Delcath Systems, Inc. Announces Positive Results from Independent Study on Liver-Directed Therapy for Uveal Melanoma Patients

Rhea-AI Summary

Delcath Systems, Inc. (Nasdaq: DCTH) announced positive results from an independent study on liver-directed therapy for uveal melanoma patients. The study, published in Therapeutic Advances in Medical Oncology, showed that first-line liver-directed therapies, including Delcath's CHEMOSAT® Hepatic Delivery System, significantly improved melanoma-specific survival (MSS) in patients with liver metastases from uveal melanoma.

Key findings include:

• Patients receiving first-line liver-directed therapy (N=89) had a median MSS of 28 months, compared to 10 months for those receiving first-line systemic therapy (N=45)
• Patients diagnosed between 2016-2021 and treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months, compared to 20 months for those diagnosed between 2005-2015

Positive

• First-line liver-directed therapies, including CHEMOSAT, significantly improved melanoma-specific survival in uveal melanoma patients with liver metastases
• Median MSS for patients receiving first-line liver-directed therapy was 28 months, compared to 10 months for systemic therapy
• Patients treated with liver-directed therapy, including CHEMOSAT, between 2016-2021 showed improved MSS of 30 months compared to 20 months in 2005-2015

Negative

• None.

Insights

Medical Research Analyst

This independent study provides compelling evidence for the efficacy of liver-directed therapies, particularly Delcath's CHEMOSAT® system, in treating uveal melanoma liver metastases. The significant improvement in melanoma-specific survival (MSS) from 10 months with systemic therapy to 28 months with liver-directed therapies is a game-changer for patients. The increase in median MSS from 20 to 30 months in more recent years, coinciding with increased CHEMOSAT usage, suggests ongoing refinement and optimization of these techniques. This data strongly supports the adoption of liver-directed therapies as a first-line treatment for this patient population, potentially reshaping treatment protocols and improving outcomes for a historically challenging cancer type.

Oncology Doctor

The results of this study are highly encouraging for uveal melanoma patients with liver metastases. The 180% increase in median MSS for patients receiving liver-directed therapies compared to systemic treatments is substantial. It's particularly noteworthy that the survival benefit has improved over time, likely due to increased use of advanced techniques like CHEMOSAT. This underscores the importance of targeted, organ-specific approaches in managing metastatic disease. However, it's important to note that this was a retrospective study and while the results are promising, they should be confirmed through prospective, randomized trials. Nonetheless, these findings provide a strong rationale for prioritizing liver-directed therapies in the treatment algorithm for these patients.

Financial Analyst

This study's results are potentially transformative for Delcath Systems (NASDAQ: DCTH). The demonstrated efficacy of liver-directed therapies, particularly CHEMOSAT, in improving survival rates could drive increased adoption and market penetration. With CHEMOSAT use rising from 8 out of 33 patients (2005-2015) to 30 out of 56 patients (2016-2021), there's clear momentum in its uptake. This could translate to significant revenue growth for Delcath. Moreover, the study's findings may influence treatment guidelines, potentially positioning CHEMOSAT as a first-line therapy. This could expand Delcath's addressable market and strengthen its competitive position. Investors should monitor for potential regulatory implications and any changes in reimbursement policies that could further boost Delcath's market opportunity.

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, 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:

• 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).

• 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 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/20240828085931/en/

Investor Relations Contact:

ICR Westwicke

investorrelations@delcath.com

Source: Delcath Systems, Inc.

FAQ

What were the key findings of the Delcath Systems (DCTH) study on liver-directed therapy for uveal melanoma?

The study showed that first-line liver-directed therapies, including Delcath's CHEMOSAT system, significantly improved melanoma-specific survival (MSS) in patients with liver metastases from uveal melanoma. Patients receiving first-line liver-directed therapy had a median MSS of 28 months, compared to 10 months for those receiving systemic therapy.

How did the survival rates for DCTH's liver-directed therapy change over time?

The study found that patients diagnosed between 2016-2021 and treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months, compared to 20 months for those diagnosed between 2005-2015. This indicates an improvement in survival rates over time with liver-directed therapies.

What is the CHEMOSAT Hepatic Delivery System developed by Delcath Systems (DCTH)?

CHEMOSAT is a liver-directed therapy developed by Delcath Systems for the treatment of primary and metastatic cancers of the liver. The study showed that CHEMOSAT, along with other liver-directed therapies, significantly improved melanoma-specific survival in patients with liver metastases from uveal melanoma.