Delcath Systems Announces Poster Presentation at the 2024 ESMO Congress

Rhea-AI Summary

Delcath Systems (Nasdaq: DCTH) announced a poster presentation at the 2024 ESMO Congress in Barcelona, Spain. The presentation, scheduled for September 14, 2024, will showcase data from the FOCUS Phase 3 study, focusing on the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients with unresectable metastatic uveal melanoma (mUM).

The poster, titled 'Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results,' will highlight the treatment's effectiveness across six patient subgroups. This presentation represents an important opportunity for Delcath to share its research findings with the international oncology community at one of the field's most prestigious conferences.

Positive

• Presentation of Phase 3 study results at a major oncology conference (ESMO)
• Focus on efficacy data for Melphalan/HDS in treating unresectable metastatic uveal melanoma
• Subgroup analysis potentially demonstrating broad applicability of the treatment

Negative

• None.

NEW YORK--(BUSINESS WIRE)-- 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, announced today that it will present data from its FOCUS Phase 3 study at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting, which convenes from September 13-17, 2024, in Barcelona, Spain.

Poster Presentation Details

Title: Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results
Date: September 14, 2024
Time: 9:00 am
Location: Hall 6
Poster number: 1127P

The presentation will highlight the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in patients across six subgroups with unresectable metastatic uveal melanoma (mUM).

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240820116749/en/

Investor Relations:

ICR Westwicke

investorrelations@delcath.com

Source: Delcath Systems, Inc.

FAQ

What will Delcath Systems (DCTH) present at the 2024 ESMO Congress?

Delcath Systems will present a poster titled 'Subgroup Analysis of FOCUS Phase 3 Trial Efficacy Results,' showcasing data on the efficacy of Melphalan/Hepatic Delivery System in patients with unresectable metastatic uveal melanoma across six subgroups.

When and where is Delcath's (DCTH) poster presentation at the ESMO Congress?

The poster presentation is scheduled for September 14, 2024, at 9:00 am in Hall 6 of the ESMO Congress venue in Barcelona, Spain. The poster number is 1127P.

What is the focus of Delcath Systems' (DCTH) FOCUS Phase 3 study?

The FOCUS Phase 3 study focuses on the efficacy of the Melphalan/Hepatic Delivery System (Melphalan/HDS) in treating patients with unresectable metastatic uveal melanoma (mUM).

What type of cancer does Delcath Systems (DCTH) target with its Melphalan/HDS treatment?

Delcath Systems' Melphalan/HDS treatment targets unresectable metastatic uveal melanoma (mUM), a type of cancer that originates in the eye and spreads to other parts of the body, particularly the liver.