On February 3, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results from a single-institution retrospective study, conducted by University Hospital Southampton NHS Foundation Trust (UHS) in England on the use of the Delcath CHEMOSAT Hepatic Delivery System for the treatment of patients with liver dominant metastatic uveal melanoma (mUM), were published in the journal Melanoma Research (Press release, Delcath Systems, FEB 3, 2022, View Source [SID1234607690]).
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The study, Chemosaturation with percutaneous hepatic perfusion of melphalan for metastatic uveal melanoma, by Dr. Sachin Modi, et al, evaluated the safety and efficacy of the CHEMOSAT Hepatic Delivery System in 81 patients with liver dominant metastatic uveal melanoma treated with CHEMOSAT between August 2012 and September 2020. Forty-one (50.6%) patients had received other treatments, either systemic or liver-directed, before PHP treatment. The median time to treatment from diagnosis of stage IV disease was 158 days. Tumor response was evaluated following each PHP treatment using Response Evaluation Criteria in Solid Tumors (RECIST), and serious adverse events (SAEs) were evaluated using Common Terminology Criteria for Adverse Events (CTCAE).
250 PHP procedures were performed in 81 patients (median of three per patient). The analysis demonstrated a hepatic disease control rate of 88.9% (72/81), a hepatic response rate of 66.7% (54/81), and an overall response rate of 60.5% (49/81). After a median follow-up of 12.9 months, median overall progression-free survival (PFS) and median overall survival (OS) were 8.4 and 14.9 months, respectively.
Treatment-emergent adverse events of Grade 3 or 4 occurred in 23 patients (27.7%) The most common Grade 3 or 4 hematological toxicities were anemia observed in 11 patients (13.3%) and thrombocytopenia observed in 10 patients (12%). There were no fatal treatment-related adverse events.
Investigators concluded that PHP provides excellent response rates and progression free survival compared with other available treatments, with a decreasing side effect profile with experience. Combination therapy with systemic agents may be viable to further advance overall survival.
"This study adds to the growing body of published research of the efficacy of our CHEMOSAT system in the European commercial setting," said Gerard Michel, CEO of Delcath. "The improved safety profile of the Gen2 device is consistent with our recently released phase 3 FOCUS trial data as well as the progression-free-survival efficacy results."
A PDF of the open access article can be viewed in its entirety, via immediate download link, by clicking here.