MORPHOSYS AG DGAP-News: MorphoSys AG / Key word(s): Miscellaneous MorphoSys to Present Data on Tafasitamab (Monjuvi(R)) at the 2021 ASCO Annual Meeting 2021-05-19 / 23:01 The issuer is solely responsible for the content of this announcement. =---------------------------------------------------------------------------------------------------------------------- Media Release MorphoSys to Present Data on Tafasitamab (Monjuvi^(R)) at the 2021 ASCO Annual Meeting PLANEGG/MUNICH, Germany - May 19, 2021 - MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that new data from the tafasitamab (Monjuvi^(R)) development program will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021. Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which was approved as Monjuvi^(R) (tafasitamab-cxix) in July 2020 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). "We are proud to present important findings from our comprehensive development program for tafasitamab at the ASCO Annual Meeting, including three-year follow-up data from the Phase 2 L-MIND study showing a long durability of responses and overall survival in patients with R/R DLBCL," commented Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "In addition, we will show details from our First-MIND study in front-line DLBCL, indicating our ambition to position Monjuvi as a back-bone strategy in DLBCL and to increase cure rates or duration of remission in DLBCL across all lines of therapy." Abstracts accepted for presentation at the ASCO Annual Meeting include: Poster Discussion LONG-TERM ANALYSES FROM L-MIND, A PHASE 2 STUDY OF TAFASITAMAB (MOR208) COMBINED WITH LENALIDOMIDE (LEN) IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (R/R DLBCL) Abstract Number: 7513 Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia ePosters First-MIND: A PHASE 1B, OPEN-LABEL, RANDOMIZED STUDY TO ASSESS SAFETY OF TAFASITAMAB (TAFA) OR TAFA + LENALIDOMIDE (LEN) IN ADDITION TO R-CHOP IN PATIENTS WITH NEWLY DIAGNOSED DLBCL Abstract Number: 7540 Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAFASITAMAB PLUS LENALIDOMIDE AND RITUXIMAB VERSUS PLACEBO PLUS LENALIDOMIDE AND RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) OR MARGINAL ZONE LYMPHOMA (MZL)^[1] Abstract Number: TPS7568 Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia Please refer to the ASCO online program for full session details and data presentation listings: https:// meetinglibrary.asco.org. All presentations will be available on demand starting June 4, 2021. MorphoSys is looking forward to meeting registered ASCO21 Virtual attendees at its virtual booth accessible through the conference website and through the company's ASCO microsite at www.morphosysevents.com. 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^ (R) 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). Monjuvi^(R) (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^(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States. A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT. Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials. Monjuvi^(R) is a registered trademark of MorphoSys AG. XmAb^(R) 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 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 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 MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage 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 which are developed by partners in different areas of unmet medical need. In 2017, Tremfya^ (R) (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 (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi^(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com. Monjuvi^(R) is a registered trademark of MorphoSys AG. Tremfya^(R) 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, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional
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