RTTNews | Mar 31, 2021 07:53AM EDT

07:53 Wednesday, March 31, 2021 (RTTNews.com) - 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.

Read the original article on RTTNews ( https://www.rttnews.com/3181673/delcath-systems-reports-positive-preliminary-results-from-phase-3-focus-trial-of-hepzato.aspx)

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