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Delcath Systems (DCTH) investor relations material
Delcath Systems Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.CHOPIN trial design and objectives
The CHOPIN phase II trial randomized 76 patients with metastatic uveal melanoma to receive either percutaneous hepatic perfusion (PHP) alone or in combination with ipilimumab and nivolumab over nine weeks.
The primary endpoint was one-year progression-free survival; secondary endpoints included safety, best overall response rate, overall survival, and hepatic progression-free survival.
76 patients were randomized 1:1 to receive either PHP alone or PHP plus immune checkpoint inhibitors.
Key efficacy results
One-year progression-free survival was 54.7% for the combination group versus 15.8% for PHP alone; median overall survival was 23.1 vs. 19.6 months; best overall response rates were 76.3% vs. 39.5%.
One-year overall survival was 82.8% for the combination group and 82.2% for PHP alone; two-year overall survival was 49.6% versus 22.1%.
All efficacy advantages for the combination were statistically significant.
Safety and tolerability
Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs. 40.5%) but were generally manageable with standard care.
No new safety signals were identified; adverse event profiles were consistent with known effects of PHP and checkpoint inhibitors.
The trial did not include additional PHP treatments beyond two cycles or nivolumab maintenance therapy.
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