Business Wire

Darzalex ®▼ (daratumumab) Phase 3 Study Shows Efficacy and Safety Data of Anti-CD38 Monoclonal Antibody in Patients with Newly Diagnosed Multiple Myeloma

Jaa

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 3 MAIA study demonstrating that the addition of daratumumab to lenalidomide and dexamethasone (Rd) significantly reduced the risk of disease progression or death in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Abstract #LBA-2).1 These data were featured during the late-breaking abstract (LBA) oral session at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, CA.

“The Phase 3 MAIA study reinforces the clinical profile of daratumumab in combination with a standard of care treatment regimen for newly diagnosed patients with multiple myeloma who are transplant ineligible,” said Thierry Facon, M.D., Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, and principal investigator. “The positive data show the potential role of daratumumab in combination with lenalidomide and dexamethasone as an important new therapeutic approach for this patient population.”

At a median follow-up of 28 months, data from the Phase 3 MAIA study showed daratumumab in combination with Rd significantly reduced the risk of disease progression or death by 44 percent in patients with newly diagnosed multiple myeloma who are transplant ineligible compared to treatment with Rd alone (Hazard Ratio [HR] = 0.56; 95 percent confidence interval [CI]: 0.43-0.73; p<0.0001).1 The median progression-free survival (PFS) for daratumumab-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone.1 The addition of daratumumab resulted in deeper responses compared to Rd alone, including increased rates of complete response (CR) or better (48 percent vs. 25 percent) and improved rates of very good partial response (VGPR) or better (79 percent vs. 53 percent).1 Daratumumab-Rd induced a >3-fold higher rate of minimal residual disease (MRD) negativity compared to those who received Rd alone (24 percent vs. 7 percent).1

“These data underscore the consistent clinical profile observed among newly diagnosed patients with multiple myeloma receiving daratumumab therapy, including for those who are transplant ineligible,” said Dr Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. “This is the third study in newly diagnosed patients that has met its primary endpoint and we hope to continue delivering innovative advances to patients with multiple myeloma through our robust clinical research programme, which has the potential to revolutionise cancer treatment by arresting the disease at its earliest stages.”

The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for daratumumab-Rd (≥10 percent) included neutropenia (50 percent), lymphopenia (15 percent), pneumonia (14 percent) and anaemia (12 percent).1 Infusion-related reactions (IRRs) occurred in 41 percent of patients, only 3 percent of which were Grade 3/4.1 Incidence of invasive second primary malignancy was 3 percent in the daratumumab-Rd arm compared to 4 percent with Rd alone.1 TEAEs with an outcome of death were 7 percent in the daratumumab-Rd arm compared to 6 percent in the Rd arm.1 The safety profile of daratumumab was consistent with that of previous studies.1

These data will support a future application for marketing authorisation for daratumumab in combination with Rd for this patient population.

#ENDS#

About the MAIA Trial 1

The randomised, open-label, multicentre Phase 3 study included 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45-90 years old (median age of 73). Patients were randomised to receive either daratumumab-Rd or Rd alone in 28-day Cycles. In the daratumumab-Rd treatment arm, patients received daratumumab 16 milligrams per kilogram (mg/kg) IV weekly for Cycles 1 – 2, every two weeks for Cycles 3 – 6 and every 4 weeks for Cycle 7 and thereafter. Patients in the daratumumab-Rd and Rd treatment arm received 25 mg of lenalidomide on Days 1 – 21 of each 28-day Cycle, and dexamethasone at 40 mg once a week for each Cycle. Patients in both treatment arms continued until disease progression or unacceptable toxicity.

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.2 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.3 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.3 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.4,5,6,7,8,9,10,11 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.12,13 For more information, please see www.clinicaltrials.gov.

In Europe, daratumumab is indicated for use in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy, and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.3 For further information on daratumumab, please see the Summary of Product Characteristics at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004077/WC500207296.pdf.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.14

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.15 More than 45,000 people were diagnosed with multiple myeloma in Europe in 2016, and more than 29,000 patients died.16 Up to half of newly diagnosed patients do not reach five-year survival,17 and almost 29% of patients with multiple myeloma will die within one year of diagnosis.18

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.19 Refractory multiple myeloma is when a patient’s disease progresses within 60 days of their last therapy.20,21 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.22 While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.23 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.24

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news.

Cilag GmbH International; Janssen Biotech, Inc.; Janssen Oncology, Inc. and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

# # #

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the benefits of daratumumab for the treatment of patients with multiple myeloma. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and of Janssen-Cilag International NV, Janssen-Cilag Limited, Janssen Biotech, Inc., any of the Janssen Pharmaceutical Companies of Johnson & Johnson and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Reports on Form 10-Q and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies of Johnson & Johnson nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References

1 Facon T, Kumar SJ, Plesner T, et al. Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA). Presented at the 60th Annual Meeting and Exposition of the American Society of Hematology, San Diego, CA, USA, 1-4 December 2018: Oral presentation.

