- 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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