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- Research in haematological malignancies features VELCADE(R), siltuximab, ibrutinib and daratumumab - Note: This release corresponds to EHA abstracts S1345, P958, P957, P369, P353, P960, P1211, P1209, P461, P356, P350, P434, P109
Janssen Pharmaceutica NV announced data related to four compounds have been selected for presentation at the 19th European Hematology Association Congress (EHA) being held June 12-15, 2014 in Milan, Italy.
Data include VELCADE(R) (bortezomib), a first-in-class proteasome inhibitor to treat patients with multiple myeloma, which has also been investigated as a treatment for newly diagnosed patients with mantle cell lymphoma (MCL); siltuximab, an anti-interleukin-6 (IL-6) chimeric monoclonal antibody which recently received a positive CHMP opinion for the treatment of multicentric Castleman's disease (MCD). Data will also be presented for ibrutinib, an investigational compound which targets and blocks a specific protein (Bruton's tyrosine kinase) inhibiting cancer cell survival, in relapsed/refractory chronic lymphocytic leukaemia (CLL), MCL and other B-cell malignancies, and daratumumab, an investigational human CD38 monoclonal antibody being studied in multiple myeloma and other B-cell malignancies.
"Janssen has had a momentous year in haematology and has made significant progress across our portfolio since last year's EHA meeting. We are looking forward to presentations this year, which highlight important clinical data across our haematology compounds," said Jane Griffiths, Company Group Chairman of Janssen Europe, the Middle East and Africa (EMEA). "At Janssen, we are committed to pursuing compelling science, where the need, and opportunity for impact, are greatest for patients."
List of Company-Sponsored Research to Be Presented
The following VELCADE data have been accepted for presentation at EHA and were sponsored by Janssen or jointly sponsored by Janssen and its collaboration partner Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited:
- Phase 3 study of frontline rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in transplantation-unsuitable mantle cell lymphoma (MCL) patients (Abstract S1345) Oral abstract session: Aggressive Non-Hodgkin lymphoma - Clinical. Sunday 15 June 2014, 10:30-10:45 CEST in Auditorium (NW - Level 3) Lead Author: Tadeusz Robak, M.D., PhD, Department of Hematology, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland - Subcutaneous (SC) versus intravenous (IV) bortezomib in patients with relapsed multiple myeloma (MM): subanalysis of patients with renal impairment in the phase 3 MMY-3021 study. (Abstract P958) Poster presentation session: Myeloma and other monoclonal gammopathies - Clinical 3 (Poster). Saturday 14 June 2014, 17:45-19:00 CEST in e-Poster Area (NW - Level 0) Lead Author: Philippe Moreau, M.D., University Hospital, Nantes, France - First-line therapy for multiple myeloma (MM): results from the second interim analysis of the real-world, international, non-interventional EMMOS study. (Abstract P957) Poster presentation session: Myeloma and other monoclonal gammopathies - Clinical 3 (Poster). Saturday 14 June 2014, 17:45-19:00 CEST in e-Poster Area (NW - Level 0) Lead Author: Mohamad Mohty, M.D., PhD, Saint-Antoine Hospital, Pierre & Marie Curie University, Paris, France - Randomized phase 2 study of bortezomib, thalidomide, and dexamethasone with or without cyclophosphamide as induction therapy in previously untreated multiple myeloma (MM): Long-term follow-up results. (Abstract P369) Poster presentation session: Myeloma and other monoclonal gammopathies - Clinical 2 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Heinz Ludwig, M.D., Wilhelminen Cancer Research Institute, c/o First Department of Medicine, Center for Oncology, Haematology and Palliative Care, Wilhelminenspital, Vienna - Preliminary pre-randomization results from a phase 3 study of frontline subcutaneous (SC) bortezomib-based induction and consolidation in transplantation-eligible multiple myeloma (MM) patients (PTS). (Abstract P353) Poster presentation session: Myeloma and other monoclonal gammopathies - Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Noemi Horvath, M.D., Division of Haematology, SA Pathology/Royal Adelaide Hospital, Adelaide, SA - Effects of single-agent bortezomib (BTZ) as post-transplant consolidation on multiple myeloma (MM)-related bone disease: First results from a multicenter, randomized phase 2 study. (AbstractP960) Poster presentation session: Myeloma and other monoclonal gammopathies - Clinical 3 (Poster). Saturday 14 June 2014, 17:45-19:00 CEST in e-Poster Area (NW - Level 0) Lead Author: Orhan Sezer, M.D., PhD., Department of Hematology and Stem Cell Transplantation, Memorial Hospital, Istanbul
Two Janssen-sponsored abstracts for siltuximab have been accepted for presentation at EHA:
