Exhibit 99.1
Delcath Systems, Inc. Announces Positive Results from Independent Study on Liver-Directed Therapy for Uveal Melanoma Patients
NEW YORK - August 28, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the “Company” or “Delcath”), an interventional oncology company focused on
the treatment of primary and metastatic cancers of the liver, today announced the publication of a clinical study in the journal Therapeutic Advances in Medical Oncology. The publication, entitled “Melanoma-specific survival of patients with
uveal melanoma and liver metastases diagnosed between 2005 and 2021”, was based on an independent retrospective clinical study conducted by investigators from the University of Tübingen, Germany. The study demonstrates that first-line
liver-directed therapies, including Delcath’s CHEMOSAT® Hepatic Delivery System, significantly improve melanoma-specific survival (MSS) in patients with liver metastases from uveal
melanoma, compared to first-line systemic therapies.
Key Findings from the Study:
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Positive Trends in Survival With First-Line Liver-Directed Therapies: The study analyzed 167
patients diagnosed with metastatic uveal melanoma between 2005 and 2021. Among those receiving first-line liver-directed therapy (N=89), the median MSS was 28 months, compared to 10 months for patients who received first-line systemic therapy
(N=45). |
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Comparison of Outcomes Over Time with First-Line Liver-Directed Therapies: The study found that
patients diagnosed with liver metastases between 2016 and 2021 (N=56) and treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months. In comparison, patients diagnosed between 2005 and 2015 (N=33) who received
first-line liver-directed therapy had a median MSS of 20 months. |
During the 2005-2015 period, 33 patients received
liver-directed therapy, with 8 of those receiving CHEMOSAT. In the 2016-2021 period, 56 patients received liver-directed therapy, with 30 of those receiving CHEMOSAT.
Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented, “We are encouraged by the findings from this independent study, which
reinforce the critical role of liver-directed therapies in the first-line setting, including our CHEMOSAT system, in treating patients with liver metastases from uveal melanoma.”
The publication 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 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