Delcath Systems Reports Positive Preliminary Results From Phase 3 FOCUS Trial Of HEPZATO

(RTTNews) - Delcath Systems, Inc. (DCTH) reported positive top-line preliminary results from the phase 3 FOCUS trial of HEPZATO KIT in patients with liver dominant metastatic ocular melanoma. Based on the preliminary analysis, the Independent Review Committee assessed Overall Response Rate of 29.2% in the Intent to Treat population which exceeded the predefined success criteria (21.0%) for the primary Overall Response Rate endpoint.

"While the analysis is preliminary and the trial is still ongoing, these results strongly suggest that the final FOCUS dataset will demonstrate a significantly improved benefit-risk profile compared with Best Alternative Care that could form the basis of our NDA resubmission to the FDA," said Gerard Michel, CEO of Delcath.