Delcath Systems, Inc. announced the publication of updated results from the Phase 1b CHOPIN Trial, conducted at Leiden University Medical Center on the use of the Delcath CHEMOSAT(R) Hepatic Delivery System with Melphalan (CHEMOSAT) in combination with the immune checkpoint inhibitors (ICI) ipilimumab and nivolumab to treat patients with metastatic uveal melanoma with liver metastases. The publication is entitled "Combining Melphalan Percutaneous Hepatic Perfusion with Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma: First Safety and Efficacy Data from the Phase 1b Part of the CHOPIN Trial" and was published in Cardiovascular and Interventional Radiology. Updated CHOPIN Phase 1b Trial Results The goal of the CHOPIN trial is to study the safety and potential synergistic effects of systemic ICI therapy ipilimumab plus nivolumab (IPI+NIVO) when combined with Delcath's proprietary liver-targeted percutaneous hepatic perfusion (PHP) treatment in metastatic uveal melanoma patients.

The just released publication presented updated safety and efficacy results from the Phase 1b portion of the trial which were previously presented in June 2022 at the American Society of Clinical Oncology Annual Meeting. The Phase 1b portion of the trial enrolled seven patients each of which were treated with two courses of PHP (melphalan 3mg/kg, max 220 mg per cycle) combined with four courses IPI+NIVO escalating the dosing from 1mg/kg each IPI+NIVO (cohort 1) to IPI 1mg/kg + NIVO 3mg/kg (cohort 2). As previously reported, the Best Overall Response included 1 complete response, 5 partial responses and 1 stable disease accounting for an Objective Response Rate of 85.7% and a Disease Control Rate of 100%.

At the cut-off date of November 15, 2022, the median follow-up was 29.1 months (range 8.9 -- 30.2), the median PFS was 29.1 months (95% CI 11.9 -- 46.3) and the median duration of response was 27.1 months (range 7.4 -- 28.5).