Delcath Systems (DCTH) investor relations material

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.