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Janssen’s Zytiga boosts survival in early-stage prostate cancer

Published on 14/03/16 at 10:21am

Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall survival (OS) by 11.8 months compared with placebo plus prednisone, in men with early and less aggressive metastatic castration-resistant prostate cancer (mCRPC) who had not received chemotherapy.

Data presented today at the European Association of Urology (EAU) 2016 Congress in Munich, Germany, demonstrated that in the COU-AA-302 trial, Zytiga (abiraterone acetate) increased OS to 53.6 months versus the 41.8 months achieved by patients treated with prednisone alone. This benefit was shown to be 4.4 greater than that previously reported for the combo in the final analysis of the COU-AA-302 trial in 2014.

The post-hoc analysis divided patients into two groups to identify which group experienced a greater treatment benefit. The patients in group 1 were in an earlier, less advanced and less symptomatic stage of the disease, while those in group 2 were in a later, more advanced and more symptomatic stage of the disease.

While both groups experienced an OS benefit when treated with the Zytiga/prednisone combo, the benefit was greater in the men with early-stage disease. The latter stage group’s overall survival was 2.8 months greater than that of patients treated with prednisone only.

In addition to OS benefit, the post-hoc analysis data also revealed that both groups showed improvement in disease progression, cancer-related pain and treatment duration when treated with the combination. Time to chemotherapy use was increased by 12.7 months in group 1 and 8.8 months in group 2.

“Post-hoc analyses such as this are very important in helping us to identify the patients who could benefit most from therapies such as novel hormone agents, and at what stage of a patient’s disease they could be most effective.” says Professor Kurt Miller, Department of Urology, Charité Berlin, Berlin, Germany. “As men with prostate cancer are living longer, quality of life is an increasingly important factor for them and their families. It is therefore encouraging to see that when used earlier, patients can stay on abiraterone acetate for longer and delay the need for additional, more invasive treatments,” he continued.

Jane Griffiths, company group chairman, Janssen Europe, the Middle East and Africa (EMEA) comments: “Janssen is proud that this study continues to deliver valuable insights as to how best to treat different stages of advanced prostate cancer. We hope that this additional analysis will help healthcare professionals to define the most effective treatment pathway for individual patients. We remain committed to continuing our research in this area with the aim of helping to improve outcomes for men affected by this disease now and in the future.”

Joel Levy

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