Delcath Systems' Hepzato Achieves 44% Best Overall Response Compared to Best Alternative Care in Eye Cancer

Delcath Systems Inc DCTH has announced positive preliminary efficacy results from its FOCUS Phase 3 trial evaluating Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma.
Data were presented at the American Society of Clinical Oncology Annual Meeting.
Data showed that 44% of evaluable patients in the Hepzato arm had a 30% or greater reduction in target tumor lesions at one or more time points versus 17% for patients enrolled in the Best Alternative Care (BAC) arm.
Hepzato Kit, percutaneous hepatic perfusion (PHP) system showed preliminary overall response rate nearly three times better versus BAC arm in both treated (32.9% vs. 13.8%) and preliminary intent to treat - ITT (29.2% vs. 10.3%).
The preliminary disease control rate was approximately doubled in favor of PHP vs. BAC in both treated (71% vs. 38%) and preliminary ITT (63% vs. 29%).
Preliminary progression-free survival was nearly tripled in PHP vs. BAC (9.03 months vs. 3.06 months).
Data also covered previously announced preliminary data showing an overall response rate of 29.2% with a 95% confidence interval lower bound of 20%. Given the magnitude by which the lower bound exceeds the 8.3% prespecified threshold for success.
As 57.1% of the subjects in the BAC arm were able to crossover to the PHP arm, this crossover design of the study, the overall survival benefit was confounded.
On the safety front, the most common treatment-related severe adverse events were thrombocytopenia (14.9%), neutropenia (10.9%), and leukopenia (4.2%).
See the slide presentation here.
Price Action: DCTH shares are up 3.21% at $11.05 during the market session on the last check Monday.

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