Efficacy and safety data from the ongoing Phase
2 MANIFEST study of pelabresib in myelofibrosis will be featured
during an oral presentation at the EHA 2022 Hybrid Congress
Translational research that suggests
pelabresib’s potential disease modifying effect in patients living
with myelofibrosis will be shared during an oral presentation at
the EHA 2022 Hybrid Congress
Overall survival data from the observational,
retrospective cohort RE-MIND2 study of tafasitamab in relapsed or
refractory diffuse large B-cell lymphoma will be presented at the
2022 ASCO Annual Meeting
MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced that new data on
pelabresib and tafasitamab, marketed in the U.S. as Monjuvi® and in
Europe as Minjuvi®, will be presented during the 2022 American
Society of Clinical Oncology Annual Meeting (ASCO 2022) in Chicago
from June 3 – 7, 2022 and the 2022 European Hematology Association
Hybrid Congress (EHA 2022) in Vienna, Austria, from June 9 – 12,
2022.
“The data presented at this year’s EHA and ASCO congresses
showcase the breadth, depth and potential of our growing pipeline
of cancer medicines,” said Malte Peters, M.D., MorphoSys Chief
Research and Development Officer. “At EHA 2022, we’re excited to be
presenting the latest results from the ongoing Phase 2 MANIFEST
trial. These data suggest the potential of pelabresib, if approved,
to change the current standard of care in the first-line treatment
of myelofibrosis, a difficult-to-treat bone marrow cancer for which
only limited treatment options are available. Further, at ASCO
2022, we will present new data from the RE-MIND2 study. This trial
is using real world data to investigate the potentially prolonged
survival benefit tafasitamab may offer to patients living with
relapsed or refractory diffuse large B-cell lymphoma, an aggressive
and debilitating disease.”
Highlights from the presentations at EHA 2022 include:
- An oral presentation of clinical data from
the ongoing Phase 2 MANIFEST study investigating pelabresib in
combination with ruxolitinib for the treatment of patients with
myelofibrosis who had not previously been treated with a JAK
inhibitor (JAK inhibitor-naive) and patients with suboptimal
response to ruxolitinib treated with pelabresib in combination with
ruxolitinib (Abstract S198)
- An oral presentation of translational
research from the ongoing Phase 2 MANIFEST study that suggests
pelabresib’s potential disease modifying effect in patients with
myelofibrosis (Abstract S192)
- A poster presentation of data from a
matching-adjusted indirect comparison (MAIC) analysis of pelabresib
in combination with ruxolitinib from the ongoing, Phase 2 MANIFEST
study versus ruxolitinib, fedratinib or momelotinib monotherapy in
patients with intermediate or high-risk myelofibrosis (P1029)
- A poster presentation that outlines the
design and inclusion criteria of the ongoing Phase 3 MANIFEST-2
study, which is exploring the effectiveness and safety of
pelabresib in combination with ruxolitinib in JAK inhibitor-naive
myelofibrosis patients (Abstract P1030)
Highlights from the presentations at ASCO 2022 include:
- A poster presentation of subgroup analyses
of the RE-MIND2 trial, an observational, retrospective cohort study
exploring tafasitamab in combination with lenalidomide versus
systemic therapies in patients with relapsed or refractory diffuse
large B-cell lymphoma, for the primary endpoint, overall survival
(Abstract 7560)
- A poster presentation that spotlights the
progress of the ongoing, randomized Phase 3 frontMIND study, which
is exploring the effectiveness and safety of tafasitamab in
combination with lenalidomide and R-CHOP as a treatment for newly
diagnosed high-intermediate and high-risk diffuse large B-cell
lymphoma (Abstract TPS7590)
EHA 2022 Accepted Abstracts
Abstract Title
Abstract Number
Date/Time
ORAL
BET inhibitor pelabresib (CPI-0610)
combined with ruxolitinib in patients with myelofibrosis — JAK
inhibitor-naive or with suboptimal response to ruxolitinib —
preliminary data from the MANIFEST study
S198
Saturday, June 11, 2022
11:30 a.m. – 12:45 p.m. CEST / 5:30 a.m. –
6:45 a.m. EST
ORAL
Single-cell RNA profiling of myelofibrosis
patients reveals pelabresib-induced decrease of megakaryocytic
progenitors and normalization of CD4+ T cells in peripheral
blood
S192
Saturday, June 11, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. –
11:45 a.m. EST
POSTER
Matching-adjusted indirect comparison
(MAIC) of pelabresib (CPI-0610) in combination with ruxolitinib vs.
