Delcath Systems, Inc. announces positive preliminary results from phase III FOCUS trial of HEPZATO in patients with metastatic ocular melanoma.

Delcath Systems, Inc. announced positive top-line preliminary results from the company's Phase III FOCUS trial of HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma (mOM). Based on the preliminary analysis of 87% of enrolled patients using prespecified analyses the Independent Review Committee (IRC) assessed Overall Response Rate (ORR) of 29.2% [95% Confidence Interval (CI): 20.1, 39.8] in the Intent to Treat (ITT) population which exceeded the predefined success criteria (21.0%) for the primary ORR endpoint. Based on predefined exploratory analyses, evaluable patients in the HEPZATO arm had a statistically significant improvement over Best Alternative Care (BAC) in the following prespecified endpoints: i. ORR of 32.9% [95% CI: 22.8, 44.4] versus 13.8% [95% CI: 3.9, 31.7] for the BAC arm (Chi-square P<0.05). ii. median progression free survival of 9.0 months 95 ci: 6.211.8 versus 3.1 months 95 ci: 2.7 5.7 for the bac arm hr="0.41;" p><0.001). iii. disease control rate of 70.9 95 ci: 59.6 80.6 versus 37.9 95 ci: 20.7 57.7 for patients in the bac arm p><0.002). iv. duration of response and overall survival are not yet evaluable. since not all patients were evaluable for all time points these preliminary analyses may change as data matures. the safety profile in this trial was consistent with the safety profile of php treatment described in european single-center and multi-center publications with no new safety signals observed in this patient population. in the hepzato safety population of 94 patients 38 patients 40.4 experienced a treatment-emergent serious adverse event. the most commonly reported treatment-emergent serious adverse events were thrombocytopenia 14.9 of patients neutropenia 10.6 of patients and leukopenia 4.2 of patients which were well-manageable. 5 of patients experienced treatment-emergent serious cardiac adverse events. in all cases the events resolved with no ongoing complications. there were no treatment-related deaths in the trial..>