RARITAN, NJ, May 18, 2012 – Data related to ZYTIGA® (abiraterone acetate) clinical studies have been selected for presentation at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO). Additionally, data regarding the investigational compounds ibrutinib and siltuximab also have been accepted for presentation. Additional abstracts were also accepted as publication-only or in the trial in progress category. These studies were sponsored by Janssen Research & Development, L.L.C.
“The depth and breadth of data sponsored by Janssen Research & Development that will be presented at this year’s ASCO Annual Meeting will add important scientific insight in a number of key oncology disease states,” said William N. Hait, M.D., Ph.D., Global Head, Janssen R&D and Head, Oncology Therapeutic Area. “These data presentations demonstrate our ongoing commitment to furthering the understanding of our compounds in a number of hematology and oncology settings.”
The following ZYTIGA clinical study abstracts have been selected for presentation:
Interim analysis (IA) results of COU-AA-302, a randomized, phase 3 study of abiraterone acetate (AA) in chemotherapy-naïve patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (Abstract LBA 4518)
Clinical Science Symposium: New Paradigms for Hormone Therapy in Prostate Cancer, Saturday, June 2, 8:00 – 8:15 a.m., E. Arie Crown Theater
Lead Author: C.J. Ryan, M.D., Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA
Effect of neoadjuvant abiraterone acetate (AA) plus leuprolide acetate (LHRHa) on PSA, pathological complete response (pCR) and near pCR in localized high-risk prostate cancer (LHRPC): Results of a randomized phase 2 study (Abstract 4521)
Clinical Science Symposium: New Paradigms for Hormone Therapy in Prostate Cancer, Saturday, June 2, 9:10 – 9:20 a.m., E. Arie Crown Theater
Lead Author: M.-E. Taplin, M.D., Dana-Farber Cancer Institute, Boston, MA; Harvard Medical School, Boston, MA
Exploratory analysis of survival benefit and prior docetaxel (D) treatment in COU-AA-301, a phase 3 study of abiraterone acetate (AA) plus prednisone (P) in metastatic castration-resistant prostate cancer (mCRPC) (Abstract 4558)
Poster Discussion Session: Genitourinary (Prostate) Cancer, Monday, June 4, 8:00 a.m. – 12:00 p.m., E450a, Poster Board #12
Lead Author: O.B. Goodman, Jr, M.D., Ph.D., Nevada Cancer Institute, Las Vegas, NV
Cytoreduction and androgen signaling modulation by abiraterone acetate (AA) plus leuprolide acetate (LHRHa) vs LHRHa in localized high-risk prostate cancer (PCa): Preliminary results of a randomized preoperative study (Abstract 4556)
Poster Discussion Session: Genitourinary (Prostate) Cancer, Monday, June 4, 8:00 a.m. – 12:00 p.m., E450a, Poster Board #10
Lead Author: E. Efstathiou, M.D., Ph.D., David H Koch Center for Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX; University of Athens, Athens, Greece
“Since its first approval in the U.S. in 2011, ZYTIGA has been approved in more than 40 additional countries, many thousands of men have received treatment with it, and it is quickly becoming one of the cornerstones of our oncology offerings,” said Hait.
ZYTIGA in combination with prednisone was approved by the U.S. Food and Drug Administration (FDA) in April 2011 for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. The Phase 3 study for this initial ZYTIGA indication was unblinded in August 2010, based on results from a planned interim analysis showing a statistically significant improvement in overall survival and an acceptable safety profile. A subsequent analysis with more mature data confirmed the survival benefit and safety profile.
For more information about ZYTIGA, visit www.ZYTIGA.com.
ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.
Important Safety Information
Contraindications - ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.
Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess - Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in hypertension, hypokalemia, and fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure because these patients were excluded from the randomized clinical trial. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.
Adrenocortical Insufficiency (AI) - AI has been reported in clinical trials in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.
Hepatotoxicity - Increases in liver enzymes have led to drug interruption, dose modification, and/or discontinuation. Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.
Food Effect - ZYTIGA® must be taken on an empty stomach. Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞(exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.
Adverse Reactions - The most common adverse reactions (=5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.
Drug Interactions - ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid coadministration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.
Use in Specific Populations - The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.
About Ibrutinib (formerly PCI-32765)
Ibrutinib is a first-in-class oral, selective Bruton's tyrosine kinase (Btk) inhibitor being investigated for its potential in treating patients with chronic lymphocytic leukemia, Mantle Cell lymphoma, diffuse large B cell lymphoma, follicular lymphoma and multiple myeloma, all of which are considered B-cell malignancies. Ibrutinib is being jointly developed by Janssen and Pharmacyclics, Inc.
About Siltuximab (formerly CNTO 328)
Siltuximab is a novel anti-interleukin-6 monoclonal antibody that is being investigated for its potential to treat patients with multi-centric Castleman's disease, multiple myeloma, smoldering myeloma and myelodysplastic syndromes.
About Janssen Research & Development, LLC
Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com.
Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world.
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