ruxolitinib or fedratinib monotherapy in patients with intermediate
or high-risk myelofibrosis
P1029
Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. –
11:45 a.m. EST
POSTER
MANIFEST-2, a global, Phase 3, randomized,
double-blind, active-control study of pelabresib (CPI-0610) and
ruxolitinib vs. placebo and ruxolitinib in JAK-inhibitor-naive
myelofibrosis patients
P1030
Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. –
11:45 a.m. EST
POSTER (Incyte)
inMIND: A Phase 3 study of tafasitamab
plus lenalidomide and rituximab versus placebo plus lenalidomide
and rituximab for relapsed/refractory follicular lymphoma (FL) or
marginal zone lymphoma (MZL)
P1103
Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. –
11:45 a.m. EST
PUBLICATION
frontMIND: A Phase 3, randomized,
double-blind study of tafasitamab + lenalidomide + R-CHOP vs R-CHOP
alone for newly diagnosed high-intermediate and high-risk diffuse
large B-cell lymphoma
PB2113
N/A
PUBLICATION
Pharmacokinetics and pharmacodynamics in
firstMIND: A Phase 1B, open-label, randomized study of tafasitamab
± lenalidomide + R-CHOP in patients with newly diagnosed diffuse
large B-cell lymphoma
PB2110
N/A
PUBLICATION
MINDway: A Phase 1B/II dose optimization
study to assess safety and pharmacokinetics of tafasitamab +
lenalidomide in patients with relapsed/refractory diffuse large
B-cell lymphoma
PB2112
N/A
PUBLICATION
realMIND: A prospective, multicenter,
observational study of patients with relapsed/refractory diffuse
large B-cell lymphoma starting second/third-line therapy and not
receiving a stem cell transplant
PB2109
N/A
PUBLICATION
Subgroup analysis in RE-MIND2, an
observational, retrospective cohort study of tafasitamab +
lenalidomide versus systemic therapies in patients with
relapsed/refractory diffuse large B-cell lymphoma
PB2111
N/A
ASCO 2022 Accepted Abstracts
Abstract Title
Abstract Number
Date/Time
POSTER
Subgroup analysis in RE-MIND2, an
observational, retrospective cohort study of tafasitamab plus
lenalidomide versus systemic therapies in patients with
relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL)
7560
Saturday, June 4
3:00 p.m. CEST / 9:00 a.m. EST
POSTER
frontMIND: A Phase 3, randomized,
double-blind study of tafasitamab + lenalidomide + R-CHOP versus
R-CHOP alone for newly diagnosed high-intermediate and high-risk
diffuse large B-cell lymphoma.
TPS7590
Saturday, June 4, 2022
3:00 p.m. CEST / 9:00 a.m. EST
POSTER (Incyte)
inMIND: A Phase 3 study of tafasitamab
plus lenalidomide and rituximab versus placebo plus lenalidomide
and rituximab for relapsed/refractory follicular or marginal zone
lymphoma
TPS7583
Saturday, June 4, 2022
3:00 p.m. CEST / 9:00 a.m. EST
PUBLICATION
Pharmacokinetics (PK) and pharmacodynamics
(PD) in First-MIND: a phase Ib, open-label, randomized study of
tafasitamab (tafa) ± lenalidomide (LEN) in addition to R‑CHOP in
patients (pts) with newly diagnosed diffuse large B-cell lymphoma
(DLBCL)
e19553
N/A
PUBLICATION
Preferences and Perceptions Regarding
Treatment Decision-Making For Relapsed or Refractory Diffuse Large
B-Cell Lymphoma (R/R DLBCL)
e18710
N/A
Please refer to the EHA (https://learningcenter.ehaweb.org/eha)
and ASCO (https://meetinglibrary.asco.org) online programs for full
session details and data presentation listings.
About MorphoSys At MorphoSys, we are driven by our
mission to give more life for people with cancer. As a global
commercial-stage biopharmaceutical company, we use groundbreaking
science and technologies to discover, develop, and deliver
innovative cancer medicines to patients. 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 Pelabresib Pelabresib (CPI-0610) is an
investigational selective small-molecule designed to promote
anti-tumor activity by inhibiting the function of bromodomain and
extra-terminal domain (BET) proteins to decrease the expression of
abnormally expressed genes in cancer.
MorphoSys is currently recruiting for the MANIFEST-2 study
(NCT04603495). This study is a global, double-blind, randomized
Phase 3 clinical trial with pelabresib in combination with
ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naive
patients with myelofibrosis. The primary endpoint of the study is a
≥35% reduction in spleen volume (SVR35) from baseline at 24 weeks.
A key secondary endpoint of the study is 50% or greater improvement
in Total Symptom Score (TSS50) from baseline at 24 weeks.
Pelabresib is currently being investigated as a treatment for
myelofibrosis and has not yet been evaluated or approved by any
regulatory authorities.
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 U.S., 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
approval, 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 an
immunotherapeutic 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, the UK 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 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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220512005613/en/
For more information, please contact:
Media Contacts: Thomas Biegi Vice President Tel.: +49
(0)89 / 89927 26079 thomas.biegi@morphosys.com
Eamonn Nolan Director Tel: +1 617-548-9271
eamonn.nolan@morphosys.com
Investor Contacts: Dr. Julia Neugebauer Senior Director
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
Myles Clouston Senior Director Tel: +1 857-772-0240
myles.clouston@morphosys.com
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