DGAP-News: MorphoSys AG / Key word(s): Miscellaneous
MorphoSys to Present Data on Tafasitamab at the ASH Virtual Annual Meeting and Exposition
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) today announced that multiple abstracts regarding the company's proprietary key asset tafasitamab have been accepted for poster presentations and online publication at the upcoming 62nd ASH Virtual Annual Meeting and Exposition from December 05-December 08, 2020. Tafasitamab is MorphoSys' CD19-directed antibody which was recently 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).
"We are pleased that pre-clinical data from MorphoSys' research department as well as clinical data from trials investigating our proprietary antibody tafasitamab were selected for presentation at the upcoming virtual ASH Meeting and Exposition," commented Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "Our seven accepted abstracts provide insights into our scientific and clinical activities to evaluate the efficacy and safety of tafasitamab in B-cell lymphoma. They highlight our commitment to unlock the full potential of tafasitamab and continue to broaden the development of our key asset as a therapeutic option for patients with high unmet medical needs."
MorphoSys will host a virtual booth for registered ASH Virtual Annual Meeting and Exposition attendees.
Abstracts accepted for presentation at ASH Virtual Annual Meeting and Exposition include:
LONG-TERM SUBGROUP ANALYSES FROM L-MIND, A PHASE II STUDY OF TAFASITAMAB (MOR208) COMBINED WITH LENALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA
THE COMBINATION OF TAFASITAMAB AND RITUXIMAB INCREASES CYTOTOXICITY AGAINST LYMPHOMA CELLS IN VITRO
BLOCKADE OF THE CD47/SIRPα CHECKPOINT POTENTIATES THE ANTI-TUMOR EFFICACY OF TAFASITAMAB
Abstracts published online:
MAINTAINED CD19 EXPRESSION IN DLBCL PATIENTS AFTER TAFASITAMAB THERAPY IN THE L-MIND STUDY WITHOUT EVIDENCE OF EXON SKIPPING OR SOMATIC MUTATIONS
The abstracts will also be available online in a supplemental issue of Blood. Please refer to the ASH Virtual Annual Meeting and Exposition online program (https://www.hematology.org) for full session details and data presentation listings.
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.
- 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
- Swelling of lower legs or hands
- Respiratory tract infection
- Decreased appetite
These are not all the possible side effects of MONJUVI.
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.
Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com or www.morphosys-us.com.
Monjuvi(R) is a registered trademark of MorphoSys AG.
For more information, please contact:
04.11.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
+49 (0)89 899 27-0
+49 (0)89 899 27-222
Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID:
End of News
DGAP News Service