WILMINGTON, Del. & PLANEGG, Germany & MUNICH--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi (tafasitamab) 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). The EC decision follows the positive opinion received from the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending the conditional marketing authorization of Minjuvi.
People living with relapsed or refractory DLBCL in the EU, have historically had limited treatment options and a poor prognosis. However, with the ECs approval of Minjuvi, eligible patients now have a new and much needed treatment option, said Herv Hoppenot, Chief Executive Officer, Incyte. We will now focus our efforts on working with individual countries in Europe to provide people access to this new treatment.
The approval of Minjuvi is a crucial milestone for patients with relapsed or refractory DLBCL in Europe, said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. DLBCL is the most common type of non-Hodgkin lymphoma in adults and Minjuvi addresses an urgent unmet medical need for the 30-40% of people who do not respond to or relapse, after initial therapy.
The conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 43.9 months after a minimum follow up of 35 months (secondary endpoint). Minjuvi together with lenalidomide was shown to provide a clinically meaningful response and the side effects were manageable. Warnings and precautions for Minjuvi include infusion-related reactions, myelosuppression, including neutropenia and thrombocytopenia, infections and tumour lysis syndrome.
The data from the L-MIND study demonstrate the potential benefits, including long duration of response, that tafasitamab may have for eligible DLBCL patients, said Professor Pier Luigi Zinzani M.D., Ph.D., Head of the Lymphoma Group at University of Bologna. It is encouraging to see new treatments become available for these patients, especially given the historical lack of treatment options in this area.
Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and is marketed by Incyte under the brand name Minjuvi in the EU.
About Diffuse Large B-Cell LymphomaDLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases4, and is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs5. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter6. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL7,8,9.
About L-MINDThe L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HDC) or autologous stem cell transplant (ASCT). The studys primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.
For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.
About Minjuvi (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-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, 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 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 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.
Safety Information from the EU Summary of Product Characteristics (SmPC)Infusion-related reactions may occur and have been reported more frequently during the first infusion. Patients should be monitored closely throughout the infusion and should be advised to contact their healthcare professionals if they experience signs and symptoms of infusion related reactions including fever, chills, rash or breathing problems within 24 hours of infusion. A premedication should be administered to patients prior to starting tafasitamab infusion. Based on the severity of the infusion-related reaction, tafasitamab infusion should be interrupted or discontinued and appropriate medical management should be instituted.
Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with Minjuvi.
Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops.
Treatment with Minjuvi in combination with lenalidomide should not be initiated in female patients unless pregnancy has been excluded.
The most common adverse reactions were infections, neutropenia, asthenia, anemia, diarrhea, thrombocytopenia, cough, oedema peripheral, pyrexia and decreased appetite.
Minjuvi may cause serious adverse reactions. The most common serious adverse reactions were infection, including pneumonia and febrile neutropenia.
Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia and anemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.
About IncyteIncyte 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.
About MorphoSysMorphoSys (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 (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 the companys proprietary product Monjuvi (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. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit http://www.morphosys.com or http://www.morphosys-us.com.
Tremfya is a registered trademark of Janssen Biotech, Inc.
Incyte Forward-looking StatementsExcept for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Companys expectations relating to the use of tafasitamab for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the Companys ongoing clinical development program for tafasitamab, and its DLBCL program generally, contain predictions, estimates, and other forward-looking statements.
These forward-looking statements are based on the Companys current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Companys clinical trials, supply chain, and other third-party providers and development and discovery operations; determinations made by the European Commission and other regulatory authorities; the Companys dependence on its relationships with its collaboration partners; the efficacy or safety of the Companys products and the products of the Companys collaboration partners; the acceptance of the Companys products and the products of the Companys collaboration partners in the marketplace; market competition; sales, marketing, manufacturing, and distribution requirements; and other risks detailed from time to time in the Companys reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
MorphoSys Forward-looking StatementsThis 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 not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
_____________________1 DRG Epidemiology data.2 Kantar Market Research (TPP testing 2018).3 Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.4 Cancer Research UK. Diffuse large B cell lymphoma. Available at https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma. Accessed: May 2021.5 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:20916. doi.org/10.1016/j.beha.2018.07.014.6 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253265. doi.org/10.3747/co.26.5421.7 DRG Epidemiology data.8 Kantar Market Research (TPP testing 2018).9 Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.
