Delcath Systems, Inc. Announces Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients

Rhea-AI Summary

Delcath Systems, Inc. (Nasdaq: DCTH) announced positive outcomes from an independent study on hepatic perfusion for uveal melanoma patients. The study, conducted by researchers at Moffitt Cancer Center, compared Delcath's HEPZATO KIT™ to immunotherapy and other liver-directed therapies. Key findings include:

1. Overall Survival (OS): Median OS of 22.4 months for first-line therapy and 18.4 months for second-line therapy with HEPZATO KIT.

2. Hepatic Progression-Free Survival (hPFS): First-line HEPZATO KIT showed 17.6 months median hPFS, outperforming immunotherapy (8.8 months) and other therapies (9.2 months).

3. Progression-Free Survival (PFS): First-line HEPZATO KIT demonstrated 15.4 months median PFS, surpassing immunotherapy and other therapies.

The study suggests HEPZATO KIT provides better disease control and improved progression-free survival for patients with hepatic metastases from uveal melanoma.

Positive

• HEPZATO KIT showed superior median Overall Survival of 22.4 months as first-line therapy
• First-line HEPZATO KIT demonstrated longer median Hepatic Progression-Free Survival (17.6 months) compared to immunotherapy (8.8 months) and other liver-directed therapies (9.2 months)
• HEPZATO KIT as second-line therapy resulted in median Hepatic Progression-Free Survival that was not reached, outperforming other treatments
• First-line HEPZATO KIT showed longer median Progression-Free Survival (15.4 months) compared to immunotherapy (8.8 months) and other liver-directed therapies (9.2 months)

Negative

• None.

Insights

Medical Research Analyst

This independent study provides compelling evidence for the efficacy of Delcath's HEPZATO KIT™ in treating hepatic metastases from uveal melanoma. The improved hepatic progression-free survival (hPFS) of 17.6 months as first-line therapy and not reached as second-line therapy is particularly noteworthy. These results significantly outperform both immunotherapy and other liver-directed therapies, suggesting a potential paradigm shift in treatment protocols. The overall survival (OS) of 22.4 months for first-line therapy is also promising, considering the typically poor prognosis for metastatic uveal melanoma. However, it's important to note the small sample size (N=30), which may limit the generalizability of these findings. Future larger-scale studies will be important to confirm these results and establish HEPZATO KIT™ as a standard of care.

Oncology Doctor

The results of this study are indeed encouraging for patients with liver metastases from uveal melanoma. The hepatic progression-free survival (hPFS) data is particularly impressive, showing a clear advantage of HEPZATO KIT™ over current standard treatments. This is important because liver metastases are often the life-limiting factor in uveal melanoma. The overall progression-free survival (PFS) of 15.4 months as first-line therapy and 22.2 months as second-line therapy also indicates significant disease control. However, we must interpret these results cautiously due to the retrospective nature of the study and the small patient cohort. The potential combination of HEPZATO KIT™ with systemic therapies, as suggested by Dr. Zager, could be an exciting avenue for future research, potentially leading to even better outcomes for these challenging cases.

Financial Analyst

This study's positive outcomes could significantly impact Delcath Systems' market position. The superior efficacy of HEPZATO KIT™ compared to existing treatments may drive increased adoption, potentially boosting Delcath's revenue streams. However, investors should note that the product is not yet FDA-approved, which is a important hurdle. The $1.13 billion uveal melanoma market presents a substantial opportunity, but Delcath will need to navigate regulatory approvals and compete with established treatments. The company's Nasdaq: DCTH stock may see increased interest following this news, but caution is warranted due to the early stage of these findings. Future milestones to watch include larger clinical trials, potential FDA submissions and any partnerships or licensing deals that could accelerate commercialization. Delcath's financial health and ability to fund further development will be critical factors in capitalizing on these promising results.

NEW YORK--(BUSINESS WIRE)-- Delcath Systems, Inc. (Nasdaq: DCTH) (the “Company” or “Delcath”), an interventional oncology company specializing in the treatment of primary and metastatic liver cancers, today announced the publication of a retrospective study by independent investigators in the Annals of Surgical Oncology. The study, titled “Hepatic and Overall Progression-Free Survival After Percutaneous Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for Metastatic Uveal Melanoma,” was conducted by researchers at Moffitt Cancer Center in Tampa, Florida. The 30-patient study reported that Delcath’s HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improved progression-free survival in patients with hepatic metastases from uveal melanoma, compared to both immunotherapy and other liver-directed therapies.

Key Findings from the Study:

• Overall Survival (OS): The study reported median OS of 22.4 months for patients treated with HEPZATO KIT as a first-line therapy (N=17) and 18.4 months as a second-line therapy (N=6).
• Hepatic Progression-Free Survival (hPFS): Patients receiving HEPZATO KIT as first-line therapy had a median hPFS of 17.6 months (N=17), compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. When used as a second-line therapy, HEPZATO KIT resulted in a median hPFS that was not reached (N=6), showing better outcomes than immunotherapy (14.7 months, N=5) and other liver-directed therapies (7.5 months, N=3) in this patient cohort.
• Progression-Free Survival (PFS): The median overall PFS was 15.4 months (N=17) for patients receiving HEPZATO KIT as first-line therapy, compared to 8.8 months (N=6) for immunotherapy and 9.2 months (N=7) for other liver-directed therapies. In the second-line setting, HEPZATO KIT resulted in a median PFS of 22.2 months (N=6), compared to 14.7 months (N=5) for immunotherapy and 7.5 months (N=3) for other liver-directed therapies, reflecting longer disease control in this group.

Jonathan Zager, MD Chief Academic Officer and Director of Regional Therapies at Moffitt Cancer Center, remarked, “The findings from this study reaffirm the critical role of melphalan/HDS in managing liver-dominant metastatic uveal melanoma. These results highlight the potential benefits melphalan/HDS offers to patients, particularly in the context of first- and second-line treatments. My team is committed to further exploring the potential of combining melphalan/HDS with systemic therapies to continue improving patient outcomes.”

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/20240827426026/en/

Investor Relations:

ICR Westwicke

investorrelations@delcath.com

Source: Delcath Systems, Inc.

FAQ

What were the key findings of the HEPZATO KIT study for uveal melanoma patients with liver metastases?

The study found that HEPZATO KIT provided better disease control and improved progression-free survival compared to immunotherapy and other liver-directed therapies. Key findings include a median Overall Survival of 22.4 months for first-line therapy, a median Hepatic Progression-Free Survival of 17.6 months for first-line therapy, and a median Progression-Free Survival of 15.4 months for first-line therapy.

How did HEPZATO KIT perform as a second-line therapy for uveal melanoma liver metastases?

As a second-line therapy, HEPZATO KIT showed promising results. The median Overall Survival was 18.4 months, the median Hepatic Progression-Free Survival was not reached (outperforming other treatments), and the median Progression-Free Survival was 22.2 months, which was longer than immunotherapy and other liver-directed therapies.

Who conducted the study on HEPZATO KIT for uveal melanoma liver metastases?

The study was conducted by independent researchers at Moffitt Cancer Center in Tampa, Florida. It was a retrospective study involving 30 patients and was published in the Annals of Surgical Oncology.

What is the stock symbol for Delcath Systems, Inc.?

The stock symbol for Delcath Systems, Inc. is DCTH. It is listed on the Nasdaq stock exchange.