- Preliminary safety and efficacy data
from Phase 1b firstMIND trial in patients with newly diagnosed
diffuse large B-cell lymphoma (DLBCL) presented today
- Also presented today: Long-term subgroup
analyses from L-MIND study evaluating tafasitamab combined with
lenalidomide in patients with relapsed or refractory DLBCL
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard
Segment; MDAX & TecDAX; NASDAQ:MOR) announce that preliminary
data from firstMIND, the ongoing Phase 1b, open-label, randomized
study on the safety and efficacy of tafasitamab or tafasitamab plus
lenalidomide in addition to R-CHOP for patients with newly
diagnosed diffuse large B-cell lymphoma (DLBCL) were presented
today during the 62nd American Society of Hematology Annual Meeting
& Exposition (ASH). Additionally, a long-term subgroup analysis
of the L-MIND study investigating tafasitamab combined with
lenalidomide in patients with relapsed or refractory DLBCL was also
presented at ASH.
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The preliminary results of firstMIND indicate that tafasitamab
plus lenalidomide in addition to R-CHOP shows an acceptable
tolerability profile. Toxicities appear to be similar to what is
expected with R-CHOP alone or in combination with lenalidomide.
Serious or severe neutropenia and thrombocytopenia events (grade 3
or higher) were more frequent in the tafasitamab plus lenalidomide
arm. The incidence of febrile neutropenia was comparable between
both arms and the average relative dose intensity of R-CHOP was
maintained in both arms. Interim response assessments after three
cycles were available for 45 patients. In both arms combined, 41/45
(91.1%) of patients had an objective response as per Lugano
20141.
The preliminary data from this ongoing study in first-line DLBCL
warrant further investigation. To that end, MorphoSys and Incyte
plan to initiate frontMIND, a Phase 3 trial evaluating tafasitamab
plus lenalidomide in combination with R-CHOP compared to R-CHOP
alone as first-line treatment for patients with newly diagnosed
DLBCL.
“The initial results of the firstMIND study, shared today at
ASH, as well as the long-term analyses from L-MIND, underscore the
potential of tafasitamab as a combination therapeutic for patients
with DLBCL, where there remains a significant unmet need. Along
with our partners at MorphoSys, we are pleased to be moving forward
with the initiation of a Phase 3 study in 2021,” said Steven Stein,
M.D., Chief Medical Officer at Incyte.
“The preliminary firstMIND study results mark another important
step as we explore the potential of tafasitamab as a backbone
therapy,” said Dr. Malte Peters, Chief Research and Development
Officer at MorphoSys. “Given the data available to date, including
data from the L-MIND study, we believe that the mechanism of
action, efficacy and safety profile of tafasitamab have the
potential to make it a preferred combination partner as we seek to
transform the standard of care in DLBCL. We are committed to
developing innovative therapies to battle this aggressive disease
for the benefit of patients with DLBCL, and look forward to
beginning the planned frontMIND in the first half of 2021.”
In addition to the firstMIND data presented today, the long-term
L-MIND analyses showed that treatment with tafasitamab plus
lenalidomide resulted in durable responses after ≥2 years of
follow-up. At the time of analysis, patients with complete
responses (CR) continued to experience durable treatment responses,
including long duration of response (DoR) and overall survival
(OS). The data also showed that tafasitamab plus lenalidomide taken
for 12 cycles, followed by tafasitamab until progression, did not
result in any unexpected safety signals2.
In July 2020, the FDA approved Monjuvi® (tafasitamab-cxix), a
humanized Fc-modified cytolytic CD19-targeting monoclonal antibody,
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)3.
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
worldwide4, 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
thereafter5. In the United States each year, approximately 10,000
patients are diagnosed with relapsed or refractory DLBCL who are
not eligible for autologous stem cell transplant (ASCT)6,7,8.
About firstMIND
The firstMIND (NCT04134936) trial is a Phase 1b, randomized
study of tafasitamab + R-CHOP (Arm A) or tafasitamab + lenalidomide
+ R-CHOP (Arm B) in patients with newly diagnosed diffuse large
B-cell lymphoma (DLBCL). The study includes a safety run-in phase
and a main phase. In the safety run-in phase, 24 patients were
enrolled. The primary objective is to assess safety; secondary
objectives include objective response rate, PET negative complete
response (PET-CR) rate at end of treatment, progression-free
survival, event-free survival, long-term safety, pharmacokinetics
and immunogenicity of tafasitamab.
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 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®, 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®
(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® 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
about: plans to initiate frontMIND, a Phase 3 trial evaluating
tafasitamab plus lenalidomide in combination with R-CHOP compared
to R-CHOP alone as first-line treatment for patients with newly
diagnosed DLBC; whether the mechanism of action, efficacy and
safety profile of tafasitamab have the potential to make it a
preferred or ideal combination partner in the treatment of DLBCL
and, whether it will change or become the standard of care for the
treatment of DLBCL; whether and when, if ever, confirmatory trials
of tafasitamab will result in the conditional FDA approval of
tafasitamab in the conditionally approved indication described
above becoming a final approval; whether and when, if ever, the EMA
will approve the filed MAA for tafasitamab; and additional
development of tafasitamab, including in B-cell malignancies -
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on the Incyte’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; determinations made by the FDA or the EMA; clinical and
commercial supply of products in development or being
commercialized; Incyte’s dependence on its relationships with its
collaboration partners; the efficacy or safety of Incyte’s products
and the products of its collaboration partners; the acceptance of
Incyte’s products and the products of its 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 Incyte’s reports
filed with the Securities and Exchange Commission, including its
quarterly report on Form 10-Q for the quarter ended September 30,
2020. Incyte 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.
1 Belada D, M.D., Ph.D., et al. A Phase 1b, Open-label,
Randomized Study to Assess Safety and Preliminary Efficacy of
Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to
R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell
Lymphoma: Analysis of the Safety Run-In Phase. 62nd American
Society of Hematology Annual Meeting & Exposition (ASH).
Abstract #3028.
2 Maddocks KJ, M.D., et al. Long-Term Subgroup Analyses from
L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with
Lenalidomide in Patients with Relapsed or Refractory Diffuse Large
B-Cell Lymphoma. 62nd American Society of Hematology Annual Meeting
& Exposition (ASH). Abstract #3021.
3 Monjuvi® (tafasitamab-cxix) Prescribing Information. Boston,
MA, MorphoSys.
4 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.
5 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.
6 DRG Epidemiology data.
7 Kantar Market Research (TPP testing 2018).
8 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 Contacts: Catalina Loveman Executive
Director, Public Affairs Tel: +1 302 498 6171
cloveman@incyte.com
Jenifer Antonacci Senior Director, Public Affairs Tel: +1 302
498 7036 jantonacci@incyte.com
Investor Contacts: Dr. Michael Booth Division VP, IR
& Global Responsibility Tel: +1 302 498 5914
mbooth@incyte.com
Christine Chiou Senior Director, Investor Relations Tel: +1 302
274 4773 cchiou@incyte.com
MorphoSys:
Media Contacts: Thomas Biegi Vice President Tel.: +49
(0)89 / 89927 26079 Thomas.Biegi@morphosys.com
Jeanette Bressi Director, US Communications Tel: +1 617-404-7816
jeanette.bressi@morphosys.com
Investor Contact: Dr. Julia Neugebauer Director, Investor
Relations Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
MorphoSys (NASDAQ:MOR)
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