Delcath Systems Announces Phase 3 FOCUS Trial Subgroup Analyses for Hepzato Kit in Metastatic Uveal Melanoma
Summary:
Delcath Systems (DCTH) published subgroup analyses from its phase 3 FOCUS trial evaluating Hepzato Kit in metastatic uveal melanoma (mUM) patients. The Journal of Cancer Research and Clinical Oncology study demonstrates consistent tumor response across age, sex, and prior therapy subgroups, with superior outcomes in patients with lower hepatic tumor burden. As the only FDA-approved liver-directed therapy for unresectable mUM, these findings help clinicians identify optimal candidates for treatment. Results show 57.6% of objective responses occurred within the first two treatment cycles with no cumulative toxicity observed.
What This Means for You:
- Treatment Selection: Oncologists should prioritize patients with tumor burden below median levels for improved ORR (overall response rate) and PFS (progression-free survival)
- Response Monitoring: Track early treatment cycles closely – most responses appear by Cycle 2, but 33% emerge in Cycles 4-6
- Safety Protocol: Maintain standard adverse event monitoring as toxicity profiles remain consistent across subgroups
- Market Implications: Delcath’s positioning strengthens in liver-directed therapies – monitor Q2 2024 commercialization updates for investment decisions
Original Post:
Delcath Systems (DCTH) announced the publication of results from subgroup analyses of the phase 3 FOCUS study in the Journal of Cancer Research and Clinical Oncology. The analysis assessed Hepzato Kit efficacy and safety in mUM patient subgroups, including age, sex, tumor burden, and prior therapies. Key findings showed significantly higher ORR (53.3% vs 23.9%) and longer median PFS (9.1 vs 5.7 months) for patients with tumor burden below the median. Median OS reached 21.7 months for low tumor burden patients versus 16.2 months for high burden. No treatment-related deaths occurred during the study of 91 patients.
Extra Information:
• FDA Approval Documentation – Details Hepzato’s breakthrough designation and approval criteria
• FOCUS Trial Protocol – Original study design and primary endpoints
• Patient Education Portal – Delcath’s resource explaining liver-directed therapy mechanisms
People Also Ask About:
- What is metastatic uveal melanoma (mUM)? A rare ocular cancer with 85% liver metastasis rate and median OS of 12-18 months.
- How does the Hepzato Kit work? Delivers melphalan via percutaneous hepatic perfusion (PHP) system with hemofiltration.
- When did Hepzato receive FDA approval? August 14, 2023 for unresectable hepatic-dominant mUM.
- What were median PFS/OS in FOCUS? 9.1 months PFS and 20.5 months OS in overall cohort.
- Is Hepzato covered by insurance? Commercial availability expected mid-2024 following CMS reimbursement discussions.
Expert Opinion:
“These subgroup analyses validate precision patient selection for PHP therapy,” says Dr. Jonathan Zager, surgical oncologist at Moffitt Cancer Center. “The tumor burden stratification provides actionable thresholds for maximizing therapeutic benefit. As hepatic metastasis drives mUM mortality, these data reinforce Hepzato’s role in the liver-directed treatment arsenal while highlighting the need for combinatorial approaches against extrahepatic disease.”
Key Terms:
- Percutaneous Hepatic Perfusion therapy for metastatic uveal melanoma
- Phase 3 FOCUS trial subgroup survival analysis
- Hepzato Kit FDA approval status MELPHALAN/HDS
- Liver-directed treatment tumor burden thresholds
- Objective response rate PHP chemotherapy delivery
- Metastatic ocular melanoma hepatic progression
- Delcath Systems DCTH investment clinical catalysts
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