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Phase III Study Shows No Survival Benefit With Afinitor (Everolimus) in Advanced Liver Cancer

Drug is approved for breast cancer treatment in U.S. (August 7)

Results of a global phase III study showed that Affinitor (everolimus) did not extend overall survival compared with placebo in patients with locally advanced or metastatic hepatocellular carcinoma (HCC) after progression on or intolerance to sorafenib. Hepatocellular carcinoma, an aggressive and debilitating cancer, is the most common type of liver cancer. The drug’s manufacturer (Novartis) will not proceed with regulatory filings of Afinitor in this indication.

The results of the HCC trial do not affect the worldwide approvals of Afinitor for other indications. Everolimus is also in phase III development in other diseases, including gastrointestinal and lung neuroendocrine tumors (NET), HER2-positive breast cancer, lymphoma, and tuberous sclerosis complex (TSC). The results of these trials are expected during 2014 and 2015.

The phase III EVOLVE-1 (EVerOlimus for LiVer Cancer Evaluation-1) trial evaluated the efficacy and safety of everolimus versus placebo, plus best supportive care (BSC), in 546 adult patients with advanced HCC whose disease progressed after treatment with or who were intolerant to sorafenib, a targeted therapy. The patients were randomly assigned to receive therapy with everolimus 7.5 mg/day orally plus BSC or placebo plus BSC. The primary endpoint was overall survival.

In the U.S., Afinitor (everolimus) is approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after the failure of treatment with letrozole or anastrozole.

Source: Novartis; August 7, 2013.

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