Delcath Systems Announces New Data Presented at ESMO 2024 Demonstrating Efficacy of HEPZATO KIT™ in Metastatic Uveal Melanoma Subgroups

Rhea-AI Summary

Delcath Systems (Nasdaq: DCTH) presented new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ at the ESMO Congress. The trial evaluated the efficacy and safety of HEPZATO KIT™ in patients with metastatic uveal melanoma (mUM). Key findings include:

1. No significant differences in overall survival (OS), objective response rate (ORR), or progression-free survival (PFS) between patients with and without extrahepatic lesions or based on prior therapy.
2. Consistent ORR and PFS regardless of liver tumor burden, but worse OS with more extensive liver involvement.
3. Objective tumor responses observed throughout the entire treatment period.
4. Consistent rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs), indicating no cumulative toxicity.

These results support the favorable benefit-risk profile of HEPZATO KIT™ for mUM patients with treatment options.

Positive

• Consistent efficacy across subgroups, including patients with extrahepatic disease
• Objective tumor responses observed throughout the entire treatment period
• No cumulative toxicity observed, supporting a favorable safety profile
• Potential for continued treatment beyond two cycles in patients with stable disease

Negative

• Worse overall survival outcomes associated with more extensive liver involvement

Insights

Medical Research Analyst

The new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ provides valuable insights into its efficacy across different patient subgroups with metastatic uveal melanoma (mUM). Key findings include:

• No significant differences in overall survival (OS), objective response rate (ORR), or progression-free survival (PFS) between patients with and without extrahepatic lesions
• Consistent ORR and PFS regardless of liver tumor burden, though higher liver involvement correlated with worse OS
• Objective tumor responses observed throughout the treatment period, supporting continued treatment until best response is achieved
• Consistent rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs), indicating no cumulative toxicity

These results suggest that HEPZATO KIT™ may offer a promising treatment option for mUM patients, including those with extrahepatic disease, who typically have alternatives. The data reinforces the therapy's potential to address an unmet medical need in this challenging cancer type.

Oncology Doctor

The subgroup analysis of the FOCUS trial presents encouraging data for HEPZATO KIT™ in treating metastatic uveal melanoma (mUM). The consistent efficacy across various patient subgroups, including those with extrahepatic disease, is particularly noteworthy. This suggests that the liver-directed therapy may have broader applicability than initially anticipated.

The observation of tumor responses throughout the treatment period, up to cycle 6, is clinically significant. It supports a more flexible treatment approach, allowing continuation beyond the standard two cycles in patients showing stable disease. This could potentially maximize the therapeutic benefit for individual patients.

However, the correlation between higher liver tumor burden and worse overall survival warrants careful patient selection and monitoring. The consistent safety profile across treatment cycles is reassuring, indicating that prolonged treatment may be feasible without compromising patient safety. Overall, these findings strengthen the position of HEPZATO KIT™ as a valuable addition to the treatment arsenal for mUM.

Financial Analyst

The subgroup analysis data from the FOCUS Phase 3 trial presents a positive outlook for Delcath Systems (NASDAQ: DCTH) and its HEPZATO KIT™. The consistent efficacy across various patient subgroups expands the potential market for the therapy, which could translate to stronger revenue prospects if approved.

Key financial implications include:

• Broader patient eligibility, including those with extrahepatic disease, potentially increasing the addressable market
• Possibility of extended treatment duration (up to 6 cycles or more) could lead to higher per-patient revenue
• Consistent safety profile may reduce potential liability concerns and associated costs

However, investors should note that the correlation between higher liver tumor burden and worse overall survival might limit the therapy's application in advanced cases. The company's ability to effectively market these nuanced results to oncologists will be important for market penetration and revenue growth. Overall, this data strengthens HEPZATO KIT™'s competitive position in the mUM treatment landscape, potentially enhancing Delcath's market value in the oncology sector.

QUEENSBURY, N.Y.--(BUSINESS WIRE)-- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater from University Hospital Southampton at the European Society for Medical Oncology (ESMO) Congress in Barcelona.

The FOCUS trial was a pivotal Phase 3 study designed to evaluate the efficacy and safety of HEPZATO KIT™ in patients with unresectable hepatic metastases from mUM. The primary endpoint of the study was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS). The trial enrolled 102 patients, of whom 91 received treatment. The full results of the FOCUS trial were published on May 4, 2024, in the Annals of Surgical Oncology.

The subgroup analysis evaluated patients with and without extrahepatic disease, treatment-naive versus previously treated patients, and those with low (1-25%) versus high (26-50%) liver tumor burden. There were no significant differences in OS, ORR, or PFS between patients with and without extrahepatic lesions or based on prior therapy. While ORR and PFS remained consistent regardless of liver tumor burden, more extensive liver involvement was associated with worse OS outcomes.

Objective tumor responses were observed throughout the entire treatment period; the earliest following completion of the first treatment cycle, and the latest following treatment cycle 6. This result supports the strategy to continue treatment until best response is achieved. Rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs) remained consistent, indicating an absence of cumulative toxicity. These findings underscore the favorable benefit-risk profile of HEPZATO KIT™ in this patient population, offering a meaningful option for patients who typically have limited treatment options.

Dr. Wheater commented, "The lack of significant differences in outcomes between patients with and without extrahepatic disease is encouraging, particularly for a liver-directed therapy like Melphalan/HDS. Additionally, the fact that responses were observed through all six treatment cycles supports the strategy of continuing treatment beyond two cycles in patients with stable disease."

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/20240916710391/en/

Investor Relations:

ICR Westwicke

investorrelations@delcath.com

Source: Delcath Systems, Inc.

FAQ

What were the key findings of the HEPZATO KIT™ subgroup analysis presented at ESMO 2024 for DCTH?

The subgroup analysis showed no significant differences in overall survival, objective response rate, or progression-free survival between patients with and without extrahepatic lesions or based on prior therapy. Efficacy was consistent regardless of liver tumor burden, but more extensive liver involvement was associated with worse overall survival. Objective tumor responses were observed throughout the treatment period, and there was no cumulative toxicity.

How did liver tumor burden affect the efficacy of HEPZATO KIT™ in the DCTH FOCUS trial?

The objective response rate and progression-free survival remained consistent regardless of liver tumor burden. However, patients with more extensive liver involvement (26-50% tumor burden) had worse overall survival outcomes compared to those with lower liver tumor burden (1-25%).

What did the DCTH FOCUS trial reveal about the safety profile of HEPZATO KIT™?

The FOCUS trial showed consistent rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs) throughout the treatment period, indicating an absence of cumulative toxicity. This supports a favorable safety profile for HEPZATO KIT™ in patients with metastatic uveal melanoma.

How long should HEPZATO KIT™ treatment continue based on the DCTH FOCUS trial results?

The FOCUS trial results support continuing HEPZATO KIT™ treatment until best response is achieved. Objective tumor responses were observed throughout the entire treatment period, from the first cycle to the sixth cycle, suggesting potential benefits of treatment beyond two cycles in patients with stable disease.