Delcath Systems Reports Positive Independent Study on Repeated Hepatic Chemosaturation for Liver Tumors

Delcath Systems, Inc. (Nasdaq: DCTH) recently shared the results of an independent study conducted by the University Hospital of Leipzig, Germany, focusing on the efficacy and safety of repeated chemosaturation treatments using Delcath’s CHEMOSAT® Hepatic Delivery System. The findings, published in the European Society for Medical Oncology journal of Gastrointestinal Oncology, offer key insights into the treatment of primary and metastatic liver cancers.

The study titled “Hepatic chemosaturation with melphalan in patients with primary or secondary liver tumors with or without extrahepatic tumor manifestation” assessed the effectiveness of CHEMOSAT in a cohort of 33 patients with unresectable intrahepatic metastases from various cancers. The patient population included individuals with uveal melanoma (19 patients), cholangiocarcinoma (8 patients), hepatocellular carcinoma (2 patients), and one patient each with ciliary body melanoma, acinar cell carcinoma, pancreatic cancer, or tonsil cancer. Some of these patients also had limited extrahepatic disease, which did not significantly impact their overall survival.

One of the standout results from the study was the reported disease control rate (DCR) of 91%, with 30 out of 33 patients experiencing either an objective tumor response or stable disease. Notably, 18.2% of the patients, which includes 5 with uveal melanoma and 1 with cholangiocarcinoma, achieved complete response in the liver after a median of 5 treatment cycles.

When looking at hepatic progression-free survival (hPFS), the median duration across all patients was 52 weeks. Patients with uveal melanoma had a particularly strong outcome with a median hPFS of 69 weeks (16 months), while those with cholangiocarcinoma had a median hPFS of 38 weeks (8.5 months).

The study emphasized the importance of repeated treatments using CHEMOSAT. The approach of administering regularly repeated treatment cycles proved successful in achieving long-term disease control for most patients and was well tolerated. The safety profile of CHEMOSAT was in line with existing literature, with most patients experiencing transient hematological adverse events that were managed with supportive care. Importantly, no significant liver damage was observed even in patients undergoing multiple treatment cycles, although treatment was discontinued in two patients due to adverse events, and two others withdrew consent during the treatment period.

Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, noted that the findings from this independent study underscore the potential of CHEMOSAT as a vital tool in the management of liver tumors, especially for patients with limited treatment options. The high rate of disease control, even among those with extrahepatic tumor spread, highlights the importance of further exploring this treatment approach in larger, prospective trials.

Delcath Systems, Inc. is dedicated to advancing the treatment of primary and metastatic liver cancers through its proprietary products: HEPZATO KIT™ and CHEMOSAT® Hepatic Delivery System. The HEPZATO KIT, used in the United States, combines the chemotherapeutic drug melphalan with Delcath's Hepatic Delivery System (HDS) to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and side effects. This method is approved for treating adult patients with metastatic uveal melanoma with unresectable hepatic metastases that meet specific criteria.

In Europe, the CHEMOSAT Hepatic Delivery System, regulated as a Class III medical device, has been employed in percutaneous hepatic perfusion procedures at leading medical centers to treat various liver cancers, offering a promising therapeutic option for patients.