A cutting-edge pill developed by an Emeryville biotechnology company extended the survival times of people with advanced liver cancer by nearly three months compared with a placebo, according to a study released Monday, a result hailed as a significant improvement in a disease with few good treatment options.
Scientists who conducted the trial of Onyx Pharmaceuticals' drug Nexavar unveiled th More..e results at the annual meeting of the American Society of Clinical Oncology. Onyx's shares gained $2.64 to close at $33.52 Monday.
Onyx and its co-development partner, Bayer Pharmaceuticals Corp., plan to ask the Food and Drug Administration to approve Nexavar as a liver cancer treatment based on the data just made public. The decision could come by early 2008, Onyx chief executive Hollings Renton said.
Nexavar is already approved to treat kidney cancer and is being studied in a range of other cancer types, including melanoma, lung cancer and breast cancer.
The drug is designed to block the formation of blood vessels that feed tumors and also interferes with cellular processes that foster rapid growth. It's an example of the burgeoning class of drugs that home in on the specific molecular mechanisms behind cancer -- one of the hottest areas in drug development.
Progress with drugs such as Nexavar and Genentech's Avastin has opened new commercial possibilities for the biotechnology and pharmaceutical industries, and attracted intense interest from investors.
Although Nexavar is not a cure, its ability to lengthen survival could make it the standard of care for all liver cancer patients who are not eligible for surgery, Cowen & Co. analysts predicted.
Most liver cancers are diagnosed at a late stage and most patients die within a year, according to the American Society of Clinical Oncology, which featured the Nexavar study as one of the most noteworthy trials to be reported at its meeting in Chicago.
Current treatment options for advanced liver cancer include surgery, radiation and chemotherapy delivered into the liver. Nexavar is the first systemic drug -- that is, a drug reaching the bloodstream by injection or oral medicine -- that has ever proven effective in treating liver malignancies, the cancer research organization said.
In a study of 602 people, those on Nexavar had a median survival time of 10.7 months, compared with 7.9 months for those given a placebo. By a separate statistical measurement that evaluates the reduced risk of death, the survival improvement was 44 percent.
The study was stopped early after an interim analysis of the data indicated a clear survival benefit, Onyx and Bayer announced in February without disclosing the data.
About 19,000 people are diagnosed with liver cancer in the United States every year, and about 17,000 people die of the disease, the cancer research organization said. The disease is linked to infections with hepatitis B and hepatitis C. Alcoholism and food contamination are also contributing factors.
Nexavar costs $4,500 a month, and liver cancer patients would take it until tumors resume growing or perhaps longer, Renton said. In the study subjects on Nexavar, the median time before the disease worsened was 5 1/2 months, compared with 2.8 months for those on a placebo.
Renton said Onyx participates in patient-assistance programs for the uninsured and those who can't make insurance co-payments, and will evaluate the need for expanded efforts.
Cowen analysts estimate that Nexavar could reach sales over $1 billion by 2011, with $745 million in treatments for liver cancer.
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