Important ZYTIGA® Prostate Cancer Data Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting

Phase 3 Results Show Significant Improvement in Radiographic Progression-Free Survival and a Trend for Increased Overall Survival in Patients Receiving ZYTIGA® Plus Prednisone

TORONTO, June 2, 2012 /CNW/ - New data presented this weekend at the 48^th annual meeting of the American Society of Clinical Oncology (ASCO) showed ZYTIGA® (abiraterone acetate) may prove to be an important new treatment option for metastatic prostate cancer patients prior to receiving chemotherapy. This is the first randomized study to demonstrate a radiographic progression-free survival benefit and an overall survival trend in this patient population.

The COU-AA-302 Phase 3 study investigated the use of ZYTIGA® plus prednisone compared to placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.  The data demonstrated a statistically significant improvement in radiographic progression-free survival (rPFS) in the ZYTIGA® plus prednisone arm of the study compared to the placebo plus prednisone (control) arm (HR=0.43; 95 per cent CI: [0.35, 0.52], p<0.0001). Additionally, treatment with ZYTIGA® plus prednisone reduced the risk of death from disease progression by 25 per cent (median overall survival (OS) in the ZYTIGA® arm was not reached and was 27.2 months in the control arm; HR=0.75; 95 per cent CI: [0.61, 0.93], p=0.0097).  At the time of these interim analyses, the pre-specified p-value of 0.0008 to achieve statistical significance was not reached.

"Great treatment advancements have been made in metastatic prostate cancer, which is exciting news for a patient population that until recently didn't have many treatment options," said Dr. Martin Gleave, British Columbia Leadership Chair, Professor and Distinguished University Scholar, Department of Urological Sciences, University of British Columbia, Director, The Vancouver Prostate Centre, University of British Columbia and one of the study's Canadian investigators. "The data announced at ASCO is important as it adds to the growing body of evidence supporting ZYTIGA®'s role for metastatic prostate cancer patients."

ZYTIGA® is an oral medication for prostate cancer.  In July 2011, ZYTIGA® was approved by Health Canada with prednisone for the treatment of men with metastatic prostate cancer (castration-resistant prostate cancer) who have received prior chemotherapy containing docetaxel. It is the first oral treatment that inhibits androgen production at all three sources - the testes, adrenal glands and in the tumour itself.

About the COU-AA-302 Study
COU-AA-302 is an international, randomized, double-blind, placebo controlled Phase 3 study that included 1,088 men, including 100 Canadians, with mCRPC who had not received prior chemotherapy, who were randomized to receive ZYTIGA® 1,000 milligrams (mg) administered orally once daily plus prednisone five mg administered twice daily or placebo plus prednisone five mg administered twice daily.  The co-primary endpoints of the study are rPFS and OS.

Patients in the ZYTIGA® arm of the study experienced more grade 3 and grade 4 adverse events than those in the control arm, including cardiac disorders (6 per cent vs. 3 per cent) and hypertension (4 per cent vs. 3 per cent), as well as increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (5.4 per cent vs. 0.8 per cent and 3.0 per cent vs. 0.9 per cent, respectively).  Fatigue was the most common adverse event observed in the study.

About Prostate Cancer in Canada
Prostate cancer is the most common cancer to afflict men in Canada and approximately 26,500 men are diagnosed with prostate cancer annually. According to Prostate Cancer Canada, prostate cancer is turning up in men in their 40s and on average, 73 Canadian men are diagnosed with prostate cancer every day.  If prostate cancer is detected and treated early, it can be cured. Fortunately, death rates have been declining since the mid-1990s, likely due to early detection, better treatment or both.¹

About Janssen Inc.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women's health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.

References
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¹ Prostate Cancer Facts.  Prostate Cancer Canada.  Available at: http://www.prostatecancer.ca/Prostate-Cancer/Prostate-Cancer/Prostate-Cancer-Facts.   Accessed May 15, 2012.

SOURCE Janssen Inc.