Retrospective Comparison of Two Liver Directed
Therapies in Patients with Metastatic Uveal Melanoma
Significantly Longer Overall Survival for
Patients Treated with Chemosat vs. SIRT (17 and 9.9 months,
respectively; p=0.006)
NEW
YORK, Oct. 16, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, today announced the publication of an article
entitled "Selective Internal Radiotherapy (SIRT) and
Chemosaturation Percutaneous Hepatic Perfusion (CS-PHP) for
Metastasized Uveal Melanoma: A Retrospective Comparative Study" in
the peer reviewed oncology journal Cancers. CS-PHP utilizes
CHEMOSAT, Delcath's proprietary European CE Marked Hepatic Delivery
System (HDS), to administer high-dose chemotherapy (melphalan) to
the liver, while controlling systemic exposure and associated side
effects during a PHP procedure. Initial findings were previously
presented on September 9, 2023 at the
Cardiovascular and Interventional Radiological Society of
Europe (CIRSE) Annual Meeting held
in Copenhagen, Denmark.
Uveal melanoma usually shows a liver-dominant metastasis spread
and is often treated with liver directed therapies. This
retrospective study compared two cohorts of patients with liver
dominant uveal melanoma treated at the University Hospitals
Tubingen, Germany with multiple
cycles of either CS-PHP (N=28) or SIRT (N=34).
Patients included in the study were treated between December 2013 and February
2020. Allocation to treatment was determined by a
multidisciplinary team.
Presence of extrahepatic disease at baseline favored the SIRT
group (68% and 41%, CS-PHP and SIRT, respectively), as did the
hepatic tumor load (0-25%: 57% and 76%; 26%-50%: 29% and 24%;
>50%: 14% and 0%, for CS-PHP and SIRT, respectively). Tumor
responses were evaluated by consensus reading by two experienced
radiologists.
Disease control rates (DCR) were 30% and 18%, for CS-PHP
and SIRT, respectively. Median overall survival (mOS) was 516 days
for CS-PHP and 300.5 days for SIRT. In a Cox regression model,
there was a significant difference between SIRT and CS-PHP
treatment, HR = 0.46, CI 95% (0.23; 0.93), p = 0.030.
An adjusted Cox regression analysis, including the variables
age, sex, presence of extrahepatic metastasis and hepatic load
at baseline, also showed a significant effect of choice of
treatment, HR = 0.32, CI 95% (0.14; 0.73), p = 0.006.
Median progression-free survival (mPFS) was 408.5 days for
CS-PHP and 127.5 days for SIRT; the adjusted Cox regression
analysis showed a trend favoring CS-PHP (p=0.090).
When initially presented at the 2023 CIRSE Annual Meeting held
in Copenhagen, Denmark, presenting
author Prof. Dr. Med. Gerd
Groezinger, stated "Liver directed treatment, including
transarterial radioembolization and CS-PHP, is a critical treatment
modality for patients with metastatic uveal melanoma, given the
longer overall survival seen in the CS-PHP cohort, we conclude that
for metastatic uveal melanoma patients, CS-PHP might be the
superior liver directed treatment option."
"There is a scarcity of comparative studies between liver
directed therapies. This peer reviewed publication authored by
experienced investigators, supports that the PHP procedure, whether
utilizing melphalan delivered by Delcath's CE marked Chemosat or
the FDA approved HEPZATO KIT, may be the preferred liver directed
treatment option for patients with liver-dominant metastatic uveal
melanoma," said Dr. Vojo Vukovic,
Delcath's Chief Medical Officer. "We remain committed to making
this treatment option available to patients in the US by the end of
this year."
The full article can be viewed by clicking here.
About Chemosat and HEPZATO KIT
CHEMOSAT Hepatic
Delivery System for Melphalan percutaneous hepatic perfusion (PHP)
is designated under the medical device regulation for use in
Europe and the United Kingdom. The Hepatic Delivery System
(HDS) is designed to administer high-dose chemotherapy to the liver
while controlling systemic exposure and associated side effects
during a PHP procedure. The use of the HDS allows a healthcare
provider team to surgically isolate the liver while the hepatic
venous blood is filtered during melphalan infusion and subsequent
washout during a PHP procedure. PHP, which can only be performed
with Delcath's HDS, results in loco-regional delivery of a
relatively high melphalan dose. For more information regarding
CHEMOSAT and its use, please visit Chemosat.com.
