Delcath Systems, Inc. Announces Promising Results from Independent Study on Repeated Hepatic Chemosaturation for Liver Tumors

Rhea-AI Summary

Delcath Systems (Nasdaq: DCTH) announced promising results from an independent study on its CHEMOSAT® Hepatic Delivery System for liver tumors. The study, conducted at the University Hospital of Leipzig, Germany, evaluated 33 patients with various cancers, including uveal melanoma and cholangiocarcinoma. Key findings include:

- A 91% disease control rate
- 18.2% of patients achieved complete response in the liver
- Median hepatic progression-free survival of 52 weeks across all patients
- 69 weeks median hPFS in uveal melanoma patients
- 38 weeks median hPFS in cholangiocarcinoma patients

The study highlights the efficacy and safety of repeated CHEMOSAT treatments, showing potential as an essential tool for managing primary and secondary liver tumors.

Positive

• 91% disease control rate achieved across various cancer types
• 18.2% of patients (6 out of 33) achieved complete response in the liver
• Median hepatic progression-free survival of 52 weeks across all patients
• 69 weeks median hepatic progression-free survival in uveal melanoma patients
• 38 weeks median hepatic progression-free survival in cholangiocarcinoma patients
• Treatment well-tolerated with manageable adverse events

Negative

• Treatment discontinued in 2 patients due to adverse events
• 2 patients withdrew consent during the treatment period

Insights

Medical Research Analyst

The independent study on CHEMOSAT presents promising results for liver tumor treatment. The 91% disease control rate and 18.2% complete response rate are particularly noteworthy. The median hepatic progression-free survival of 52 weeks across all patients is impressive, especially for uveal melanoma (69 weeks) and cholangiocarcinoma (38 weeks).

The study's approach of using repeated treatment cycles appears to be a key factor in achieving long-term disease control. This strategy, similar to systemic chemotherapy, could potentially change the treatment paradigm for liver tumors. The safety profile seems manageable, with mostly transient hematological adverse events and no significant liver damage reported, even after multiple cycles.

However, it's important to note the study's limitations: it's retrospective and has a relatively small sample size (33 patients). Larger, prospective trials will be important to confirm these findings and establish CHEMOSAT's role in liver cancer treatment.

Financial Analyst

This study could significantly impact Delcath's market position. The positive results across multiple cancer types, especially in uveal melanoma and cholangiocarcinoma, expand the potential patient population for CHEMOSAT. This could translate into increased adoption and revenue growth.

The high disease control rate (91%) and impressive progression-free survival data strengthen CHEMOSAT's value proposition, potentially leading to broader insurance coverage and reimbursement. The safety profile, consistent with published literature, reduces regulatory risks.

However, investors should note that this is an independent study, not a company-sponsored trial. While it adds credibility, it may not directly influence regulatory decisions. The small sample size (33 patients) and retrospective nature of the study indicate that larger, prospective trials are still needed to fully validate these results.

Overall, this news is positive for Delcath, potentially accelerating market adoption and strengthening its competitive position in the interventional oncology space.

NEW YORK--(BUSINESS WIRE)-- Delcath Systems, Inc. (Nasdaq: DCTH) (“Company” or “Delcath”), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of an independent study conducted by investigators at the University Hospital of Leipzig, Germany, in the European Society for Medical Oncology journal of Gastrointestinal Oncology. The study, titled “Hepatic chemosaturation with melphalan in patients with primary or secondary liver tumors with or without extrahepatic tumor manifestation,” highlights the efficacy and safety of repeated chemosaturation treatments using Delcath’s CHEMOSAT^® Hepatic Delivery System.

