Delcath Systems Inc DCTH has announced results from the Phase 3 FOCUS study of Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma.
- The FOCUS study's intent-to-treat (ITT) population included 102 subjects. Of the ITT group, 91 evaluable patients were administered at least one study treatment.
- The ITT analysis resulted in an objective response rate (ORR) of 31.4%, including 6.9% of patients with a complete response (CR) for Hepzato treatment.
- The median duration of response was 14 months, with over half of responders continuing to be monitored for progression events. The disease control rate (DCR) was 65.7%.
- While overall survival data continues to mature, a Hazard Ratio (HR) analysis of survival at 12-months yielded a statistically significant advantage for Hepzato over a Best Alternative Care (BAC) arm (HR=0.37).
- ORR of 35.2% versus 12.5% for the BAC arm, DCR of 73.6% versus 37.5% for patients in the BAC arm, and Median Progression-Free Survival of 9.03 months versus 3.12 months.
- Related Link: Delcath Systems' Hepzato Achieves 44% Best Overall Response Compared to Best Alternative Care in Eye Cancer.
- As of this analysis, survival at 12-months in the evaluable patients was 75% in the Hepzato arm versus 47% for BAC (HR=0.37).
- The most commonly reported treatment-emergent serious adverse events were anemia (29.7%), thrombocytopenia (26.4%), and neutropenia (19.8%), which were well-manageable.
- 5.3% of patients experienced treatment-emergent serious cardiac adverse events. In all cases, the events were resolved with no ongoing complications. There were no treatment-related deaths in the trial.
- Price Action: DCTH shares are down 6.28% at $9.10 during the market session on the last check Thursday.
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