MEDIA RELEASE
MorphoSys to present MANIFEST and RE-MIND2 data from expanded
hematology-oncology portfolio at the 2021 American Society of
Hematology (ASH) Annual Meeting
- Updates from MANIFEST phase 2 trial in patients with myelofibrosis, including clinical updates on JAK naïve patients treated with pelabresib in combination with ruxolitinib, including translational data
- MANIFEST update on pelabresib monotherapy in patients with myelofibrosis
- Expanded Real-WorldRE-MIND2 dataset comparing outcomes for tafasitamab plus
lenalidomide versus pola-BR, R2, and CAR T in relapsed/refractory diffuse large B-Cell
lymphoma
PLANEGG/MUNICH, Germany - November 4, 2021 - MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that new data on approved and clinical-stage therapeutics will be presented during the American Society of Hematology (ASH) Annual Meeting from December 11-14 in Atlanta, Georgia United States. Ten abstracts were accepted, including two oral presentations, from the comprehensive MorphoSys portfolio, including abstracts for the BET inhibitor pelabresib, which MorphoSys added to its pipeline through the acquisition of Constellation Pharmaceuticals.
"MorphoSys continues to contribute significantly to scientific advances in hematology-oncology with our cancer immunotherapy and our expanded portfolio including the development of epigenetic modifiers," said Malte Peters, MD, MorphoSys Chief Research and Development Officer. "The important data published in our ASH presentations show our commitment to finding cures that redefine how cancer is treated."
The MANIFEST and RE-MIND2 presentations at ASH 2021 are the culmination of a transformational year for MorphoSys. Through groundbreaking proprietary research in immunotherapy and the addition of Constellation Pharmaceuticals' high-potential product candidates, MorphoSys has bolstered its position as an emerging leader in hematology- oncology.
Highlights of presentations from the MorphoSys hematology-oncology portfolio include:
- An update of clinical and translational data from the ongoing MANIFEST trial for JAK naïve patients treated with pelabresib (CPI-0610) in combination with ruxolitinib (study arm 3), representing the analysis for the primary endpoint SVR35
- An update of clinical and translational data from the ongoing MANIFEST trial for pelabresib (CPI-0610) monotherapy in patients with myelofibrosis
- Expanded Real-WorldRE-MIND2 dataset comparing tafasitamab and lenalidomide (Tafa+Len) outcomes to those observed in matched cohorts of 1) polatuzumab vedotin plus bendamustine and rituximab (pola-BR), 2) rituximab plus lenalidomide (R2); and 3) CAR-T therapies
Follow MorphoSys on Twitter via @MorphoSys and visit the MorphoSys ASH virtual booth at www.MorphoSysEvents.com
PELABRESIB ASH 2021 ACCEPTED ABSTRACTS
Study | Abstract Title | Authors | Status / Publication # / |
Session | |||
MANIFEST | Pelabresib (CPI-0610) | Marina Kremyanskaya, | Oral Presentation |
Monotherapy in Patients with | John Mascarenhas, | #141 | |
Myelofibrosis - Update | Francesca Palandri, Alessandro | Session Name: 634. | |
of Clinical and Translational | M. Vannucchi, Srdan Verstovsek, | Myeloproliferative Syndromes: | |
Data from the Ongoing | Claire Harrison, Prithviraj Bose, | Clinical and | |
MANIFEST Trial | Gary J. Schiller, Raajit K. Rampal, | Epidemiological: Non-JAK | |
Mark W. Drummond, Vikas Gupta, | inhibitor Therapies for | ||
Andrea Patriarca, Nikki Granacher, | Myelofibrosis | ||
Joseph Scandura, Witold Prejzner, | Session Date: Saturday, | ||
Lino Teichmann, Natalia Curto- | December 11, 2021 | ||
García, Ronald Hoffman, Gozde | Session Time: 12:00 PM - 1:30 | ||
Colak, Zheng Ren, | PM | ||
Suresh Bobba, Jike Cui, Sergey | Presentation Time: 12:30 PM | ||
Efuni, Moshe Talpaz | Room: Georgia World Congress | ||
Center, A411-A412 | |||
Pelabresib | PK and PD Assessment of | Kristie A. Blum, Jeffrey Supko, | POSTER |
Ph1 | BET Inhibitor Pelabresib (CPI- | Michael Maris, Ian Flinn, Andre | #1202 |
0610) in Patients With | Goy, Anas Younes, Suresh Bobba, | Session Name: 605. Molecular | |
Relapsed or Refractory | Adrian Senderowicz, Sergey | Pharmacology and Drug | |
Lymphoma: Findings from a | Efuni, Ronda Rippley, Jeremy S. | Resistance: | |
Phase 1 Study | Abramson | Lymphoid Neoplasms: Poster I | |
