Delcath Systems Announces Publication of 10-Year Single-Center Experience with Percutaneous Hepatic Perfusion in Liver-Dominant Metastatic Uveal Melanoma
Delcath Systems Announces Publication of 10-Year Single-Center Experience with Percutaneous Hepatic Perfusion in Liver-Dominant Metastatic Uveal Melanoma
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percutaneous hepatic perfusionmedical
Percutaneous hepatic perfusion is a medical procedure that delivers high doses of cancer-fighting medicine directly to the liver through a small tube inserted into a blood vessel. It matters because it targets liver tumors more precisely, often with fewer side effects, helping to control cancer that has spread to the liver.
melphalanmedical
Melphalan is a strong medicine used to treat certain types of cancer, especially blood cancers like multiple myeloma and lymphoma. It works by stopping cancer cells from growing and dividing, helping to control the disease. Because of its power, doctors use it carefully to target cancer while trying to protect healthy cells.
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Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
hazard ratiomedical
A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.
ECOG-PSmedical
ECOG-PS (Eastern Cooperative Oncology Group Performance Status) is a scale doctors use to measure how well a person with a serious illness, like cancer, can carry out daily activities such as walking, dressing, or eating. It helps determine how healthy the patient is and guides doctors in choosing the best treatment options.
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Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.
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 retrospective study by leading interventional radiologists and oncologists from Asklepios Hospital Barmbek in Hamburg, Germany. The study, titled “Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience,” was published in the journal Cancers and reports outcomes from 38 consecutive patients with liver-dominant metastatic uveal melanoma (mUM) who underwent 99 procedures using Delcath’s CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP). The article highlights the procedure’s safety and efficacy, demonstrating a median overall survival (OS) of 29.1 months from the first PHP treatment, with improved outcomes associated with additional treatment cycles.
“The publication of this 10-year experience in Cancers underscores the significant clinical evidence supporting the use of PHP as an effective liver-directed therapy for patients with liver-dominant metastatic uveal melanoma,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “These results from a high-volume specialized center show a median OS approaching 2.5 years, surpassing prior reports and reinforcing the potential survival benefits of treatment with repeated PHP cycles. We are pleased to see this data add to the collection of research supporting HEPZATO KIT and CHEMOSAT, which aligns with our commitment to advancing treatment options in interventional oncology.”
The retrospective study synthesizes data from consecutive patients treated between April 2014 and March 2024, demonstrating safety and efficacy of CHEMOSAT in a real-world setting. Key highlights include:
Median OS of 29.1 months (95% CI: 18.4–38.9 months) from the first PHP treatment, with 1-, 2-, and 3-year OS rates of 79.5%, 53.2%, and 28.5%, respectively
Numerically improved median OS with ≥3 PHP cycles (29.8 months) versus ≤2 cycles (21.4 months; p=0.058), with each additional cycle associated with a ~40% reduction in risk of death (HR=0.414)
No treatment-related deaths, with procedure-related adverse events graded ≥2 occurring in 10.5% of patients
Patient population with ECOG-PS 0-1, ≤70% liver involvement, and limited extrahepatic disease, reflecting appropriate selection for PHP
Support for institutional experience and volume as factors in optimizing outcomes, providing a reference for novel mUM management strategies
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 retrospective analysis 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.
