Independent Investigator Study Compared Two
Liver Directed Therapies in Patients with Metastatic Uveal
Melanoma
Significantly Longer Overall Survival for
Patients Treated with Chemosat vs. SIRT (516 and 301 days,
respectively; p=0.006)
NEW
YORK, Sept. 11, 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 details of an oral presentation
by independent investigators 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. The
retrospective study presented at CIRSE compared two cohorts of
patients with liver dominant uveal melanoma treated at the
University Hospital Tubingen, Germany with multiple cycles of either
transarterial radioembolization (SIRT, N=34) or
chemosaturation-percutaneous hepatic perfusion (Chemosat or CS-PHP,
N=28). Objective tumor response (ORR) rates were 5% and 9%, for
SIRT and CS-PHP, respectively. Median overall survival (mOS) was
301 days for SIRT and 516 days for CS-PHP, the adjusted Cox
regression analysis showed a significant difference (p=0.006).
Median progression-free survival (mPFS) was 127.5 days for SIRT and
408.5 days for CS-PHP; the adjusted Cox regression analysis showed
a trend favoring CS-PHP without reaching statistical significance
(p=0.090).
"Liver directed treatment, including transarterial
radioembolization and CS-PHP, is a critical treatment modality for
patients with metastatic uveal melanoma," stated presenting author
Prof. Dr. Med. Gerd Groezinger, from
the University of Tubingen. "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."
"The presentation of these results adds to the growing body of
evidence that the PHP procedure, whether utilizing melphalan
delivered by Delcath's CE marked Chemosat or the FDA approved
HEPZATO KIT, is an important treatment option for patients with
liver-dominant uveal melanoma," said Dr. Vojo Vukovic, Delcath's Chief Medical Officer.
"We look forward to making this treatment option available to
patients in the US later this year."
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 Percutaneous Hepatic
Perfusion (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
metastatic uveal melanoma (mUM) 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 (PHP), 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.