Originally posted here:
- COVID-19: Researchers warn against overhyping early-stage therapies - Medical News Today - October 26th, 2021
- OpRegen Data Update to Be Featured at 2021 American Academy of Ophthalmology Annual Meeting in Presentation by Michael S. Ip, M.D. - Yahoo Finance - October 26th, 2021
- Insights & Outcomes: Place cells, planarians, and 'prewet' proteins - Yale News - October 26th, 2021
- IMAC Holdings The Back Space Announces the Completion of Two Additional Retail Spinal Care Locations - Yahoo Finance - October 26th, 2021
- JEFFERSON PARISH PARTNERS WITH LOUISIANA DEPARTMENT OF HEALTH TO ADMINISTER FREE FLU SHOTS AND COVID-19 VACCINES ON NOVEMBER 6, 2021 - 10-25-YYYY -... - October 26th, 2021
- Male Infertility Could Be Treated With Monkey Cells; New Study Shows How These Animals Could Help Address the Condition - Science Times - October 26th, 2021
- Citius Pharmaceuticals to Host Key Opinion Leader Webcast on the Compelling Need to Salvage Central Venous Catheters in CLABSI Patients - Yahoo... - October 26th, 2021
- New findings may help widen therapeutic interventions for B-cell acute lymphoblastic leukemia - News-Medical.Net - October 25th, 2021
- Getting to Know Kate Roth at Beacon Integrative Medical Center in Rexburg - East Idaho News - October 25th, 2021
- Global Cell Therapy Market Report 2021-2028 - Growing Adoption of Regenerative Medicine & Introduction of Novel Platforms and Technologies -... - October 25th, 2021
- Vertex reports positive results for first patient in Type 1 diabetes trial - BetaBoston - October 23rd, 2021
- Morris receives grant for stem cell research - The Source - Washington University Record - October 23rd, 2021
- Vertex moves ahead with its bid to develop a curative treatment for type 1 diabetes - PMLiVE - October 23rd, 2021
- McLaughlin Research Institute receives $5 million gift to support neurology studies - Great Falls Tribune - October 23rd, 2021
- AML medication and treatment: What to know - Medical News Today - October 23rd, 2021
- U S Stem Cell : USRM to Focus on Animal Health and Lead Pet-Care Innovation - Marketscreener.com - October 19th, 2021
- Opinion: Why Colin Powell's death should not be framed as the death of a vaccinated person - Poynter - October 19th, 2021
- Quris combines AI with patient on a chip to speed drug development and reduce animal testing - TechCrunch - October 19th, 2021
- Dr. Helen Heslop elected to the National Academy of Medicine - Baylor College of Medicine News - October 19th, 2021
- Researchers report long-lasting effects of gene therapy in children with deadly immune disorder - News-Medical.Net - October 19th, 2021
- Coronavirus: How does misinformation spread, and how can we stop it? - The Jerusalem Post - October 17th, 2021
- Dr. Kahl on the Potential Utility of Frontline CAR T-Cell Therapy in MCL - OncLive - October 17th, 2021
- FDA Approves Genentech's Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer - Business Wire - October 17th, 2021
- Global Stem Cell and Primary Cell Culture Medium Market 2021 Trends and Leading Players Analysis 2027 Merck, STEMCELL Technologies, Irvinesci, Cell... - October 15th, 2021
- Dr. Erba on the Evolution of Treatment in MCL - OncLive - October 15th, 2021
- After no stem cell donors stepped up to saved her son, mom continues to help others facing the same challenge - Chicago Tribune - October 15th, 2021
- International ZIM Network: SmartMed - Regenerative Solutions for the Therapies of Tomorrow - Business Wire - October 15th, 2021
- Are 'robot massages' the future of muscle repair? - Medical News Today - October 15th, 2021
- What the FDA Panel's Moderna Booster Shot Vote Means and What's Next - NBC Chicago - October 15th, 2021
- Phase 2 Clinical Trial Data of NurOwn in Progressive MS Will Be Presented at the 37th Congress of the European Committee for Treatment and Research in... - October 15th, 2021
- R3 Stem Cell & Exosome Therapy: Joint & Back Pain, Avoid ... - October 13th, 2021
- Stem Cell PhD Program | Institute for Stem Cell Biology ... - October 13th, 2021
- New stem cell identified by Sanford Burnham Prebys researchers offers hope to people with rare liver disease - Newswise - October 13th, 2021
- Repurposed Drug Reverses Signs of Alzheimers in Mice, Human Cells - The Scientist - October 13th, 2021
- Bone Therapeutics appoints Scientific Advisory Board for iMSC cell and gene therapy platform development - StreetInsider.com - October 13th, 2021
- What the latest COVID research says about breakthrough cases and transmission : Shots - Health News - NPR - October 13th, 2021
- HNF collaborates with Rarebase on a Drug Discovery Platform to develop treatments for Charcot-Marie-Tooth (CMT) - PRNewswire - October 13th, 2021
- Autologous HSCT Continues to Show Sustained Benefit in MCL, But Targeted Therapies May Challenge its Role as Standard Frontline Treatment -... - October 13th, 2021
- Bartolo Coln, Winner Of The Cy Young, Wins Lawsuit In Case Of Stem Cell Treatment To Which He Was Subjected Before His Return To The Major Leagues. -... - October 11th, 2021
