On September 26, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that results from a prospective study conducted by Leiden University Medical Center (LUMC) in The Netherlands of the use of the Delcath Hepatic CHEMOSAT Delivery System to treat patients with metastatic ocular melanoma with liver metastases, were presented as a poster at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting this week (Press release, Delcath Systems, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2369022 [SID1234529645]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The study—Percutaneous Hepatic Perfusion in Patients with Unresectable Liver Metastases from Ocular Melanoma using Delcath Systems’ Second Generation (GEN 2) Hemofiltration System: A Prospective Phase 2 Study—was conducted by researchers at LUMC reported by T.S. Meijer, MD. The study prospectively evaluated tumor response rate, safety, overall survival (OS), overall progression-free survival (PFS) and hepatic progression-free survival (hPFS) in 35 patients with ocular melanoma liver metastases treated at LUMC from February 2014 to June 2017. In accordance with the study’s protocol, patients were treated with a maximum of two cycles of PHP Therapy and a total 67 PHP treatments were administered to the 35 patients in the study.
Post-treatment assessments were possible in 32 patients. Results of the study, according to RECIST 1.1, showed that a complete response was observed in one patient (3.1%) and a partial response was observed in 21 patients (65.6%), resulting in an objective response rate of 68.7%. Stable disease was observed in four patients (12.5%), for a total disease control rate of 81.2%. Median OS was 15.6 months, median PFS was 8.6 months, and median hPFS was 10.8 months.
In their safety analysis, the researchers reported a total of 14 serious adverse events, including one case of cardiac ischemia, five cases of prolonged hospital admission to treat peri-procedure complications, and eight patients re-hospitalized for a variety of post-procedure symptoms. No deaths occurred on the study. No severe bleeding complications, myocardial or cerebral infarctions were observed. Hematologic toxicities of Grade 3/4 were observed in most patients, with 18 (54.5%) patients experiencing thrombocytopenia and 22 patients (66.7%) experiencing neutropenia. The researchers stated that hematologic events were manageable or self-limiting. Additionally, no grade 3 or 4 hepatic serious adverse events were observed by the researchers. The LUMC investigators concluded that, in their institution’s study, PHP Therapy was shown to have a manageable adverse event profile and to be a potentially valuable treatment for certain patients with ocular melanoma liver metastases.
Commenting on the study, Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Delcath Systems, said, "The results from the LUMC study are very encouraging since they are from a prospective trial with endpoints very similar to those in our amended Registration Trial in this same patient population. The LUMC team intends to submit a more extensive analysis of their data for publication, and we look forward to the publication of those more detailed results."
The CIRSE 2018 annual meeting was held in Lisbon, Portugal September 22-25, 2018.