2 Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm. 2013;2013:564687.

3 Darzalex summary of product characteristics, October 2018. Available at: https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf Last accessed November 2018.

4 ClinicalTrials.gov. A study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma. NCT02076009. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009 Last accessed November 2018.

5 ClinicalTrials.gov. Addition of daratumumab to combination of bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma. NCT02136134. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134 Last accessed November 2018.

6 ClinicalTrials.gov. A study to evaluate daratumumab in transplant eligible participants with previously untreated multiple myeloma (Cassiopeia). NCT02541383. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383 Last accessed November 2018.

7 ClinicalTrials.gov. A study of combination of daratumumab and Velcade (bortezomib) melphalan-prednisone (DVMP) compared to Velcade melphalan-prednisone (VMP) in participants with previously untreated multiple myeloma. NCT02195479. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479 Last accessed November 2018.

8 ClinicalTrials.gov. Study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in participants with previously untreated multiple myeloma. NCT02252172. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172 Last accessed November 2018.

9 ClinicalTrials.gov. A study of Velcade (bortezomib) melphalan-prednisone (VMP) compared to daratumumab in combination with VMP (D-VMP), in participants with previously untreated multiple myeloma who are ineligible for high-dose therapy (Asia Pacific region). NCT03217812. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812 Last accessed November 2018.

10 ClinicalTrials.gov. Comparison of pomalidomide and dexamethasone with or without daratumumab in subjects with relapsed or refractory multiple myeloma previously treated with lenalidomide and a proteasome inhibitor daratumumab/pomalidomide/dexamethasone vs pomalidomide/dexamethasone (EMN14). NCT03180736. Available at: https://clinicaltrials.gov/ct2/show/NCT03180736 Last accessed November 2018.

11 ClinicalTrials.gov. Study of carfilzomib, daratumumab and dexamethasone for patients with relapsed and/or refractory multiple myeloma (CANDOR). NCT03158688. Available at: https://clinicaltrials.gov/ct2/show/NCT03158688 Last accessed November 2018.

12 ClinicalTrials.gov. A study to evaluate 3 dose schedules of daratumumab in participants with smoldering multiple myeloma. NCT02316106. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106 Last accessed November 2018.

13 ClinicalTrials.gov. An efficacy and safety proof of concept study of daratumumab in relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma. NCT02413489. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489 Last accessed November 2018.

14 Johnson & Johnson. Janssen Biotech announces global license and development agreement for investigational anti-cancer agent daratumumab. Press release August 20, 2012. Available at: http://www.investor.jnj.com/releaseDetail.cfm?releaseid=703517 Last accessed November 2018.

15 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction Last accessed November 2018.

16 Cowan AJ, Allen C, Barac A, et al. Global burden of multiple myeloma: a systematic analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018;4:1221-1227 + data supplement.

17 De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68.

18 Costa LJ, Gonsalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia. 2015;29:1616-8.

19 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–207.

20 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245 Last accessed November 2018.

21 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.

22 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866 Last accessed November 2018.

23 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf Last accessed November 2018.

24 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.


PHEM/DAR/1118/0010
December 2018

Contact information

Media Enquiries:
Natalie Buhl
Mobile: +353 (0)85-744-6696
Email: nbuhl@its.jnj.com

Investor Relations:
Christopher DelOrefice
Phone: +1 732-524-2955

Lesley Fishman
Phone: +1 732-524-3922

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Enamine Extends Multi-Year Drug Discovery Collaboration with Lundbeck26.3.2019 12:17:00 EETTiedote

Enamine Ltd. a provider of integrated drug discovery services empowered by the world’s largest collections of building blocks and screening compounds, and H. Lundbeck A/S (Lundbeck), the global pharmaceutical company involved in the research of new drugs for the treatment of disorders in the central nervous system, today announced the expansion of their research collaboration. Enamine will support Lundbeck’s in-house discovery chemistry competencies with three principal assets enabling Lundbeck to optimally identify and develop hit series in its multiple research programs. A large diverse library of 100,000 new screening compounds for hit finding activities on numerous therapeutic targets. Enamine’s make-on-demand REAL compounds (Nature, 2019, Vol. 566, p. 224–229) for efficient access to billions of novel chemical compounds. An increased dedicated team of Enamine FTE chemists to effectively support Lundbeck on all hit related follow-up activities backed by immediate access to over 170