Date: Saturday, December 11, | |||
2021 | |||
Presentation Time: 5:30 PM - | |||
7:30 PM | |||
Location: Georgia World | |||
Congress Center, Hall B5 | |||
MANIFEST | Disease-Modifying Potential of | Srdan Verstovsek, Mohamed E. | Accepted as poster |
BET Inhibitor Pelabresib (CPI- | Salama, John Mascarenhas, | #2568 | |
0610) as Demonstrated by | Moshe Talpaz, Ruben Mesa, | Session Name: 634. | |
Improvements in Bone Marrow Alessandro M. Vannucchi, Raajit K. | Myeloproliferative Syndromes: | ||
Function and Clinical Activity in Rampal, Stephen Oh, | Clinical and | ||
Patients With Myelofibrosis - | Horatiu Olteanu, April Chiu, Dong | Epidemiological: Poster II | |
Preliminary Data | Chen, Curtis A Hanson, | Date: Sunday, December 12, | |
Natalia Curto-García, Pietro | 2021 | ||
Taverna, Jike Cui, | Presentation Time: 6:00 PM - | ||
Oksana Zavidij, Zehua Chen, | 8:00 PM | ||
Gozde Colak, Sergey Efuni, Patricia Location: Georgia World | |||
Keller, Patrick Trojer, Claire | Congress Center, Hall B5 | ||
Harrison |
TAFASITAMAB ASH 2021 ACCEPTED ABSTRACTS
Study | Abstract Title | Authors | Status / Publication # / |
Session | |||
RE-MIND2 | Tafasitamab plus | Grzegorz S. Nowakowski, Dok | Accepted as oral presentation |
Lenalidomide versus pola-BR, | Hyun Yoon, Patrizia Mondello, | #183 | |
R2, and CAR T: Comparing | Erel Joffe, Anthea Peters, | Session Name: 905. Outcomes | |
Outcomes from RE-MIND2, an | Isabelle Fleury, Richard Greil, | Research-Lymphoid | |
Observational, Retrospective | Matthew Ku, Reinhard Marks, | Malignancies: Lymphoma/CLL | |
Cohort Study in | Kibum Kim, Pier Luigi Zinzani, | Real-World Data | |
Relapsed/Refractory Diffuse | Judith Trotman, Lorenzo | Session Date: Saturday, | |
Large B-Cell Lymphoma | Sabatelli, Dan Huang, Eva E. | December 11, 2021 | |
Waltl, Mark Winderlich, Sumeet | Session Time: 12:00 PM - 1:30 | ||
Ambarkhane, Nuwan C. | PM | ||
Kurukulasuriya, Raul Cordoba, | Presentation Time: 12:30 PM | ||
Georg Hess, Gilles Salles | Room: Georgia World Congress | ||
Center, Sidney Marcus | |||
Auditorium | |||
Shared | Preferences and Perceptions | Mallory Yung, Frederick Schnell, | Accepted as poster |
Decision | Regarding Treatment | Mirko Vukcevic, Nuwan C. | (collaboration with Avalere) |
Making in | Decision-Making For | Kurukulasuriya | #1928 |
R/R DLBCL | Relapsed or Refractory | Session Name: 902. Health | |
Diffuse Large B-Cell | Services Research-Lymphoid | ||
Lymphoma (R/R DLBCL) | Malignancies: Poster I | ||
Date: Saturday, December 11, | |||
2021 | |||
Presentation Time: 5:30 PM - | |||
7:30 PM | |||
Location: Georgia World | |||
Congress Center, Hall B5 | |||
inMIND | inMIND: A Phase 3 Study of | Sehn L, Luminari S, Salar A, | Accepted as poster |
(Incyte) | Tafasitamab Plus | Wahlin B, Gopal A, Bonnet C, | Session Name: 623. Mantle |
Lenalidomide and Rituximab | Paneesha S, Trneny M, Manzke | Cell, Follicular, and Other | |
Versus Placebo Plus | O, Seguy F, Li D, Hubel K, | Indolent B Cell Lymphomas: | |
Lenalidomide and Rituximab | Scholz C | Clinical and Epidemiological: | |
for Relapsed/Refractory | Poster II | ||
Follicular or Marginal Zone | Date: Sunday, December 12, | ||
Lymphoma | 2021 | ||
Presentation Time: 6:00 PM - | |||
8:00 PM | |||
Tafasitamab | The SUMOylation Inhibitor | Maria Patra-Kneuer, Akito | Accepted as poster |
+ TAK981 | TAK-981 in Combination with | Nakamura, Keli Song, Stephen | #2268 |
preclinical | the CD19-Targeting Antibody | Grossman, Andrea Polzer, | Session Name: 605. Molecular |
Tafasitamab Shows Enhanced | Carmen Ginzel, Stefan Steidl, | Pharmacology and Drug | |
Anti-Tumor Activity in | Allison J Berger, Igor | Resistance: Lymphoid | |
Preclinical B-Cell Lymphoma | Proscurshim, Christina | Neoplasms: Poster II | |
Models | Heitmüller | Date: Sunday, December 12, | |
2021 | |||
Presentation Time: 6:00 PM - | |||
8:00 PM | |||
Location: Georgia World | |||
Congress Center, Hall B5 |
Tafasitamab | The Impact of Prior Treatment | Reona Sakemura, Claudia | Accepted as poster | ||
+ CAR-T | with a CD19 Targeting | Manriquez Roman, Paulina | (collaboration with Mayo Clinic) | ||
preclinical | Monoclonal Antibody on | Horvei, Ekene Ogbodo, Erin E. | #2412 | ||
Subsequent Treatment with | Tapper,Elizabeth L. Siegler, | Session Name: 622. | |||
