March 3, 2026 — Leads & Copy —
Delcath Systems, Inc. (Nasdaq: DCTH) announced the publication of full results from the CHOPIN randomized Phase 2 clinical trial, which evaluated a combination therapy for metastatic uveal melanoma. The trial, led by Professor Ellen Kapiteijn, MD, from Leiden University Medical Center, assessed percutaneous hepatic perfusion (PHP) combined with ipilimumab and nivolumab. The findings, published in The Lancet Oncology, expand on positive topline results presented at the European Society for Medical Oncology (ESMO) Congress in October 2025.
The study randomized 76 patients with metastatic uveal melanoma, with 38 patients in each arm. One group received PHP with melphalan using Delcath’s CHEMOSAT® Hepatic Delivery System (HDS) alone, while the other group received the same PHP treatment in combination with ipilimumab plus nivolumab. Patients in both arms received two PHP treatments at weeks 1 and 7. The combination arm also received ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) in weeks 0, 3, 6, and 9, without maintenance therapy.
Key findings from the intention-to-treat population include a 1-year progression-free survival (PFS) rate of 54.7% in the combination arm compared to 15.8% in the PHP-alone arm (adjusted HR 0.34). Median PFS was 12.8 months versus 8.3 months, respectively. The combination therapy also showed improved Overall Survival (OS), with a median of 23.1 months compared to 19.6 months (HR 0.39). The 2-year OS rate was 49.6% versus 22.1%. The Objective Response Rate (ORR) was 76.3% in the combination arm versus 39.5%, with a Complete Response (CR) rate of 13% versus 3%.
The study noted a higher incidence of Grade 3 or higher treatment-related adverse events in the combination arm (82%) compared to the PHP-alone arm (41%). The most common events included thrombocytopenia, leukopenia, γ-glutamyl transferase increase, and anemia. Most events were manageable with standard supportive care, and no new safety signals were identified. One treatment-related death (immune-related triple M syndrome) occurred in the combination arm.
According to Professor Kapiteijn, the publication reinforces the synergistic potential of combining PHP with immunotherapy, resulting in superior PFS and OS, enhanced hepatic control, and more durable responses.
Gerard Michel, Chief Executive Officer of Delcath Systems, stated that the publication validates the efficacy of combining their liver-directed PHP therapy with immune checkpoint inhibition, potentially increasing adoption by physicians and patients. He also noted the potential to explore this treatment approach in other liver-dominant cancers.
Delcath Systems, Inc. is focused on treating primary and metastatic liver cancers through its HEPZATO KIT and CHEMOSAT Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP).
HEPZATO KIT, a combination drug and device product approved by the FDA, delivers high-dose chemotherapy to the liver while controlling systemic exposure. CHEMOSAT, approved in Europe, is used in percutaneous hepatic perfusion procedures to treat various liver cancers.
Source: Delcath Systems, Inc.
