WASHINGTON (dpa-AFX) - 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.
Copyright RTT News/dpa-AFX
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