- Results from the Phase 2 L-MIND study were
highlighted as a late-breaking oral presentation at the American
Association for Cancer Research Annual Meeting 2023
MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG
(FSE: MOR; NASDAQ: MOR), and Incyte (Nasdaq: INCY) today announced
final five-year follow-up data from the Phase 2 L-MIND study
showing that Monjuvi® (tafasitamab-cxix) plus lenalidomide followed
by Monjuvi monotherapy provided prolonged, durable responses in
adult patients with relapsed or refractory diffuse large B-cell
lymphoma (DLBCL). These data were featured as a late-breaking oral
presentation (Abstract # CT022) at the American Association for
Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida.
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“Five-year data demonstrating durability of response is
meaningful for oncologists as they consider the most appropriate
treatment option for a patient,” said Johannes Duell, M.D.,
University Hospital Würzburg Medical Clinic and Polyclinic. “The
prolonged and durable responses seen at five years among relapsed
or refractory DLBCL patients in the L-MIND study show that the
Monjuvi treatment regimen may have curative potential, which I look
forward to seeing explored in future studies.”
At the data cut-off (Nov. 14, 2022) for the full analysis set
(80 patients), the overall response rate (ORR) was 57.5% (95% CI =
45.9, 68.5), and a complete response (CR) was observed in 41.2% of
patients (95% CI = 30.4, 51.6; n = 33). A partial response (PR) was
observed in 16.2% of patients (95% CI = 8.9, 26.2; n =13).
Additional results include:
- Median duration of response was not reached after a median
follow up of 44.0 months (95% CI = 29.9, 57.0).
- The median overall survival was 33.5 months (95% CI = 18.3, NR)
and median progression-free survival was 11.6 months (95% CI = 5.7,
45.7).
- Of the 21 patients with >60 months of follow-up, 14 had
received one prior line of therapy (pLoT), and seven patients had
received ≥2 pLoT.
- Patients with one pLoT (n = 40) had a higher ORR of 67.5% (CR =
52.5% and PR = 15%) compared to 47.5% of patients with two or more
pLoT (n = 40; CR = 30% and PR = 17.5%)
No new safety signals were identified. The majority of adverse
events (AEs) were grade 1 or grade 2 during both combination and
monotherapy treatment. Patients experienced a lower frequency of
all-grade and grade 3 or higher adverse events during monotherapy.
The most common adverse events with combination therapy were
neutropenia (incidence per person per year, all-grade/grade ≥3:
3.79/2.09) and thrombocytopenia (1.52/0.52), which declined after
patients switched to monotherapy (all-grade/grade ≥3: 1.09/0.70 and
0.17/0.06, respectively, in the first two years of monotherapy).
Neutropenia and diarrhea were the most common adverse events in the
first two years of monotherapy.
“The totality of the long-term L-MIND data presented at AACR
further reinforce our confidence that the Monjuvi plus lenalidomide
combination remains the in-practice, outpatient, targeted
immunotherapy option that can provide sustained remissions for
patients with relapsed or refractory DLBCL who are not eligible for
autologous stem cell transplant,” said Tim Demuth, M.D., Ph.D.,
Chief Research and Development Officer, MorphoSys. “The durable
responses and consistent safety profile observed in the five-year
analysis are encouraging and further support the use of the Monjuvi
regimen as a potentially curative option for appropriate
patients.”
“The new five-year L-MIND data build on prior analyses that
detail the potential for Monjuvi plus lenalidomide to provide
long-term, meaningful responses for certain patients with relapsed
or refractory DLBCL, a historically difficult-to-treat form of the
disease,” said Steven Stein, M.D., Chief Medical Officer, Incyte.
“We look forward to continuing to explore the potential of Monjuvi
to help patients with newly diagnosed DLBCL, as well as other
CD19-expressing lymphomas.”
In July 2020, the U.S. Food and Drug Administration (FDA)
approved Monjuvi 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 ASCT. This indication is approved under
accelerated approval based on ORR. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial(s). The U.S. approval is
based on an efficacy subgroup of 71 patients confirmed by central
lab. 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. Monjuvi, in combination with
lenalidomide, was granted accelerated approval based on the
one-year primary analysis of the L-MIND study. The data for the
five-year analysis of the L-MIND study have not yet been submitted
to, or reviewed by, the FDA.
About Diffuse Large B-cell Lymphoma (DLBCL) DLBCL is the
most common type of non-Hodgkin lymphoma in adults worldwide1,
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 thereafter2, leading to a high medical
need for new, effective therapies2, especially for patients who are
not eligible for an autologous stem cell transplant in this
setting.
About L-MIND The L-MIND trial was 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 who had at
least one, but no more than three, prior lines of therapy,
including an anti-CD20 targeting therapy (e.g., rituximab), who
were not eligible for high-dose chemotherapy or refused subsequent
autologous stem cell transplant. The study’s primary endpoint was
overall response rate. Secondary outcome measures included duration
of response, progression-free survival and overall survival. 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) Tafasitamab is a
humanized Fc-modified CD19 targeting immunotherapy. 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).
In the United States, 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 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 Europe, Minjuvi® (tafasitamab) received conditional marketing
authorization in combination with lenalidomide, followed by Minjuvi
monotherapy, for the treatment of adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) who are not
eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials.
Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG.
Tafasitamab is co-marketed by Incyte and MorphoSys under the brand
name Monjuvi® in the U.S., and marketed by Incyte under the brand
name Minjuvi® in Europe and Canada.
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-related 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,
rash, 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 At MorphoSys, we are driven by our
mission: More life for people with cancer. As a global
commercial-stage biopharmaceutical company, we develop and deliver
innovative medicines, aspiring to redefine how cancer is treated.
MorphoSys is headquartered in Planegg, Germany, and has its U.S.
operations anchored in Boston, Massachusetts. To learn more, visit
us at www.morphosys.com and follow us on Twitter and LinkedIn.
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. 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 that MorphoSys' expectations may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements, 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
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; the effects of the COVID-19 pandemic
and measures to address the pandemic on Incyte and its partners’
clinical trials, supply chain, other third-party providers and
development and discovery operations; determinations made by the
U.S. FDA and other regulatory authorities outside of the United
States; the efficacy or safety of Incyte and its partners’
products; the acceptance of Incyte and its partners’ 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 for
the year ended December 31, 2022. Incyte disclaims any intent or
obligation to update these forward-looking statements.
References
- 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230416005053/en/
For more information: MorphoSys
Media: Thomas Biegi Vice President Tel: +49 (0)89 / 89927 26079
thomas.biegi@morphosys.com
Kaitlyn Nealy Senior Director Tel: +1 857-283-3945
kaitlyn.nealy@morphosys.com
Investor: Dr. Julia Neugebauer Head of Investor Relations
Tel: +49 (0)89 / 899 27 179 Julia.neugebauer@morphosys.com
Incyte Media: Jenifer
Antonacci Executive Director, Public Affairs Tel: +1 302 498 7036
jantonacci@incyte.com
Investor: Christine Chiou Senior Director, Investor
Relations Tel: +1 302 498 6171 cchiou@incyte.com
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