Delcath Systems produced striking data at ASCO demonstrating that its new delivery system to spur chemotherapy saturation in key targets significantly outperformed standard therapy for liver cancer. A reviewer, though, criticized some aspects of the Phase III trial, and Delcath's shares--a star performer overall this year--plunged more than 20 percent.
Patients treated with Delcath's "percutaneous hepatic perfusion" system lived or survived without disease progression for an average of 398 days compared to an average of only 124 days for the standard drug group. And Delcath CEO Eamonn Hobbs described the data as a "survival show-stopper."
The system is designed to deliver a high dose of chemotherapy directly to the liver and then filter most of it out before it returns to the bloodstream. Bone marrow suppression was the most serious adverse event reported, which the company plans to minimize as much as possible.
From here Delcath plans to push ahead with its rolling submission to the FDA, wrapping its application before the end of the year and broadening its research into different tumor types. Delcath has estimated peak sales of an approved system at $745 million.