mike Akimov, M.D., Ph.D., Head of Global
Drug Development, MorphoSys. “We believe we may be able to make a
difference for those DLBCL patients by adding the combination of
tafasitamab and lenalidomide to R-CHOP, a current standard of
care.”
Each year, approximately 30,000 patients are diagnosed with
DLBCL in the U.S. alone1,2. R-CHOP is a current standard of care
for patients with previously untreated DLBCL, but about 40% of
patients do not respond to R-CHOP or relapse – particularly those
with high-intermediate and high-risk disease3.
“Despite improvements in treatment for patients with DLBCL,
there continues to be a significant medical need for additional
therapies with improved outcomes,” said Peter Langmuir, M.D., Group
Vice President, Oncology Targeted Therapeutics, Incyte. “We are
pleased to have initiated the frontMIND study as we seek
meaningful, new options for newly diagnosed, high-risk patients
with DLBCL.”
In December 2020, encouraging preliminary data from firstMIND,
the ongoing Phase 1b, open-label, randomized study on the safety
and efficacy of R-CHOP plus either tafasitamab or tafasitamab plus
lenalidomide for patients with newly diagnosed DLBCL, were
presented at the American Society of Hematology (ASH) Annual
Meeting. The data showed a preliminary response rate of 91.1%
across both arms in a patient population that overall had a poor
prognosis, and that the combination of tafasitamab, lenalidomide
and R-CHOP has an acceptable tolerability profile. These results
informed and supported further investigation of the tafasitamab
combination in the frontMIND study.
In July 2020, the FDA approved Monjuvi® (tafasitamab-cxix) 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)4.
The FDA decision represented the first approval of a second-line
treatment for adult patients with DLBCL who progressed during or
after first-line therapy.
About Diffuse Large B-cell Lymphoma (DLBCL) DLBCL is the
most common type of non-Hodgkin lymphoma in adults worldwide5,
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, leading to a high medical
need for new, effective therapies, especially for patients who are
not eligible for an autologous stem cell transplant in this
setting6.
About frontMIND The frontMIND (NCT04824092) trial is a
randomized, double-blind, placebo-controlled, global Phase 3
clinical study in previously untreated high-intermediate and
high-risk DLBCL patients that is conducted in partnership with the
German Lymphoma Association (GLA), the Italian Lymphoma study group
and the US Oncology Network.
The study aims to enroll approximately 880 DLBCL patients to
receive either tafasitamab plus lenalidomide in addition to
rituximab, cyclophosphamide, doxorubicin, vincristine and
prednisone (R-CHOP) or R-CHOP alone. The primary endpoint is
investigator-assessed progression-free survival, according to
Lugano 2014 criteria, and key secondary endpoints include
event-free survival by investigator, overall survival, metabolic
complete response rate by a Blinded Independent Review Committee,
and overall response rate.
For more information about the frontMIND trial, visit
https://clinicaltrials.gov/ct2/show/study/NCT04824092?term=NCT04824092&draw=2&rank=1.
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 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 confirmatory
trial(s).
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 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 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, protein and peptide
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.
Monjuvi® is a registered trademark of MorphoSys AG.
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
ongoing clinical development program for tafasitamab, its frontMIND
program, its diffuse large B-cell lymphoma (DLBCL) program
generally and whether the combination of tafasitamab and
lenalidomide with R-CHOP as first-line treatment will be approved
for use in the U.S. or elsewhere for newly diagnosed patients with
DLBCL, or any other indication, 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 U.S. FDA 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 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 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-cxix as well as the commercial
performance of Monjuvi, 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.
______________________________________ References 1
Decision Resources Group. Non-Hodgkin's Lymphoma and Chronic
Lymphocytic Leukemia, Landscape & Forecast. 2020. 2 Teras, L,
et al. 2016 US Lymphoid Malignancy Statistics by World Health
Organization Subtypes. CA: A Cancer Journal for Clinicians
2016;66:443–459. 3 Sehn LH and Salles G. Diffuse Large B-Cell
Lymphoma Review. NEJM 2021.
https://www.nejm.org/doi/full/10.1056/NEJMra2027612. 4 Monjuvi®
(tafasitamab-cxix) [Package Insert]. Boston, MA: MorphoSys; 2020. 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.
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Incyte Media:
Catalina Loveman Executive Director, Public Affairs +1 302 498 6171
cloveman@incyte.com
Jenifer Antonacci Senior Director, Public Affairs +1 302 498
7036 JAntonacci@incyte.com
Investors: Christine Chiou Senior Director, Investor
Relations +1 302 274 4773 cchiou@incyte.com
MorphoSys Media:
Thomas Biegi Vice President +49 (0)89 / 89927 26079
Thomas.Biegi@morphosys.com
Jeanette Bressi Director, U.S. Communications +1 617-404-7816
jeanette.bressi@morphosys.com
Investors: Dr. Julia Neugebauer Senior Director +49 (0)89
/ 899 27 179 julia.neugebauer@morphosys.com
Myles Clouston Senior Director +1-857-772-0240
myles.clouston@morphosys.com
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