- The Impact Of Market Restrictions On The US Stem Cell Biomaterials Market - Med Device Online - October 11th, 2021
- Vitro Biopharma Inc. July 31st 2021; 3rd Quarter ended Financial Results of Operations and Shareholder Letter. - Yahoo Finance - October 11th, 2021
- Top US Leukemia Experts from Academia, Industry and Public Sector Coming Together at Acute Myeloid Leukemia Conference on October 22 - OncLive - October 11th, 2021
- Precision medicine data dive shows water pill may be viable to test as Alzheimer's treatment - National Institutes of Health - October 11th, 2021
- Treating Early Relapse in Follicular Lymphoma - Targeted Oncology - October 11th, 2021
- Humans and Chimpanzees Use a Part of Their DNA in Different Ways - Technology Networks - October 11th, 2021
- A stem cell treatment for MS offers some patients hope. But is it hope that will last? - WHYY - October 9th, 2021
- CAR T Offer New Treatment Option for Non-Hodgkin Lymphoma - Targeted Oncology - October 9th, 2021
- FDA Advisory Committee Recommends Maribavir to Treat Cytomegalovirus CMV Infection and Disease - Contagionlive.com - October 9th, 2021
- What surgeons are saying about regenerative medicine in 2021 - Becker's Orthopedic & Spine - October 9th, 2021
- Study illuminates how BRD4 protein directs the spatial organization of DNA within cell nucleus - News-Medical.net - October 9th, 2021
- Cellular Therapy Strategies Offer the Prospect of Deep Remissions for Multiple Myeloma - OncLive - October 9th, 2021
- Anti-CD47 Therapy and Other New Approaches to the Treatment of Myelodysplastic - Targeted Oncology - October 9th, 2021
- ViaCyte to Present at Alliance for Regenerative Medicine Cell & Gene Meeting on the Mesa - PRNewswire - October 7th, 2021
- Seattle Stem Cell Therapy Clinic - Seattle Sports Medicine ... - October 7th, 2021
- StemExpress Partners with the Alliance for Regenerative Medicine to Provide COVID-19 Testing for the Cell and Gene Meeting on the Mesa - PRNewswire - October 7th, 2021
- New Stem Cell Approach Through Using Wavelength Laser Might have Discovered Why Humans Lose Hair - Tech Times - October 5th, 2021
- Faster healing of wounds can decrease pain and suffering and save lives - WMTV - NBC15 - October 5th, 2021
- Losing Your Hair? You Might Blame the Great Stem Cell Escape. - The New York Times - October 5th, 2021
- Northwesterns SPORE has made advances in understanding the genetic basis of glioblastoma - News-Medical.Net - October 5th, 2021
- NextCure Announces New Appointments to its Board of Directors - GlobeNewswire - October 5th, 2021
- Therapy and Prevention Strategies for Myocardial Infarction | IJN - Dove Medical Press - October 3rd, 2021
- Lack of awareness about blood stem cell donation is one of the leading causes for low number of donors in In.. - ETHealthworld.com - October 3rd, 2021
- Advanced technique offers new insights about the dynamics of gliomas - News-Medical.net - October 3rd, 2021
- "Stem cell-based therapeutics poised to become mainstream option - BSA bureau - October 2nd, 2021
- The stem cell revolution isnt what you think it is - New Scientist News - October 2nd, 2021
- Stem cell agency gives out $2 million a minute - Capitol Weekly - October 2nd, 2021
- Researching the Safety and Effectiveness of Stem Cells to Treat 'Long Covid' - Entrepreneur - October 2nd, 2021
- United States Regenerative Medicine Markets to 2026: Focus on Cell Therapies, Gene Therapies, Progenitor & Stem Cell Therapies, Tissue Engineered... - October 2nd, 2021
- U.S. FDA Approves Kite's Tecartus as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia - Business... - October 2nd, 2021
- Omeros Provides Regulatory Update on Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA - Business Wire - October 2nd, 2021
- Stem Cell Umbilical Cord Blood Market in North America 2021 Sees Growth Due to Rising Spending Capacity and Suitable Payment Plans - PRNewswire - October 2nd, 2021
- BrainStorm to Present Phase 2 Progressive MS Study Results in Oral Presentation at 37th Congress of ECTRIMS - BioSpace - October 2nd, 2021
- Macomics Announces New Hires that Expands its Macrophage-based Drug Discovery R&D Team - BioSpace - October 2nd, 2021
- Stanford neuroscientist's 'assembloids' pave the way for innovative brain research - Scope - October 2nd, 2021
- At the crossroads of reproductive and regenerative medicine: new opportunities for preserving and restoring fertility - ESHRE - September 25th, 2021
- Doctors Debate: Do CAR T Cells and Transplantation Both Have a Place in Aggressive B-Cell Lymphoma Treatment? - Targeted Oncology - September 25th, 2021
- Global Stem Cell Alopecia Treatment Market 2021 Development Status,Industry Insights and Forecast Research Report 2027 Stillwater Current -... - September 25th, 2021
- AML vs. ALL: Differences in symptoms, diagnosis, and survival - Medical News Today - September 25th, 2021
- New gene therapies may soon treat dozens of rare diseases - American Society for Biochemistry and Molecular Biology - September 25th, 2021
- BioRestorative Therapies Receives Notice of Allowance for Patent Application in Israel for its Metabolic Program - GlobeNewswire - September 25th, 2021