Swiss drugmaker Roche Holding AG (RHHBY.PK) said Friday that its cancer drug Avastin failed to meet its primary goal of extending overall survival in a phase III prostate cancer trial.
The late-stage trial led by the U.S. Cancer and Leukemia Group B and sponsored by the National Cancer Institute investigated the use of Avastin in combination with docetaxel chemotherapy and steroid prednisone in men with advanced prostate cancer.
The study, known as CALGB 90401, did not meet its primary objective of extending overall survival compared to chemotherapy and prednisone alone, according to Roche's unit Genentech. Avastin came into Roche's fold, following the acquisition of Genentech last year.
Roche noted that a preliminary assessment of safety performed by CALGB has shown adverse events that have been previously observed in pivotal trials with Avastin. However, the findings do not impact Avastin's approved uses or its broad development program in other tumor types, the company said.
Prostate cancer is the second leading cause of cancer death in American men, next to lung cancer. According to the American Cancer Society, in 2009 an estimated 192,000 men were diagnosed with prostate cancer and approximately 27,000 died from the disease in the United States.
Avastin, which was first approved in 2004 as a treatment for colorectal cancer, is also approved for the expanded indications of breast, lung and kidney cancers. In 2009, the drug generated global sales of 6.2 billion Swiss francs ($5.7 billion).
According to Roche, approval of Avastin in the prostate cancer setting had the potential to add 500 million to 1 billion Swiss francs per year.
On February 22, Roche announced that Avastin failed in a late-stage trial of stomach cancer. The company had predicted Avastin sales for stomach cancer indication to range between 500 million and 1 billion Swiss francs, according to Deutsche Bank analysts.
On February 25, Roche announced promising results from a phase III study of Avastin in women with advanced ovarian cancer. If approved for the indication of ovarian cancer, Avastin could rake in an additional 1 billion Swiss francs in sales, according to analysts.
Data from the Avastin studies will be submitted for presentation at the American Society of Clinical Oncology annual meeting, June 4 to 8, 2010.
RHHBY.PK is currently down 1.775 trading at $40.98 on a volume of 115,685 shares.
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