MorphoSys to Present New Data on Pelabresib and Monjuvi® (tafasitamab-cxix) at the 2022 European Hematology Association (EHA) and American Society of Clinical Oncology (ASCO) Annual Meetings
MorphoSys AG (NASDAQ: MOR) has announced the presentation of new clinical data on pelabresib and tafasitamab at the EHA 2022 and ASCO 2022 congresses. Key findings from the Phase 2 MANIFEST study will explore pelabresib's efficacy in treating myelofibrosis, a challenging bone marrow cancer, while the RE-MIND2 study will assess tafasitamab's impact on overall survival in relapsed or refractory diffuse large B-cell lymphoma patients. The EHA and ASCO meetings are scheduled from June 3-12, 2022, in Chicago and Vienna, respectively.
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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
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
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
“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
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
|
S198 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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
At
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.
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,
In the
In
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
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
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
Director
Tel: +1 617-548-9271
eamonn.nolan@morphosys.com
Investor Contacts:
Dr.
Senior Director
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
Senior Director
Tel: +1 857-772-0240
myles.clouston@morphosys.com
Source:
FAQ
What is the significance of the data presented by MorphoSys at EHA 2022?
When will MorphoSys present data at ASCO 2022?
What are the key highlights of the RE-MIND2 study related to tafasitamab?
Which congresses will MorphoSys participate in during June 2022?