CD19 Targeting CART Cell | Carli M. Stewart, Kendall J. | Lymphomas: Translational- | |||
Therapy in Preclinical Models | Schick, Ismail Can, Mohamad | Non-Genetic: Poster II | |||
M. Adada, Evandro D. Bezerra, | Date: Sunday, December 12, | ||||
Lionel Aurelien A. Kankeu | 2021 | ||||
Fonkoua, Mehrdad Hefazi, | Presentation Time: 6:00 PM - | ||||
Michael W. Ruff, Christian | 8:00 PM | ||||
Augsberger, Jürgen Schanzer, | Location: Georgia World | ||||
Maria Patra-Kneuer, Christina | Congress Center, Hall B5 | ||||
Heitmüller, Stefan Steidl, Jan | |||||
Endell, Wei Ding, Sameer A. | |||||
Parikh, Neil E. Kay, Greg | |||||
Nowakowski, Michelle J. Cox, | |||||
Saad S. Kenderian | |||||
First-MIND | First-MIND: Primary Analysis | David Belada, Katerina | Accepted as poster | ||
from a Phase Ib, Open-Label, | Kopeckova, Juan Miguel Bergua | #3556 | |||
Randomized Study to Assess | Burgues, Don Stevens, Marc | Session Name: 626. Aggressive | |||
Safety of Tafasitamab or | André, Ernesto Perez Persona, | Lymphomas: Prospective | |||
Tafasitamab + Lenalidomide in | Petra Pichler, Philipp Staber, | Therapeutic Trials: Poster III | |||
Addition to R-CHOP in | Marek Trneny, Bettina | Date: Monday, December 13, | |||
Patients with Newly | Brackertz, Neha Shah, Andrea | 2021 | |||
Diagnosed Diffuse Large B- | Sporchia, John M. Burke, | Presentation Time: 6:00 PM - | |||
cell Lymphoma | Grzegorz S. Nowakowski | 8:00 PM | |||
Location: Georgia World | |||||
Congress Center, Hall B5 | |||||
First-MIND | Disease kinetics measured by | Mouhamad Khouja, Anke | Accepted as poster with short | ||
MRD | ctDNA correlates with | Schillhabel, Michaela Kotrova, | presentation (collaboration with | ||
Analysis | treatment response after | Nikos Darzentas, Christian | Univ. of Kiel) / #3498 | ||
tafasitamab in combination | Kuffer, Derek Blair, Monika | Session Name: 621. | |||
with R-CHOP with or without | Brüggemann, Christiane Pott | Lymphomas: Translational- | |||
lenalidomide in first line | Molecular and Genetic: Poster | ||||
treatment of DLBCL | III | ||||
Date: Monday, December 13, | |||||
2021 | |||||
Presentation Time: 6:00 PM - | |||||
8:00 PM | |||||
Location: Georgia World | |||||
Congress Center, Hall B5 |
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-dependentcell-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.
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 a therapeutic option in B-cell malignancies in several ongoing combination trials.
Minjuvi® and Monjuvi® 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 the EU.
XmAb® is a registered trademark of Xencor, Inc.
About MANIFEST
MANIFEST is an open-label Phase 2 clinical trial of pelabresib (CPI-0610) in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body's normal production of blood cells. Constellation is evaluating pelabresib in combination with ruxolitinib in JAK-inhibitor-naïve MF patients (Arm 3), with a primary endpoint of the proportion of patients with a ≥35% spleen volume reduction from baseline (SVR35) after 24 weeks of
treatment. Constellation Pharmaceuticals is also evaluating pelabresib either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1), or as add-on therapy in combination with ruxolitinib in patients with a sub-optimal response to ruxolitinib or MF progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on transfusion dependent (TD) status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a ≥35% spleen volume reduction from baseline after 24 weeks of treatment.
About MorphoSys
MorphoSys (FSE & NASDAQ: MOR) is a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody and protein technologies, MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies that are developed by partners in different areas of unmet medical need. In 2017, Tremfya® (guselkumab) - 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 granted accelerated approval of the company's proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit www.morphosys.comor www.morphosys-us.com.
Monjuvi® is a registered trademark of MorphoSys AG.
Tremfya® is a registered trademark of Janssen Biotech, Inc.
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
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MorphoSys AG published this content on 04 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 November 2021 13:14:18 UTC.