CHICAGO A drug delivery system developed by Delcath Systems Inc helped melanoma patients whose cancer had spread to their liver live more than three times as long as patients treated with best available care.
The company, which announced in April that the 93-patient trial was successful, said patients treated with its "Percutaneous Hepatic Perfusion" system lived for an average of 398 days before dying or having their cancer get worse. Patients treated with standard drugs survived for an average of 124 days before they died or their tumor growth restarted.
"This is the overall survival show-stopper," said Delcath Chief Executive Officer Eamonn Hobbs.
Delcath's system is designed to deliver high doses of the chemotherapy drug melphalan directly to the liver, through the hepatic artery. The drug is very toxic, but not for normal cells in the liver.
"This clearly shows that you can deliver a much higher dose of chemotherapy and get a tumor response," said Dr. Lynn Schuchter, professor of medicine at the University of Pennsylvania's Abramson Cancer Center.
The system aims to minimize side effects by filtering the drug out of the blood stream as it leaves the liver, but some of the drug leaks out. The major side effect seen in the trial was bone marrow suppression.
"We would like to minimize that going forward," Hobbs said.
The system causes "a fair amount of toxicity" and would need to be used only at centers with expertise in monitoring patients, Schuchter said.
She said two patients, or 2.5 percent, died as a result of the treatment.
Delcath has begun a rolling application for its PHP system at the U.S. Food and Drug Administration and expects to complete the package later this year.
The company has estimated peak annual U.S. sales of $745 million if the system is approved for use in melanoma patients whose cancer has spread to the liver. Use in primary liver cancer as well as metastases from other types of cancer could put the sales potential at $5.6 billion.
Hobbs said Delcath is also exploring ways to use its system in patients with other types of solid tumors in combination with other kinds of chemotherapy drugs.
(Reporting by Deena Beasley; Editing by Peter Cooney)