New Trial for Liver Cancer Treatment

Patients are currently being enrolled in a trial involving liver cancer patients, for Onyx and Bayer Healthcare Pharmaceuticals drug, Nexavar. The trial is an effort to show the positive effects of the drug as an adjuvant treatment, or additional therapy administered after initial tumor treatment, to hopefully fight cancer cells that may have spread to other areas of the body. Nexavar is currently used to treat patients with unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer, and those with the most common type of kidney cancer, advanced renal cell carcinoma (RCC).

Liver cancer treatments have had very limited success in the past. Surgical removal of liver tumors is the best option currently. However, very often liver tumors are inoperable, because they are too large or have grown into major blood vessels or other vital areas. Liver cancer ranks third in the world for cancer deaths and about 18,500 cases of primary liver cancer is diagnosed each year. Primary liver cancer is twice as common in men, than it is in women. An estimated 70 percent of all people with uncontrolled cancer will develop secondary liver tumors at some point.

The trial, known as STORM, will need 1,100 patients to test Nexavar's effects on previously treated liver cancer, in hopes of warding off its return. The tests will last around four years. During the trial, volunteer post-liver cancer patients will be given Nexavar or a Placebo tablet twice daily.

STORM will hopefully add additional data to the company's previous phase III trial involving Nexavar that demonstrated higher survival rates overall in patients with unresectable liver cancer. The phase III trial, lead to Nexavar being approved in the U.S. and Europe to treat primary liver cancer. Around 200 sites around the world will be used for the STORM study. The FDA has already collected their SPA, Special Protocol Assessment, for the trial study, which indicates the clinical trial is the correct size and format to support a new drug application to be marketed in the U.S.

Currently there are no other adjuvant treatments available to treat primary liver cancer. If Nexavar is approved to be used as an adjuvant treatment, it will be the first. All strides made to help prevent cancer or recurrences are wonderful. Those who volunteer to participate in the trial may help lead to a cure or prevention for liver cancer, and possibly even other forms of cancer.