(Reuters) - Exelixis Inc’s drug to treat a type of liver cancer improved overall survival in patients in a late-stage study that prompted an independent expert group to recommend no further trial, sending the company’s shares soaring 31 percent.
The recommendation by the external data monitoring committee for terminating a trial typically paves the way for companies to get early regulatory approvals for their treatments in the United States.
In the latest trial, the drug, cabozantinib, showed statistically significant improvement in overall survival in advanced hepatocellular carcinoma (HCC) patients who had been previously treated with Bayer and Amgen’s sorafenib, as compared with a placebo, the company said.
“With this clinical hurdle removed, we view the company as one of the prime takeout targets,” William Blair analyst Andy Hsieh wrote in a client note.
Exelixis, which has a market value of about $7.30 billion, plans to file for an expanded label with the U.S. Food and Drug Administration in the first quarter of 2018.
Hsieh said the drug’s success in the late-stage trial should help the company penetrate the $1.1 billion global market for HCC.
The drug was approved for treating kidney cancer in 2016 and is sold under the brand name Cabometyx.
The market for HCC drugs is heating up following recent approvals of Bristol-Myers Squibb’s blockbuster immunotherapy, Opdivo, and Bayer AG’s Stivarga.
Sorafenib, sold under the brand name Nexavar, was approved to treat liver cancer in 2007.
“As is typical protocol, we will speak with FDA about stopping the trial, so that patients can cross over,” Exelixis spokeswoman Susan Hubbard told Reuters.
About 40,710 people will be diagnosed with liver cancers in 2017 and about 28,920 will die of the diseases, according to the National Cancer Institute.
Exelixis’ shares were trading at $32.50 in morning trading on Monday. They have risen 86.2 percent since the beginning of the year.
Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Anil D’Silva
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