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August 7, 2013

Novartis’ Afinitor Phase III trial fails to meet primary end-point

Switzerland-based Novartis’ Phase III trial of advanced liver cancer drug, Afinitor (everolimus), did not meet the primary end-point of overall survival benefit in patients with advanced hepatocellular carcinoma (HCC) after progression on or intolerance to sorafinib.

Switzerland-based Novartis’ Phase III trial of advanced liver cancer drug, Afinitor (everolimus), did not meet the primary end-point of overall survival benefit in patients with advanced hepatocellular carcinoma (HCC) after progression on or intolerance to sorafinib.

Designed to examine the efficacy and safety of Afinitor versus placebo, the double-blind, placebo-controlled Phase III study, everolimus for liver cancer evaluation-1 (EVOLVE-1), trial involved 546 patients at 156 sites globally.

Novartis Oncology medical affairs and oncology development global head Alessandro Riva said that the company is committed to studying everolimus through a robust research and development program to address unmet needs in different types of cancer.

"Results of the HCC trial will not impact the worldwide approvals of Afinitor for other indications."

"To date, Afinitor has proven efficacy in a number of tumor types, including hormone receptor positive advanced breast cancer, advanced pancreatic neuroendocrine tumours and advanced renal cell carcinoma," Riva said.

In the EVOLVE-1 trial, patients were randomised in the ratio 2:1 with everolimus 7.5mg/day orally plus best supportive care (BSC) or placebo plus BSC.

Secondary end-points of the trial included time to tumour progression, disease control rate, time to deterioration of performance status, safety and quality of life.

Results of the HCC trial will not impact the worldwide approvals of Afinitor for other indications.

Afinitor is currently in Phase III trial to examine its efficacy in gastrointestinal and lung neuroendocrine tumours, HER2 positive breast cancer, lymphoma and tuberous sclerosis complex diseases, with results expected in 2014 and 2015.

The drug is approved for the treatment of advanced breast cancer in the US and the EU.

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