Novartis’ hopes to expand the use of cancer drug Afinitor took a blow as the drug failed to reach its primary endpoint in a late-stage trial investigating its use in advanced liver cancer.
The drug did not extend overall survival compared to placebo in patients with locally advanced or metastatic hepatocellular carcinoma as a second-line therapy to Bayer’s Nexavar (sorafenib), said Novartis.
As a result, the company said it will not proceed with regulatory filings for Afinitor (everolimus) in this indication, halting a series of cancer approvals for the drug, which is available for the treatment of breast cancer, pancreatic cancer and kidney cancer.
Through its approval in these areas, Afinitor has become one of Novartis’ most important new drugs, making $797m during 2012, and it seems to be on its way to blockbuster status, achieving revenues of $611m in the first half of 2013.
The company even said that Afintor, along with other new treatments Lencutis, Gilenya and Tasigna, will put the company back onto sales growth from 2014 after a couple of flat years due to patent losses.
The latest trial disappointment puts a minor dent in those ambitions, however, considering hepatocellular carcinoma is the most common type of liver cancer, leading to between 250,000 and one million deaths worldwide each year.
Aside from Nexavar, there are few treatment options, and just last year, Bristol-Myers Squibb said its investigational cancer drug brivanib failed in a phase III trial in the condition.
Novartis has hopes for Afinitor in other cancers, however, with the drug in phase III development in gastrointestinal and lung neuroendocrine tumors, HER2 positive breast cancer, lymphoma and tuberous sclerosis complex.
Results of these trials are expected in 2014 and 2015.