October 18, 2025 — Leads & Copy — Delcath Systems, Inc. (NASDAQ: DCTH) announced results from the CHOPIN randomized Phase 2 clinical trial, presented at the 2025 European Society of Medical Oncology (ESMO) Annual Congress by Professor Ellen Kapiteijn, MD, from Leiden University Medical Center.
The CHOPIN Trial compared Delcath’s CHEMOSAT® Hepatic Delivery System (HDS) with melphalan alone versus in combination with ipilimumab and nivolumab in patients with metastatic uveal melanoma (mUM). Results showed a significant improvement in progression-free survival and overall survival in the combination group.
Patients were randomized 1:1 to receive percutaneous hepatic perfusion (PHP) alone or in combination with ipilimumab and nivolumab. The combination group showed a one-year progression-free survival rate of 54.7% compared to 15.8% in the PHP group (P<0.001). The one-year overall survival rate was 82.8% in the combination group and 82.2% in the PHP group (P = 0.006).
Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs. 40.5%, P<0.001), but most were manageable. No new safety signals were identified.
Delcath will host a conference call on October 20, 2025, at 8:45 a.m. Eastern Time to discuss the results. The company’s proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.
“The CHOPIN trial clearly demonstrates that adding ipilimumab and nivolumab to PHP is both effective and tolerable. The efficacy results are impressive, especially when considering the treatment regime included only two PHP treatments and did not include nivolumab maintenance. Since many oncologists start systemic therapy first, this approach provides valuable lead time for patient assessment and scheduling PHP, helping to overcome logistical barriers and support broader adoption and near- to medium-term uptake,” said Gerard Michel, Chief Executive Officer of Delcath Systems.
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