Delcath Systems Highlights Clinical Program Presentations at ESMO Congress 2026 and Independent Data on Percutaneous Hepatic Perfusion in Liver-Dominant Metastatic Uveal Melanoma

The independent CHEMOSAT findings come from a retrospective cohort of 12 patients, rather than a randomized comparison.

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QUEENSBURY, N.Y.--(BUSINESS WIRE)-- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced presentations related to its clinical development programs at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain. The Company also highlighted the publication of an independent, investigator-led analysis of percutaneous hepatic perfusion (PHP) with melphalan using the CHEMOSAT® Hepatic Delivery System in patients with liver-dominant metastatic uveal melanoma (mUM).

ESMO Congress 2026 Presentation Details

Company Sponsored Trial-in-Progress Poster Presentation
Title: DELUMA: An Open-Label, Randomized Phase II Study of Melphalan/HDS Induction Followed by Standard Therapy vs Standard Therapy Alone in Patients with Liver-Dominant Metastatic Breast Cancer
Abstract Number: 58TiP
Presenter: Heather McArthur, MD, MPH; UT Southwestern Medical Center, Global Principal Investigator
Date/Time: Saturday, October 24, 2026, 12:00 CEST
Location: Poster Area, Hall 5, IFEMA Madrid

“Meet the Investigators” Session
Date/Time: Saturday, October 24, 2026, 16:30–17:00 CEST
Location: Valencia Auditorium

• Del-Liver Phase 2 trial in metastatic colorectal cancer – update presented by Global Principal Investigator Marwan Fakih, MD, City of Hope
• Deluma Phase 2 trial in metastatic breast cancer – update presented by Global Principal Investigator Heather McArthur, MD, MPH, UT Southwestern Medical Center

The session will conclude with an open Q&A discussion.

Poster Presentation – Independent Investigator
Title: Liver-metastatic uveal melanoma comparison: melphalan hepatic delivery (PHP) + ipilimumab/nivolumab versus tebentafusp
Abstract Number: 2135P
Presenter: Cato Boreel, Dutch Institute for Clinical Auditing (Dutch Melanoma Treatment Registry)
Session Type: Poster
Date/Time: Saturday, October 24, 2026, 12:00 CEST
Location: Poster Area, Hall 5, IFEMA Madrid
Summary: Compares regional treatment (melphalan hepatic delivery/PHP) plus ipilimumab/nivolumab with systemic tebentafusp in patients with liver-metastatic uveal melanoma.

Independent Analysis of CHEMOSAT PHP in Liver-Dominant Metastatic Uveal Melanoma

Independent investigators from St Vincent’s University Hospital in Dublin, Ireland published a retrospective analysis of patients with liver-dominant mUM who were referred to University Hospital Southampton for chemosaturation with percutaneous hepatic perfusion (CS-PHP) between 2019 and 2026. The abstract, “Outcomes and safety of chemosaturation with percutaneous hepatic perfusion (CS-PHP) in liver-dominant metastatic uveal melanoma: Impact of molecular profiling on survival” (Abstract 119P), appears in ESMO Open, Volume 11, Supplement 7 (September 2026), and is available here.

Key findings (retrospective cohort; N=12):

• Patients received a median of 3 CS-PHP cycles (median age 58 years).
• Objective response rate (ORR) was 66.7% and disease control rate (DCR) was 75% per RECIST 1.1.
• Median hepatic progression-free survival was 18.4 months and median overall survival was 28 months.
• Serious adverse events were reported in 3 patients, including pulmonary embolism and one procedural hemorrhage; no treatment-related deaths occurred.
• In exploratory analyses, BAP1 loss and monosomy 3 (each identified in 6 of 12 patients) were associated with shorter survival.

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 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 Hepatic Delivery System (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 III 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 possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to other cancers with liver-dominant disease; statements regarding the potential of CHEMOSAT Hepatic Delivery System and HEPZATO KIT to improve outcomes for patients with metastatic uveal melanoma and other cancers with liver-dominant disease; statements regarding the potential to drive increased adoption of HEPZATO KIT; statements regarding Delcath’s commitment to raising awareness of the innovative approach taken in the CHOPIN Trial, and accelerating the referral of patients to treatment sites; and statements regarding Delcath’s continued growth and leadership in liver-directed oncology, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

This release contains forward-looking statements, including statements regarding the expected release of clinical trial results, which are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, delays in the presentation of the data, or other unforeseen issues relating to the release of the clinical trial results. For a detailed discussion of these and other risks, please refer to Delcath’s filings with the SEC.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261019169467/en/

Investor Relations Contact:
ICR Healthcare
investorrelations@delcath.com

Source: Delcath Systems, Inc.

Key Terms

percutaneous hepatic perfusion medical

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.

objective response rate medical

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

disease control rate medical

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

recist 1.1 medical

RECIST 1.1 is a standardized set of rules used in cancer clinical trials to measure how solid tumors respond to treatment by tracking changes in size on medical scans. Think of it as a consistent ruler and scorecard that tells doctors and regulators whether a drug is shrinking tumors, keeping them stable, or allowing them to grow. Investors care because RECIST-based results are common primary endpoints that influence regulatory decisions, trial success, and a therapy’s commercial prospects.

hepatic progression-free survival medical

Hepatic progression-free survival is a clinical trial measure that tracks how long patients go without their liver tumors growing or new liver lesions appearing after treatment. Think of it as the time a treatment keeps disease in the liver from getting worse, measured from the start of therapy to documented liver progression or death. Investors watch this endpoint because it indicates a drug's effectiveness against liver disease and can influence regulatory decisions, market potential, and revenue forecasts.