- Phase 3 inMIND trial evaluating the efficacy
and safety of tafasitamab (Monjuvi®) or placebo in combination with
lenalidomide and rituximab met its primary endpoint of progression
free survival (PFS) in relapsed or refractory follicular lymphoma
(FL)
- Based on these results, Incyte expects to
file a supplemental Biologics License Application for tafasitamab
in combination with lenalidomide and rituximab in FL by the end of
the year
Incyte (Nasdaq: INCY) today announces positive topline results
from the pivotal Phase 3 inMIND trial evaluating the efficacy and
safety of tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic
CD19 targeting monoclonal antibody, or placebo in combination with
lenalidomide and rituximab compared to lenalidomide and rituximab
alone in patients with relapsed or refractory follicular lymphoma
(FL).
The trial met its primary endpoint of progression free survival
(PFS) by investigator assessment in FL. It also met key secondary
endpoints of PFS in the overall population by investigator
assessment as well as the positron-emission tomography-complete
response rate in the FDG-avid FL population. In addition, the
secondary endpoint of PFS results by blinded independent review are
consistent with investigator based PFS results. No new safety
signals with tafasitamab were observed.
“While many patients with follicular lymphoma initially benefit
from first-line treatment, relapse of the disease is common,
underscoring the need for additional therapies,” said Steven Stein,
M.D., Chief Medical Officer, Incyte. “These results demonstrate the
potential of tafasitamab added to the standard of care to be a
meaningful new treatment option for patients with FL whose disease
has progressed after at least one prior therapy.”
FL is the most common indolent, or slow growing, form of B-cell
non-Hodgkin lymphoma (NHL) and accounts for approximately 13-26% of
overall NHL cases.1,2,3,4,5 There are limited treatment options for
the more than 17,000 new cases of relapsed or refractory FL treated
every year in the United States, Europe and Japan.6
Based on these positive results, Incyte expects to file a
supplemental Biologics License Application for tafasitamab for the
treatment of patients with FL who have failed at least one prior
systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end
of the year.
The full inMIND data will also be submitted for presentation at
an upcoming scientific meeting.
Tafasitamab was approved in combination with lenalidomide by the
U.S. Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) in 2020 and 2021 respectively, for 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. Tafasitamab is marketed as Monjuvi® (tafasitamab-cxix)
in the United States and Minjuvi® (tafasitamab) in Europe and
Canada.
About inMIND
A global, double-blind, randomized, controlled Phase 3 study,
inMIND (NCT04680052) evaluated the clinical benefit of tafasitamab
and lenalidomide as an add-on to rituximab compared with
lenalidomide alone as an add-on to rituximab in patients with
relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or
relapsed or refractory nodal, splenic or extranodal marginal zone
lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18
years).
The primary endpoint of the study is progression-free survival
(PFS) by investigator assessment in the FL population, and the key
secondary endpoints are PFS in the overall population as well as
positron emission tomography complete response (PET-CR) and overall
survival (OS) in the FL population.
For more information about the study, please visit
https://clinicaltrials.gov/study/NCT04680052.
About Tafasitamab
Tafasitamab (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). MorphoSys and Incyte entered into: (a) in January 2020, a
collaboration and licensing agreement to develop and commercialize
tafasitamab globally; and (b) in February 2024, an agreement
whereby Incyte obtained exclusive rights to develop and
commercialize tafasitamab globally.
In the United States, Monjuvi® (tafasitamab-cxix) received
accelerated approval 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 Europe, Minjuvi® (tafasitamab) received
conditional Marketing Authorization from the European Medicines
Agency in combination with lenalidomide, followed by Minjuvi
monotherapy, for the treatment of adult patients with relapsed or
refractory DLBCL who are not eligible for ASCT.
XmAb® is a registered trademark of Xencor, Inc.
Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the
“triangle” design are registered trademarks of Incyte.
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 fever, 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 treatment 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. Your
healthcare provider will give you medicines before each infusion to
decrease your chance of infusion reactions. If you do not have any
reactions, your healthcare provider may decide that you do not need
these medicines with later infusions. Your healthcare provider may
need to delay or completely stop treatment with MONJUVI if you have
severe side effects.
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 of 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
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or
follow us on social media: LinkedIn, X, Instagram,
Facebook,YouTube.
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 for tafasitamab to provide a successful
treatment option for patients with FL and Incyte’s expectations
with respect to filing a supplemental Biologics License Application
for tafasitamab, contains predictions, estimates and other
forward-looking statements.
These forward-looking statements are based on 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 U.S. FDA and other regulatory
authorities outside of the United States; the efficacy or safety of
Incyte’s products; the acceptance of Incyte’s products in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; and other risks detailed from time
to time in Incyte's reports filed with the Securities and Exchange
Commission, including its annual report on Form 10-K for the year
ended December 31, 2023 and subsequent quarterly reports on Form
10-Q.. Incyte disclaims any intent or obligation to update these
forward-looking statements.
1 Al-Hamadani M, et al. Am J Hematol. 2015;90(9):790-795. 2
Chihara D, et al. Br J Haematol. 2014;164(4):536-545. 3 Perry AM,
et al. Haematologica. 2016;101(10):1244-1250. 4 Teras LR, et al. CA
Cancer J Clin. 2016;66(6):443-459. 5 Thandra KC, et al. Med Sci
(Basel). 2021;9(1):5. 6 Decision Resources Group. Non-Hodgkin’s
Lymphoma and Chronic Lymphocytic Leukemia, Landscape &
Forecast. 2020.
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