Delcath Systems Reports Positive Results from Independent Study on Liver Therapy for Uveal Melanoma

Delcath Systems, Inc. (Nasdaq: DCTH), a company specializing in interventional oncology, has published a study in the journal "Therapeutic Advances in Medical Oncology." This study, titled “Melanoma-specific survival of patients with uveal melanoma and liver metastases diagnosed between 2005 and 2021,” was carried out by researchers from the University of Tübingen in Germany. It shows that first-line liver-directed therapies, including Delcath’s CHEMOSAT® Hepatic Delivery System, can significantly improve melanoma-specific survival (MSS) for patients with liver metastases arising from uveal melanoma, compared to first-line systemic therapies.

Key insights from the study reveal positive trends in survival rates when using first-line liver-directed therapies. The researchers analyzed data from 167 patients diagnosed with metastatic uveal melanoma between 2005 and 2021. Among the patients who received first-line liver-directed therapy (N=89), the median MSS was recorded at 28 months. This is a substantial improvement compared to the 10 months median MSS for those who received first-line systemic therapy (N=45).

The study also compared outcomes over time for those receiving first-line liver-directed therapies. Patients diagnosed between 2016 and 2021 (N=56) who were treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months. This is compared to a median MSS of 20 months for patients diagnosed between 2005 and 2015 (N=33) who also received first-line liver-directed therapy. Specifically, during the 2005-2015 period, 33 patients received liver-directed therapy, with 8 of them treated using CHEMOSAT. Meanwhile, in the 2016-2021 period, 56 patients received liver-directed therapy, with 30 of them receiving CHEMOSAT.

Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, expressed optimism about the study results. He emphasized that these findings underscore the significant impact of liver-directed therapies in the first-line setting, including their own CHEMOSAT system, for treating patients with liver metastases from uveal melanoma.

Delcath Systems, Inc. focuses on the development and commercialization of treatments for primary and metastatic liver cancers. Their key products include the HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and the CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP). These products aim to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and related side effects.

In the United States, HEPZATO KIT is classified as a combination drug and device product. It is approved for sale as a drug by the FDA and involves the use of melphalan along with Delcath's proprietary Hepatic Delivery System (HDS). The HDS isolates hepatic venous blood from systemic circulation while filtering hepatic venous blood during melphalan infusion and washout. This method allows for the localized delivery of a high dose of melphalan, potentially inducing a significant tumor response with minimal liver toxicity and reduced systemic exposure. The HEPZATO KIT is approved in the United States for treating adult patients with metastatic uveal melanoma who have unresectable liver metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to certain areas that are treatable with resection or radiation.

In Europe, the HDS is recognized as a Class III medical device and is marketed under the name CHEMOSAT Hepatic Delivery System for Melphalan. This device has been utilized in various major medical centers to conduct percutaneous hepatic perfusion procedures, treating a diverse range of liver cancers.

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