Delcath Systems announced that the complete results of its investigator‑initiated CHOPIN Phase 2 study have been published in The Lancet Oncology. The randomized trial enrolled 76 patients with metastatic uveal melanoma and compared percutaneous hepatic perfusion (PHP) with melphalan alone to PHP combined with the immune checkpoint inhibitors ipilimumab and nivolumab.
The combination arm produced a one‑year progression‑free survival rate of 54.7% versus 15.8% in the PHP‑alone arm, and a median overall survival of 23.1 months compared with 19.6 months. Overall response rates were 76.3% for the combination versus 39.5% for PHP alone, underscoring the synergistic benefit of adding checkpoint inhibition to liver‑directed therapy.
Safety data showed grade 3 or higher adverse events in 82% of patients receiving the combination versus 41% in the PHP‑alone group, but the events were largely manageable with standard supportive care. A single treatment‑related death occurred in the combination cohort, and no new safety signals were identified.
The publication validates Delcath’s core hepatic delivery technology and supports the company’s strategy to expand into larger liver‑dominant indications such as metastatic colorectal and breast cancers. Strong efficacy data are expected to reinforce physician confidence, facilitate reimbursement discussions, and accelerate adoption of the HEPZATO KIT in the United States and internationally. Delcath has already secured New Technology Add‑on Payment status from CMS, effective October 1, 2024, which helps cover costs for eligible Medicare inpatients.
Financially, Delcath reported record revenue of $85.2 million for 2025, up from $37.2 million in 2024, and a net income of $2.7 million after a net loss of $26.4 million in 2024. Gross margins were 86% for the full year. For 2026, the company projects total revenue of at least $100 million, with gross margins between 84% and 87%, and plans to expand its treatment‑center footprint from 28 to 40 by year‑end.
CEO Gerard Michel highlighted the trial’s impact, noting that the data “reinforce the synergistic potential of combining PHP with immunotherapy, showing superior PFS and OS and deeper, more durable responses.” He added that the results “provide a strong foundation for exploring this paradigm in other liver‑dominant cancers.”
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