Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology firm specializing in liver cancer treatment, has announced the publication of an independent study by researchers at the University Hospital of Leipzig, Germany. Published in the European Society for Medical Oncology’s 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,” demonstrates the efficacy and safety of repeated chemosaturation treatments using Delcath’s CHEMOSAT® Hepatic Delivery System.
Key Findings from the Independent Study:
Patient Population: The retrospective study assessed the efficacy of CHEMOSAT in 33 patients with unresectable intrahepatic metastases from various cancers, including 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). Of these, 7 patients also had limited extrahepatic disease, which did not significantly affect overall survival.
Disease Control Rate: The study achieved a 91% disease control rate (DCR), with 30 out of 33 patients showing either an objective tumor response or stable disease. Notably, 6 patients (18.2%) attained a complete response (CR) in the liver, including 5 with uveal melanoma and 1 with cholangiocarcinoma, after a median of 5 treatment cycles.
Hepatic Progression-Free Survival: The median hepatic progression-free survival (hPFS) was 52 weeks for all patients, with specific outcomes as follows:
- 69 weeks (16 months) for patients with uveal melanoma.
- 38 weeks (8.5 months) for patients with cholangiocarcinoma.
Importance of Repeated Treatments: The study highlighted the benefits of using CHEMOSAT through regularly repeated treatment cycles, akin to systemic chemotherapy. This approach led to long-term disease control in most patients and was well tolerated.
Tolerability and Safety: CHEMOSAT’s safety profile was consistent with previous studies. Most patients experienced transient hematological adverse events, managed with supportive care. No significant liver damage was reported, even with multiple treatment cycles. Treatment was discontinued in 2 patients due to adverse events, and 2 withdrew consent.
Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented, “The findings from this independent study underscore the potential of our CHEMOSAT Hepatic Delivery System as a crucial tool for managing primary and secondary liver tumors, especially for patients with limited treatment options. The high disease control rate, even with extrahepatic tumor spread, highlights the need for further exploration of this treatment in larger, prospective trials.”
The full publication is available here.
About Delcath Systems, Inc., HEPZATO KIT, and CHEMOSAT:
Delcath Systems, Inc. specializes in interventional oncology for liver cancers. Its products, HEPZATO KIT™ and CHEMOSAT® Hepatic Delivery System, deliver high-dose chemotherapy to the liver while managing systemic exposure and side effects during percutaneous hepatic perfusion (PHP).
In the U.S., HEPZATO KIT is approved by the FDA as a combination drug-device product for treating metastatic uveal melanoma with unresectable hepatic metastases. In Europe, the CHEMOSAT device-only configuration is approved as a Class III medical device for conducting PHP procedures for various liver cancers.