HEPZATO KIT (melphalan for Injection/Hepatic Delivery System),
approved for use in the United
States by FDA, is a combination drug/device product which
administers HEPZATO (melphalan) directly to the liver through the
HDS, which permits higher drug exposure in target tissues while
limiting systemic toxicity.
HEPZATO KIT is approved in the United
States as a liver-directed treatment for adult patients with
uveal melanoma with unresectable hepatic metastases affecting less
than 50% of the liver and no extrahepatic disease, or extrahepatic
disease limited to the bone, lymph nodes, subcutaneous tissues, or
lung that is amenable to resection or radiation.
HEPZATO KIT Important Safety Information
Patients
eligible for HEPZATO should NOT have any of the following medical
conditions:
- Active intracranial metastases or brain lesions with a
propensity to bleed
- Liver failure, portal hypertension, or known varices at risk
for bleeding
- Surgery or medical treatment of the liver in the previous 4
weeks
- Active cardiac conditions including unstable or severe angina
or myocardial infarction), worsening or new-onset congestive heart
failure, significant arrhythmias, or severe valvular disease
- History of allergies or known hypersensitivity to melphalan or
a component or material utilized within the HEPZATO KIT including
natural rubber latex, heparin, and severe hypersensitivity to
iodinated contrast not controlled by antihistamines and
steroids
Most common adverse reactions or laboratory abnormalities
occurring with HEPZATO treatment are thrombocytopenia,
fatigue, anemia, nausea, musculoskeletal pain, leukopenia,
abdominal pain, neutropenia, vomiting, increased alanine
aminotransferase, prolonged activated partial thromboplastin time,
increased alkaline phosphatase, increased aspartate
aminotransferase and dyspnea.
Severe peri-procedural complications including hemorrhage,
hepatocellular injury, and thromboembolic events may occur via
hepatic intra-arterial administration of HEPZATO. HEPZATO is
available only through a restricted program under a Risk Evaluation
and Mitigation Strategy called the HEPZATO KIT REMS.
Myelosuppression with resulting severe infection, bleeding, or
symptomatic anemia may occur with HEPZATO. Additional cycles of
HEPZATO therapy will be delayed until blood counts have
improved.
Please see the full Prescribing Information, including BOXED
WARNING for the HEPZATO KIT.
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
products, HEPZATO KIT (melphalan for Injection/Hepatic Delivery
System), approved for use in the United
States by FDA, and CHEMOSAT Hepatic Delivery System for
Melphalan percutaneous hepatic perfusion, designated under the
medical device regulation for use in Europe and the United Kingdom, are designed to administer
high-dose chemotherapy to the liver while controlling systemic
exposure and associated side effects during a PHP procedure.
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 press release contains forward-looking statements, which are
subject to certain risks and uncertainties, that can cause actual
results to differ materially from those described. The words
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"intend," "may," "plan," "potential," "predict," "project,"
"should," "target," "will," "would" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Factors
that may cause such differences include, but are not limited to,
uncertainties relating to: the Company's commercialization plans
and its ability to successfully commercialize the HEPZATO KIT; the
Company's successful management of the HEPZATO KIT supply chain,
including securing adequate supply of critical components necessary
to manufacture and assemble the HEPZATO KIT; successful FDA
inspections of the facilities of the Company and those of its
third-party suppliers/manufacturers; the Company's successful
implementation and management of the HEPZATO KIT Risk Evaluation
and Mitigation Strategy; the potential benefits of the
HEPZATO KIT as a treatment for patients with primary and metastatic
disease in the liver; the Company's ability to obtain reimbursement
for the HEPZATO KIT; and the Company's ability to successfully
enter into any necessary purchase and sale agreements with users of
the HEPZATO KIT. For additional information about these
factors, and others that may impact the Company, please see the
Company's filings with the Securities and Exchange Commission,
including those on Forms 10-K, 10-Q, and 8-K. However, new risk
factors and uncertainties may emerge from time to time, and it is
not possible to predict all risk factors and uncertainties.
Accordingly, 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:
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.