Delcath Systems Announces Publication of Expert Narrative Review on Percutaneous Hepatic Perfusion for Liver Metastases from Uveal Melanoma

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), (“Delcath” or the “Company”) an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of a narrative review by leading interventional radiologists and oncologists from multiple institutions. The review, titled “Treatment of Liver Metastases from Uveal Melanoma with Percutaneous Hepatic Perfusion,” was published in the Journal of Vascular and Interventional Radiology (JVIR) and provides a comprehensive overview of percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s HEPZATO KIT™. The article highlights PHP’s rationale, technique, patient selection, clinical outcomes, and future research directions, emphasizing its role as an FDA-approved liver-directed therapy for unresectable hepatic metastases from uveal melanoma (UM) with limited extrahepatic disease.

“The publication of this expert narrative review in JVIR features the growing clinical evidence and consensus supporting the use of PHP as a key treatment option for patients with liver-dominant metastatic uveal melanoma,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “By consolidating insights from leading specialists, this review reinforces the value of HEPZATO KIT in achieving meaningful tumor responses and survival benefits while preserving quality of life. We are encouraged by the highlighted potential for broader applications and combinations with systemic therapies, which align with our ongoing efforts to advance interventional oncology.”

The narrative review synthesizes data from prospective and retrospective studies from leading centers in the US and Europe, collectively demonstrating objective response rates of 36%-72%, median overall survival of 15-20 months, and disease control rates up to 89%. Key highlights include:

• PHP’s suitability for multifocal, bilobar UM liver metastases, delivering high-dose chemotherapy with extracorporeal filtration to minimize systemic toxicity
• Short-stay hospital admissions with discharge within 24 hours
• Advantages over other liver-directed therapies, such as reduced risk of hepatic fibrosis compared to radioembolization in whole-liver treatments
• Quality of life data showing no long-term decline, with scores returning to baseline by Day 28 post-procedure
• Ongoing research into immunotherapy combinations and expansion to other metastatic cancers like breast and colorectal

The article is available here.

About Delcath Systems, Inc., HEPZATO KIT, and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary HDS. The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.

In Europe, the device-only configuration of the HDS is regulated as a Class Ill medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.

Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by Delcath or on its behalf. This press release contains forward-looking statements, including statements regarding the potential of CHEMOSAT Hepatic Delivery System and HEPZATO KIT to improve outcomes for patients with metastatic uveal melanoma; statements regarding the potential synergy seen in the reported review being transferable to other cancers with liver-dominant disease. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Factors that may cause such differences include, but are not limited to, those discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Delcath undertakes no obligation to publicly update or revise these forward-looking statements except as required by applicable law.