Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), a leader in interventional oncology specializing in the treatment of primary and metastatic liver cancers, has announced the publication of an independent study in the European Society for Medical Oncology’s journal of Gastrointestinal Oncology. The research, conducted by investigators at the University Hospital of Leipzig, Germany, is titled “Hepatic chemosaturation with melphalan in patients with primary or secondary liver tumors with or without extrahepatic tumor manifestation.” The study emphasizes the efficacy and safety of repeated chemosaturation treatments using Delcath’s CHEMOSAT® Hepatic Delivery System.
Key Findings from the Independent Study:
Patient Population: This retrospective study assessed the effectiveness of the CHEMOSAT® Hepatic Delivery System in 33 patients with unresectable intrahepatic metastases from various cancers. The cohort included individuals with 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). Seven patients also had limited extrahepatic disease, which did not significantly affect overall survival.
Disease Control Rate: The study demonstrated a disease control rate (DCR) of 91%, with 30 out of 33 patients showing either an objective tumor response or stable disease. Notably, six patients (18.2%) achieved a complete response (CR) in the liver, including five with uveal melanoma and one with cholangiocarcinoma, who received a median of five treatment cycles.
Hepatic Progression-Free Survival: The median hepatic progression-free survival (hPFS) was 52 weeks across all patients. Specific results included:
- 69 weeks (16 months) median hPFS for patients with uveal melanoma.
- 38 weeks (8.5 months) median hPFS for patients with cholangiocarcinoma.
Importance of Repeated Treatments: The study’s use of CHEMOSAT in regularly repeated treatment cycles, akin to systemic chemotherapy, led to long-term disease control in most patients and was well tolerated.
Tolerability and Safety: The safety profile of CHEMOSAT aligned with existing literature. Most patients experienced transient hematological adverse events, managed with supportive care. No significant liver damage was observed, even in those undergoing multiple treatment cycles. Treatment was discontinued in two patients due to adverse events, and two patients withdrew consent during the treatment period.
Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented, “This independent study reinforces the potential of our CHEMOSAT Hepatic Delivery System as a vital tool in managing primary and secondary liver tumors, especially for patients with limited treatment options. The high disease control rate, even in those with extrahepatic tumor spread, highlights the need for further exploration and refinement of this treatment in larger, prospective trials.
