Based on Preliminary Data, FOCUS Trial Achieves Prespecified Success Threshold
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NEW YORK, March 31, 2021 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced positive top-line preliminary results from the company's Phase 3 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:
- 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