Breakthrough study reveals Delcath Systems’ therapy doubles survival for uveal melanoma patients

Delcath Systems, Inc. (Nasdaq: DCTH), a pioneering company in interventional oncology, has announced promising results from a recent independent study evaluating its liver-directed therapy for patients with uveal melanoma.

The study, published in the journal Therapeutic Advances in Medical Oncology, is titled “Melanoma-specific survival of patients with uveal melanoma and liver metastases diagnosed between 2005 and 2021.” It was conducted by investigators from the University of Tübingen, Germany. The research highlights that liver-directed therapies, including Delcath’s CHEMOSAT Hepatic Delivery System, substantially enhance melanoma-specific survival (MSS) compared to first-line systemic therapies for patients with liver metastases from uveal melanoma.

Key Findings from the Study

The retrospective clinical study analyzed data from 167 patients diagnosed with metastatic uveal melanoma between 2005 and 2021. Notably, patients who received first-line liver-directed therapy, including Delcath’s CHEMOSAT system, demonstrated a median MSS of 28 months. In contrast, those who were treated with first-line systemic therapy had a median MSS of just 10 months.

Further analysis revealed a positive trend over time for liver-directed therapies. Patients diagnosed with liver metastases between 2016 and 2021 who were treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months. This is a significant improvement compared to the median MSS of 20 months observed in patients treated between 2005 and 2015.

Specifically, during the period from 2005 to 2015, 33 patients received liver-directed therapy, with 8 receiving CHEMOSAT. Conversely, from 2016 to 2021, 56 patients received liver-directed therapy, including 30 who were treated with CHEMOSAT.

Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented on the findings: “We are encouraged by the results of this independent study, which affirm the vital role of liver-directed therapies in the first-line setting, including our CHEMOSAT system, for treating patients with liver metastases from uveal melanoma.”

About Delcath Systems, Inc., HEPZATO KIT, and CHEMOSAT

Delcath Systems, Inc. is dedicated to advancing interventional oncology treatments for liver cancers. The company’s 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 systems are designed to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and side effects.

In the United States, the HEPZATO KIT is approved by the FDA as a combination drug and device product for treating adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver or extrahepatic disease that is amenable to resection or radiation. In Europe, the CHEMOSAT Hepatic Delivery System is approved as a Class III medical device for conducting percutaneous hepatic perfusion procedures at major medical centers.