Acuris Risk Intelligence launches Acuris Cybercheck26.3.2019 12:00:00 EETTiedote

Acuris Risk Intelligence, a trusted and independent provider of data intelligence for anti-money laundering, anti-corruption and cyber security professionals, today announces the launch of Acuris Cybercheck, a database that allows businesses and individuals to identify whether or not their information has been compromised by criminals. Acuris Cybercheck provides the largest proprietary database of compromised personal ID data. Complied since 2008, the database includes information traded on criminal websites globally such as identity, personal and financial data. It also allows users to search via APIs against specific records or to continuously monitor data. The database is a one-stop shop for monitoring compromised data, allowing users to, among other things, proactively monitor personal data and receive alerts, mitigate identified risks, improve GDPR compliance, provide evidence of potential data breach and assess data compromise in M&A and corporate transactions. The system uses sk

GlobalLogic Appoints Veteran CEO Björn Ivroth as Board Advisor26.3.2019 11:00:00 EETTiedote

GlobalLogic Inc., a leader in digital product engineering, today announced that, effective immediately, Björn Ivroth joins the company as an advisor to its Board of Directors. Mr. Ivroth recently served as the CEO of EVRY, a leading Nordic IT services and software provider. In this role, he will work alongside the Board, the CEO, and fellow accomplished leaders contributing to the development and execution of growth strategies driving GlobalLogic’s European business. “We are thrilled to have someone of Björn’s caliber as part of our advisory team,” said Shashank Samant, CEO, GlobalLogic. “His experience as an operating leader, and deep knowledge of the European market are tremendous assets to GlobalLogic, and we are looking forward to leveraging his expertise as we continue to expand our European footprint.” Mr. Ivroth started his career as a Management Consultant at McKinsey & Company. Other early experiences include leadership roles focused on IT Services at Accenture and IBM. His ca

European MSPs Could Lose SMB Clients Over Cybersecurity: Vanson Bourne Report26.3.2019 11:00:00 EETTiedote

Cybersecurity demands of small- and medium-sized businesses (SMBs) have become both a major risk and revenue opportunity to managed service providers (MSPs). This is according to research conducted by Vanson Bourne and commissioned by Continuum ®, the proactive platform that integrates intelligent software with expert services for MSPs to scale dynamically and protect their clients. Underserved and Unprepared: The State of SMB Cyber Security in 2019, released today, draws on data collected in 2019 from 850 SMBs across the United States, United Kingdom, France, Germany and Belgium. In addition to the risks for MSPs, the report also highlights the significant revenue opportunity for providers that deliver the cybersecurity services and solutions SMBs need to protect their businesses. Vanson Bourne’s research in the four European countries found that MSPs are at risk of losing their SMB clients over cybersecurity concerns. More than nine in ten (93 percent) SMBs would consider hiring a ne

Evaluate Ltd. Appoints Deborah Kobewka as Chief Executive Officer26.3.2019 11:00:00 EETTiedote

Evaluate Ltd., the leading provider of commercial data to the life sciences industry, is pleased to announce the appointment of Deborah Kobewka as Chief Executive Officer, effective immediately. Deborah succeeds Alex Karle, who joined Evaluate in 2012 as Chief Operating Officer before assuming the role of CEO in 2014. Deborah brings to Evaluate over 30 years of expertise in the global pharmaceutical, healthcare and information sectors. With her successful track record of driving commercial expansion, she is well positioned to accelerate the company’s current growth trajectory. Deborah joins Evaluate from the Department for International Trade in the UK government where she served as Managing Director of Healthcare UK, Lifesciences and Bio-economy. Prior to that, she held senior corporate and operational roles at both private and government organisations in the UK, Europe and Asia, including 24 years at IMS Health (now IQVIA). “Evaluate has an impressive history of pioneering solutions

Illumina and the Lundbeck Foundation GeoGenetics Centre Collaborate to Generate One of the Largest Ancient Genome Datasets to Decode the Genetic Origins and Evolution of Mental Health Issues26.3.2019 09:00:00 EETTiedote

Illumina (NASDAQ:ILMN) and the Lundbeck Foundation GeoGenetics Centre at the University of Copenhagen, Denmark partner to explore the relationship between the evolutionary history of select mental and neurological disorders and infectious pathogens. One of the first projects of its kind worldwide, the endeavor aims to acquire new knowledge in terms of the medical and biological understanding of special factors underlying the development of human neuropsychiatric diseases through the ages. Ultimately, the project may provide a new approach to the development of medicines and other therapeutic treatments for mental and neurological conditions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190325005867/en/ Where do brain disorders come from? In an effort to shed light on the role of microbes in the pathogenesis of neuropsychiatric illnesses, such as Alzheimer’s disease and schizophrenia, Professor Eske Willerslev and his team

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme