US-based Delcath Systems has shared positive data from an independent study showing that its Hepzato Kit (melphalan/hepatic delivery system) offers superior liver disease control and progression-free survival (PFS) in patients with metastatic uveal melanoma with liver metastases.
The kit combines the chemotherapy drug melphalan with Delcath’s propriety hepatic delivery system (HDS), which isolates and filters hepatic venous blood from the systemic circulation during melphalan infusion.
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This chemosaturation drug-device combo system delivers a targeted high dose of chemotherapy to the liver while minimising systemic exposure.
Data from the study, published in the Annals of Surgical Oncology, showed that patients treated with Hepzato indicated a median overall survival (OS) of 22.4 months for first-line therapy and 18.4 months for second-line therapy. Hepatic progression-free survival (hPFS) for first-line therapy patients was 17.6 months, compared to the 8.8 months for immunotherapy and 9.2 months for other liver-directed therapies.
In second-line therapy, the median hPFS was not reached, demonstrating better outcomes than the other treatment options. Overall PFS was also favourable, with a median of 15.4 months for first-line therapy and 22.2 months for second-line therapy, outperforming alternatives.
Delcath’s Hepzato Kit secured US Food and Drug Administration (FDA) approval in August 2023 for treating the extra-ocular metastases of uveal melanoma, which affect either up to 50% of the liver tissue without extrahepatic disease, or metastases limited to extrahepatic organs namely bone, lymph nodes, subcutaneous tissue, or lung.
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By GlobalDataThe US approval triggered $34.9m worth of funding, from Delcath’s private investment in public equity (PIPE) financing tranche. In Europe, the device component, dubbed Chemosat, is regulated as a Class III medical device for treating a range of liver cancers.
Jonathan Zager, chief academic officer and director of regional therapies at Moffitt Cancer Center in Tampa, Florida, said: “The findings from this study reaffirm the critical role of melphalan/HDS in managing liver-dominant metastatic uveal melanoma. These results highlight the potential benefits melphalan/HDS offers to patients, particularly in the context of first-line and second-line treatments.”
The company recently announced an increase in Q2 2024 revenue, totalling $7.8m, driven by the success of Hepzato and Chemosat.
