MORPHOSYS AG

MOR
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PRESS RELEASE: MorphoSys and Incyte Announce First Patient Dosed in Phase 3 inMIND Study Evaluating the Addition of Tafasitamab to Lenalidomide and Rituximab in Relapsed or Refractory FL or MZL

04/19/2021 | 04:02pm
DGAP-News: MorphoSys AG / Key word(s): Miscellaneous 
MorphoSys and Incyte Announce First Patient Dosed in Phase 3 inMIND Study Evaluating the Addition of Tafasitamab to 
Lenalidomide and Rituximab in Relapsed or Refractory FL or MZL 
2021-04-19 / 22:01 
The issuer is solely responsible for the content of this announcement. 
=---------------------------------------------------------------------------------------------------------------------- 
Press release 
MorphoSys and Incyte Announce First Patient Dosed in Phase 3 inMIND Study Evaluating the Addition of Tafasitamab to 
Lenalidomide and Rituximab in Relapsed or Refractory Follicular or Marginal Zone Lymphoma 
PLANEGG/MUNICH, Germany and WILMINGTON, Del. - April 19, 2021 - MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & 
TecDAX; NASDAQ: MOR) and Incyte (NASDAQ: INCY) today announced the first patient has been dosed in the 
placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination 
with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone 
lymphoma (MZL). 
"Despite improvements in treatment for patients with relapsed or refractory FL and MZL, there continues to be a 
significant medical need for additional therapies with improved outcomes," said Peter Langmuir, M.D., Group Vice 
President, Oncology Targeted Therapeutics, Incyte. "We are pleased to have initiated the inMIND study as we seek 
meaningful, new options for patients with relapsed or refractory FL or MZL." 
FL and MZL are the most common indolent, or slow growing, forms of B-Cell non-Hodgkin lymphomas (NHLs). FL and MZL 
account for approximately 20-25% and 7% of adult NHL cases, respectively.^[1] There are limited treatment options for 
the more than 17,000 new cases of relapsed or refractory FL treated every year in the United States, Europe and Japan.^ 
[2] 
"We are looking forward to building on previous, exploratory data in FL, and the results seen with tafasitamab and 
lenalidomide in relapsed or refractory diffuse large B-cell lymphoma, to evaluate the potential benefit of adding 
tafasitamab to the current lenalidomide and rituximab combination regimen in patients with indolent lymphomas," said 
Mike Akimov, M.D., Ph.D., Head of Global Drug Development, MorphoSys. 
On January 7, 2021, the U.S. Food and Drug Administration granted orphan drug designation for tafasitamab for the 
treatment of FL. 
About inMIND 
inMIND (NCT04680052), a global, double-blind, placebo-controlled, randomized Phase 3 study, is evaluating whether 
tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide 
alone as an add-on to rituximab in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or 
relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study is expected to enroll over 
600 adult (age >=18 years) patients with relapsed or refractory FL or MZL. 
The primary endpoint of the study is progression-free survival (PFS) in the FL population, and the key secondary 
endpoints are PFS and overall survival (OS) in the overall population as well as positron emission tomography complete 
response (PET-CR) at the end of treatment (EOT) in the FL population. 
For more information about the study, please visit: https://clinicaltrials.gov/ct2/show/NCT04680052 
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 patients suffering from cancer and autoimmune diseases. Based on its 
leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed 
and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical 
development. In 2017, Tremfya^(R), 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. 
About Incyte 
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet 
medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional 
information on Incyte, please visit Incyte.com and follow @Incyte. 
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 

(MORE TO FOLLOW) Dow Jones Newswires

April 19, 2021 16:01 ET (20:01 GMT)

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