- Inflammatory and anemia-related markers in a phase 2, randomized, double-blind, placebo controlled study of siltuximab (ANTI-IL 6 monoclonal antibody) in multicentric Castleman's disease patients. (Abstract P1211) Poster presentation session: Non-malignant hematologic disorders (Poster). Saturday 14 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Corey Casper, M.D., MPH, Fred Hutchinson Cancer Research Center, Seattle, WA - Improvements in hemoglobin levels and fatigue in a randomized, double blinded, placebo controlled study (MCD3282001) of siltuximab in patients with multicentric Castleman's Disease (MCD). (Abstract P1209) Poster presentation session: Non-malignant hematologic disorders (Poster). Saturday 14 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Frits van Rhee, M.D., Ph.D., Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, United States
Ibrutinib data will be featured in more than two studies selected for presentation, and sponsored by either Janssen or its collaboration partner, Pharmacyclics, Inc.:
- Randomized comparison of ibrutinib versus ofatumumab in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma: results from the phase III RESONATE (TM) trial. Oral session: Presidential Symposium. Saturday 14 June 2014, 14:45-15:00 CEST in Room Gold (SW- Level 2) Lead Author: Peter Hillmen, MBChB, PhD, St. James University Hospital, Leeds, United Kingdom - Phase 2 study of ibrutinib in relapsed or refractory mantle cell lymphoma: Updated safety analysis on prevalence of infection, diarrhea, and bleeding over time. (Abstract P461) Poster presentation session: Aggressive Non-Hodgkin lymphoma - Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Simon Rule, M.D., Department of Haematology, Derriford Hospital, Plymouth, United Kingdom
Four daratumumab abstracts have been accepted for presentation and were jointly sponsored by Janssen and Genmab A/S. Janssen licensed daratumumab from Genmab A/S in 2012 and is working with the company to fully transition the development programme to Janssen. The selected daratumumab abstracts at EHA include:
- Dose-dependent efficacy of daratumumab (DARA) as monotherapy in patients with relapsed or refractory multiple myeloma (RR MM). (Abstract P356) Poster presentation session: Myeloma and other monoclonal gammopathies - Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Henk Lokhorst, M.D., Ph.D., UMC Utrecht, Utrecht, Netherlands, Utrecht, Netherlands - Safety and efficacy of daratumumab with lenalidomide and dexamethasone in relapsed or relapsed, refractory multiple myeloma. (Abstract P350) Poster presentation session: Myeloma and other monoclonal gammopathies - Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Torben Plesner, M.D., Vejle Hospital, Vejle, Denmark - Daratumumab treatment in combination with CHOP or R-CHOP results in the inhibition or regression of tumours in preclinical models of non-Hodgkins lymphoma. (Abstract P434) Poster presentation session: Non-Hodgkin & Hodgkin lymphoma - Biology 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Parul Doshi, M.D., Oncology Translational Medicine and Early Development. - Daratumumab treatment alone or in combination with vincristine results in the inhibition of tumor growth and long term survival in preclinical models of acute lymphocytic leukemia. (Abstract P109) Poster presentation session: Acute lymphoblastic leukemia - Biology 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in e-Poster Area (NW - Level 0) Lead Author: Parul Doshi, M.D., Oncology Translational Medicine and Early Development.
About VELCADE(R) (bortezomib) VELCADE (bortezomib) is a medicine used to treat the blood-based cancer known as multiple myeloma. It contains an active substance called bortezomib and is the first in a specific class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with the other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes causing myeloma cancer cells to stop growing and die.
VELCADE is the market leader in the treatment of frontline non-transplant eligible multiple myeloma. It is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies. Millennium is responsible for commercialisation of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialisation in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 550,000 patients worldwide.
About siltuximab Siltuximab is an anti-interleukin-6 (IL-6) chimeric monoclonal antibody that binds to human IL-6. IL-6 is a multifunctional cytokine produced by various cells such as T cells, B cells, monocytes, fibroblasts and endothelial cells. Dysregulated overproduction of IL-6 from activated B cells in affected lymph nodes has been implicated in the pathogenesis of, or mechanism causing, MCD. Information about ongoing studies with siltuximab can be found at http://www.clinicaltrials.gov.
