ZYTIGA Plus Prednisone Demonstrates Statistically Significant Overall Survival After 49-Month Follow-Up Analysis in Chemotherapy-Naïve Men with Metastatic Castration-Resistant Prostate Cancer

Final analysis of Phase 3 study COU-AA-302 presented at the

2014 European Society for Medical Oncology (ESMO) Conference

NOTE: this press release relates to ESMO abstract #5936 and C Ryan Oral Presentation 753O, 28th September 11:00 hours CET

High Wycombe, 28 September 2014: Data from the final analysis of the Phase 3 study COU-AA-302 have shown that Zytiga® (abiraterone acetate) plus low dose prednisolone significantly prolongs overall survival (OS) with a median life extension of 4.4 months among men with metastatic castration resistant prostate cancer (mCRPC) who have not previously been treated with chemotherapy (median OS, 34.7 vs 30.3 mos with placebo plus prednisolone; HR=0.81 [95% CI, 0.70-0.93]; p=0.0033), after a median follow-up of more than four years (49.2 months).1

The final analysis, presented today at the European Society for Medical Oncology (ESMO) conference in Madrid, is the first to demonstrate a statistically significant improvement in OS in this study. This is particularly noteworthy as men in both treatment arms received other subsequent therapy, including the 44 percent of men in the placebo plus prednisolone arm who subsequently received abiraterone plus prednisolone. The treatment effect with abiraterone was more pronounced when adjusting for 44 percent of prednisolone patients who crossed over to abiraterone (HR = 0.74).1

Commenting on the study results, Dr Alison Birtle, Consultant Clinical Oncologist at the Rosemere Cancer Centre, Royal Preston Hospital, said: “This study has previously shown that abiraterone provides an effective treatment option for patients with metastatic, hormone-resistant, disease who wish to delay or avoid chemotherapy. It has now shown that treatment with abiraterone can also add more than four months additional survival in these patients. The availability of a treatment option that can both maintain quality of life and also increase survival is a very welcome development.”

The final analysis also showed a significant improvement in time to opiate use among those in the abiraterone arm versus placebo (33.4 vs 23.4 mos; HR=0.72 [95% CI, 0.61-0.85]; p=0.0001). With two additional years of follow-up since the last clinical cut-off (median 49.2 months), the safety profile of abiraterone remained unchanged, with no observed change in low dose prednisolone-related toxicity. Side effects were more common in the abiraterone arm versus placebo, with the most commonly reported grade 3/4 adverse events being: hypertension (4.6% vs 3.1%), hypokalemia (2.6% vs 1.9%), liver toxicities (increased alanine aminotransferase (ALT), 5.9% vs 0.7%) and increased aspartate aminotransferase (AST) (3.3% vs 0.9%), and fluid retention/oedema (1.1% vs 1.7%).1 2

Dr Peter Barnes, Medical Director at Janssen, commented: “These data demonstrate clearly the clinical value of abiraterone to this group of patients. We continue to work closely with NICE and the Department of Health with the aim to have this medicine routinely available on the NHS."

In August the NICE Final Appraisal Determination (FAD) on the use of abiraterone before chemotherapy did not recommend the medicine at this stage of the disease. In September NICE suspended the appraisal to allow Janssen to submit an amended patient access scheme to the Department of Health. This proposal is currently before the Department of Health for consideration.

Regulatory authorities in both Europe and the United States approved abiraterone acetate for use before chemotherapy in December 2012.2 Since then it has been prescribed to slow the progression of the disease and delay the need for chemotherapy in many thousands of patients across Europe and the United States, and has become the second most requested treatment on the NHS Cancer Drugs Fund (CDF).3

Abiraterone was discovered in the UK, and its use around the world as a mainstream treatment represents a major success story for the UK life sciences industry.

For further information please contact:

Janssen
Miriam Cox: 07788 338 127

Munro & Forster
Stephanie Snow: 07747 636 838

NOTES TO EDITORS:

About study COU-AA-302

COU-AA-302 is an international, randomised, double-blind, placebo controlled Phase 3 study that included 1,088 men with mCRPC who had not received prior chemotherapy and were randomised to receive 1,000 mg of abiraterone, administered orally once-daily plus prednisolone 5 mg administered twice daily or placebo plus prednisolone 5 mg administered twice daily. The co-primary endpoints of the study were radiographic progression-free survival (rPFS) and overall survival (OS). Key secondary endpoints included time to opiate use, time to initiation of chemotherapy, time to Eastern Cooperative Oncology Group (ECOG) performance status deterioration and time to prostate-specific antigen (PSA) progression. 1

About the use of abiraterone before chemotherapy

In December 2012 abiraterone received a licence from the European Medicines Agency (EMA) for use in conjunction with prednisolone, in patients with metastatic castration resistant prostate cancer who have limited or no symptoms, whose disease is progressing despite hormone therapy, but which is not so advanced that chemotherapy is necessary.2

Abiraterone is now routinely available to patients in 76 countries across the world for this patient group who are not yet eligible for chemotherapy.

Between April 2013 and March 2014 3,023 patients have been able to access abiraterone prior to chemotherapy via the Cancer Drugs Fund (CDF). 3 However, this scheme covers England only, and will only provide a safety net for English patients until 2016.

To access the full Summary of Product Characteristics (SmPC), please visit the electronic Medicines Compendium (eMC) at http://www.medicines.org.uk/EMC/medicine/24976/SPC/Zytiga+250+mg+tablets...

Prostate Cancer information

More information about prostate cancer can be found on the sites listed below:

Cancer Research UK: www.cancerresearchuk.org

The Prostate Cancer Support Organisation: www.pcaso.org/

Tackle Prostate Cancer (formerly The Prostate Cancer Support Federation): http://www.tackleprostate.org/

Prostate Cancer UK: http://prostatecanceruk.org/

Macmillan Cancer Support: http://www.macmillan.org.uk/

Orchid: http://www.orchid-cancer.org.uk/

* Please note that Janssen is not responsible for the content of independent websites.

About Janssen

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, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. The legal entity for Janssen in the UK and Ireland is Janssen-Cilag Ltd. Please visit www.janssen.co.uk for more information.

References:

1. Ryan, CJ, et al. Abstract 5936 presented at ESMO 2014, Madrid, Spain.

2. Zytiga SPC. Available at: https://www.medicines.org.uk/emc/medicine/24976/SPC/Zytiga+250+mg+tablet... (accessed 23 September 2014)

3. NHS England, The Cancer Drugs Fund http://www.england.nhs.uk/ourwork/pe/cdf/ (accessed 23 September 2014)

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