Delcath Systems Reports Positive Results from Independent Study on Hepatic Perfusion for Uveal Melanoma

Delcath Systems, Inc. (Nasdaq: DCTH), a company specializing in interventional oncology, has announced the findings of a retrospective study published in the Annals of Surgical Oncology. The study, titled “Hepatic and Overall Progression-Free Survival After Percutaneous Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for Metastatic Uveal Melanoma,” was conducted by independent researchers at Moffitt Cancer Center in Tampa, Florida. The study evaluated the performance of Delcath’s HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in treating liver metastases from uveal melanoma.

The study involved 30 patients and found that the HEPZATO KIT offered improved control of liver metastases and enhanced progression-free survival compared to immunotherapy and other liver-directed therapies.

Key findings from the study include:

Overall Survival (OS):
The median overall survival for patients treated with the HEPZATO KIT as a first-line therapy was 22.4 months (N=17), while for those treated as a second-line therapy, it was 18.4 months (N=6).

Hepatic Progression-Free Survival (hPFS):
For patients receiving the HEPZATO KIT as a first-line treatment, the median hepatic progression-free survival was 17.6 months (N=17), compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. When used as a second-line treatment, the median hPFS for the HEPZATO KIT was not reached (N=6), outperforming immunotherapy, which had a median hPFS of 14.7 months (N=5), and other liver-directed therapies with a median hPFS of 7.5 months (N=3).

Progression-Free Survival (PFS):
As a first-line therapy, the median overall PFS for patients treated with the HEPZATO KIT was 15.4 months (N=17), compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. As a second-line therapy, the HEPZATO KIT showed a median PFS of 22.2 months (N=6), compared to 14.7 months (N=5) for immunotherapy and 7.5 months (N=3) for other liver-directed therapies.

Dr. Jonathan Zager, Chief Academic Officer and Director of Regional Therapies at Moffitt Cancer Center, commented on the study's results, emphasizing the importance of melphalan/HDS in treating liver-dominant metastatic uveal melanoma. He highlighted the significant benefits the therapy offers, especially as a first- and second-line treatment, and expressed a commitment to further research combining melphalan/HDS with systemic therapies to improve patient outcomes.

About Delcath Systems, Inc., HEPZATO KIT, and CHEMOSAT:
Delcath Systems, Inc. focuses on treating primary and metastatic liver cancers. Its key products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan, are designed to deliver high-dose chemotherapy to the liver while minimizing systemic exposure and side effects.

In the United States, the HEPZATO KIT is regulated and approved by the FDA as a combination drug and device product. It includes the chemotherapeutic agent melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS isolates hepatic venous blood from the systemic circulation and filters it during melphalan infusion and washout, enabling high-dose melphalan delivery directly to the liver, which can lead to 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 (mUM) with unresectable hepatic metastases affecting less than 50% of the liver or extrahepatic disease amenable to resection or radiation.

In Europe, the HDS is approved as a Class III medical device under the name CHEMOSAT. It is used in percutaneous hepatic perfusion procedures at major medical centers to treat various liver cancers.

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