On September 3, 2013 [http://www.investor.jnj.com/releasedetail.cfm?releaseid=788320], Janssen Research & Development, LLC announced simultaneous submissions of a Biologic License Application (BLA) to the U.S. FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treatment of patients with MCD who are HIV negative or HHV-8 negative. The EMA has granted Acceleration Assessment of the MAA. On March 20, 2014 [http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003708/WC500163475.pdf] , the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending the marketing authorization of siltuximab for the treatment of adult patients with MCD who are HIV negative or HHV-8 negative. The U.S. Food and Drug Administration's approval of SYLVANT(TM) was announced on April 23, 2014 [http://www.jnj.com/news/all/SYLVANT-siltuximab-Receives-FDA-Approval-to-Treat-Multicentric-Castlemans-Disease-MCD] . Siltuximab has been granted orphan drug status in MCD in the U.S. and European Union.
About Ibrutinib Ibrutinib is an investigational compound within a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. BTK is an important protein involved in mediating the cellular signalling pathways which control B cell maturation and survival. In malignant B cells, there is excessive signalling through the B cell receptor (BCR) and other signalling pathways, which includes BTK. The malignant cell ignores the natural signal to die and continues to develop and proliferate. Malignant cells migrate and adhere to protective environmental areas such as the lymph nodes where they proliferate and survive. Ibrutinib is specifically designed to target and inhibit BTK. Ibrutinib forms a strong covalent bond with BTK, which inhibits the excessive transmission of cell survival signals within the malignant B cells and stops their excessive build up in these protected environmental areas. The efficacy and safety of ibrutinib alone and in combination with other treatments is being studied in several blood cancers including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and multiple myeloma (MM).[3-7]
On October 30, 2013 [http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=801510], Janssen-Cilag International NV submitted a New Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory CLL/small lymphocytic lymphoma (SLL) or relapsed or refractory MCL.
Ibrutinib is marketed as IMBRUVICA(R) in the U.S., where it received approval on November 13, 2013 [http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm374857.htm] from the U.S. Food and Drug Administration (FDA) for the treatment of patients with MCL who have received at least one prior therapy, followed by further indication approval on February 12, 2014 [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm385764.htm] for the treatment of patients with CLL who have received at least one prior therapy.
On August 30, 2012 [http://www.jnj.com/connect/news/all/janssen-biotech-announces-global-license-and-development-agreement-for-investigational-anti-cancer-agent-daratumumab] , Genmab A/S granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab. Daratumumab is an investigational human IgG1 monoclonal antibody (mAb) that binds with high affinity to CD38 on surface of multiple myeloma cells and induces rapid tumor cell death through diverse mechanisms of action. Daratumumab is in Phase 3 clinical development for multiple myeloma, and may also have potential in other malignant and pre-malignant diseases on which CD38 is expressed. On May 1, 2013 [http://files.shareholder.com/downloads/JNJ/2326545610x0x659177/a8f5219f-2dae-4252-b578-e5baad03ff72/JNJ_News_2013_5_1_Financial_Releases.pdf] , daratumumab was granted Breakthrough Therapy Designation by the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found on http://www.janssen-emea.com. Follow us on http://www.twitter.com/janssenEMEA for our latest news.
Janssen Pharmaceutica NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumour microenvironment.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of any of the Janssen Pharmaceutical Companies or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description 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 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)
1) VELCADE EPAR Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000539/human_med_001130.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 . Accessed April 2014. 2) El-Osta HE, Kurzrock R. Castleman's disease: from basic mechanisms to molecular therapeutics. Oncologist. 2011;16:497-511. 3) Qiu Y, Kung HJ. Signaling network of the Btk family kinases. Oncogene. 2000;19:5651-61. 4) Shaffer AL, Rosenwald A, Staudt LM. Lymphoid malignancies: the dark side of B-cell differentiation. Nat Rev Immunol. 2002;2:920-32. 5) Puri KD, di Paolo JA, Gold MR. B-cell receptor signaling inhibitors for treatment of autoimmune inflammatory diseases and B-cell malignancies. Int Rev Immunol. 2013;32:397-427. 6) Woyach JA, Johnson AJ, Byrd JC. The B-cell receptor signaling pathway as a therapeutic target in CLL. Blood. 2012;120:1175-84. 7) Akinleye A, Chen Y, Mukhi N, Song Y, Liu D. Ibrutinib and novel BTK inhibitors in clinical development. J Hematol Oncol. 2013;6:59.
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