ZYTIGA (abiraterone acetate) Data to be Presented at 2012 American Society of Clinical Oncology (ASCO) Annual Meeting
Note: This release corresponds to ASCO abstracts LBA 4518, 4521, 4556 and 4558
RARITAN, N.J., May 18, 2012 /PRNewswire/ -- 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, LLC.
"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-naive 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
About ZYTIGA
"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.
Indication
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 less than 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-infinity (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 (greater than
or equal to 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.
SOURCE Janssen Research & Development, LLC
CONTACT: Kellie McLaughlin, +1-908-927-7477 office, or
+1-609-468-8356 cell, or Investor Relations, Stan Panasewicz,
+1-732-524-2524 office, or Louise Mehrotra, +1-732-524-6491 office,
or U.S. Medical Inquiries, +1-800-JANSSEN (800-526-7736)
Web Site: http://www.janssenrnd.com
Posted: May 2012