Figure 1: Individual changes in tumor sizes during CHEMOSAT treatment. (A) Individual changes in tumor sizes during CHEMOSAT treatment. On the y-axis the change in tumor size is indicated according to the baseline lesions. (B) Waterfall plot of changes in the size of target lesions at the end of observation. Dashed lines are thresholds for hepatic PD, hepatic SD, hepatic PR and hepatic CR. CR, complete response; HCC, hepatocellular carcinoma; ICC, intrahepatic cholangiocellular carcinoma; other, ciliary body melanoma, angiosarcoma, tonsil and pancreatic carcinoma; PD, progressive disease; PR, partial response; SD, stable disease; UM, uveal melanoma. (Graphic: Business Wire)

Key Findings from the Independent Study:

• Patient Population: This retrospective study evaluated the efficacy of CHEMOSAT in 33 previously treated patients with unresectable intrahepatic metastases from various cancers: uveal melanoma (N=19), cholangiocarcinoma (N=8), hepatocellular carcinoma (N=2), and one patient each with ciliary body melanoma, acinar cell carcinoma, pancreatic cancer, or tonsil cancer (N=4). In addition to hepatic metastases, 7 out of 33 patients also had limited extrahepatic disease, which was found not to significantly impact overall survival.
• Disease Control Rate: The study reported a disease control rate (DCR) of 91%, with 30 out of 33 patients experiencing either objective tumor response or stable disease. Notably, 6 patients (18.2%) achieved complete response (CR) in the liver, including 5 patients with uveal melanoma and 1 patient with cholangiocarcinoma, who received a median of 5 treatment cycles.
• Hepatic Progression-Free Survival: Median hepatic progression-free survival (hPFS) was 52 weeks across all patients, with particularly strong outcomes for specific cancers:
  • 69 weeks (16 months) median hPFS in patients with uveal melanoma.
  • 38 weeks (8.5 months) median hPFS in patients with cholangiocarcinoma.
• Importance of Repeated Treatments: The investigators’ approach of using CHEMOSAT in the form of regularly repeated treatment cycles as clinically indicated (Figure 1), similar to systemic chemotherapy, resulted in long-term disease control in the majority of patients and was well tolerated.
• Tolerability and Safety: The safety profile of CHEMOSAT was consistent with published literature. Most patients experienced transient hematological adverse events, which were routinely managed with supportive care. Importantly, no significant liver damage was reported, even in patients who underwent multiple treatment cycles. Treatment was discontinued in 2 patients due to adverse events, and 2 patients withdrew consent during the treatment period.

Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented, “The results of this independent study reinforce the potential of our CHEMOSAT Hepatic Delivery System as an essential tool in the management of primary and secondary liver tumors, particularly for patients with limited treatment options. The high rate of disease control observed, even in patients with extrahepatic tumor spread, underscores the importance of continuing to explore and refine this treatment approach in larger, prospective trials.”

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/20240826877468/en/

Investor Relations:

ICR Westwicke

investorrelations@delcath.com

Source: Delcath Systems, Inc.

FAQ

What is the disease control rate reported in the CHEMOSAT study for Delcath Systems (DCTH)?

The independent study reported a disease control rate (DCR) of 91% for Delcath Systems' (DCTH) CHEMOSAT Hepatic Delivery System, with 30 out of 33 patients experiencing either objective tumor response or stable disease.

What was the median hepatic progression-free survival for uveal melanoma patients treated with CHEMOSAT (DCTH)?

The study reported a median hepatic progression-free survival (hPFS) of 69 weeks (16 months) for patients with uveal melanoma treated with Delcath Systems' (DCTH) CHEMOSAT Hepatic Delivery System.

How many patients achieved complete response in the liver using Delcath's CHEMOSAT system (DCTH)?

According to the study, 6 patients (18.2%) achieved complete response (CR) in the liver using Delcath Systems' (DCTH) CHEMOSAT Hepatic Delivery System, including 5 patients with uveal melanoma and 1 patient with cholangiocarcinoma.

What was the safety profile of CHEMOSAT (DCTH) in the independent study?

The safety profile of CHEMOSAT (DCTH) was consistent with published literature. Most patients experienced transient hematological adverse events, which were routinely managed with supportive care. No significant liver damage was reported, even in patients who underwent multiple treatment cycles.