Results of Single Center Study on Delcath’s CHEMOSAT® Hepatic Delivery System Published in Melanoma Research
February 03 2022 - 4:30PM
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, announces 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.
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.
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company’s proprietary percutaneous hepatic perfusion (PHP)
system is designed to administer high-dose chemotherapy to the
liver while controlling systemic exposure and associated side
effects. In the United States, the PHP system is being developed
under the tradename HEPZATO KIT (melphalan hydrochloride for
injection/hepatic delivery system), or HEPZATO, for the treatment
of metastatic ocular melanoma (mOM), also known as metastatic uveal
melanoma (mUM) and is considered a combination drug and device
product regulated by the United States Food and Drug Administration
(FDA).
In Europe, the PHP system is regulated as a Class IIb medical
device and is approved for sale under the trade name CHEMOSAT
Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has
been used at major medical centers to treat a wide range of cancers
of the liver.
Safe Harbor / Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a
safe harbor for forward-looking statements made by the Company or
on its behalf. This news release contains forward-looking
statements, which are subject to certain risks and uncertainties
that can cause actual results to differ materially from those
described. Factors that may cause such differences include, but are
not limited to, uncertainties relating to: the timing and results
of the Company’s clinical trials, including without limitation
the receipt of additional data and the performance of additional
analyses with respect to the mOM clinical trial, the impact of the
COVID-19 pandemic on the timely monitoring of patients in the
global Phase 3 mOM clinical trial and resubmission of the NDA; the
impact of the presentations at major medical conferences and future
clinical results consistent with the data presented; approval of
Individual Funding Requests for reimbursement of the CHEMOSAT
procedure; the impact, if any, of ZE reimbursement on potential
CHEMOSAT product use and sales in Germany; clinical adoption,
use and resulting sales, if any, for the CHEMOSAT system to deliver
and filter melphalan in Europe including the key markets
of Germany and the UK; the Company’s ability to
successfully commercialize the HEPZATO KIT/CHEMOSAT system and the
potential of the HEPZATO KIT/CHEMOSAT system as a treatment for
patients with primary and metastatic disease in the liver; our
ability to obtain reimbursement for the CHEMOSAT system in various
markets; approval of the current or future HEPZATO KIT/CHEMOSAT
system for delivery and filtration of melphalan or other
chemotherapeutic agents for various indications in
the U.S. and/or in foreign markets; actions by the FDA or
foreign regulatory agencies; the Company’s ability to successfully
enter into strategic partnership and distribution arrangements in
foreign markets and the timing and revenue, if any, of the same;
uncertainties relating to the timing and results of research and
development projects; and uncertainties regarding the Company’s
ability to obtain financial and other resources for any research,
development, clinical trials and commercialization activities.
These factors, and others, are discussed from time to time in our
filings with the Securities and Exchange Commission. You
should not place undue reliance on these forward-looking
statements, which speak only as of the date they are made. We
undertake no obligation to publicly update or revise these
forward-looking statements to reflect events or circumstances after
the date they are made.
Contact:
Delcath Investor Relations
Email: investorrelations@delcath.com
Hayden IR
James
Carbonara(646)-755-7412james@haydenir.com
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