HEPZATO KIT is the only FDA approved liver-directed therapy
to treat metastatic uveal melanoma
Approval includes treatment naïve and previously treated
patients and is not limited by HLA genotype
Delcath to hold Business Update Call on August 15, 2023 at 8:00
a.m. Eastern Time
NEW
YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, announced that today the US Food and Drug
Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic
Delivery System) 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.
mUM is a rare and aggressive form of metastatic cancer with a US
incidence of approximately 1,000 cases per year. Ninety
percent of mUM involves the liver, and liver failure is often the
cause of death. National Comprehensive Cancer Network (NCCN)
guidelines recommend liver-directed therapies for mUM patients with
liver metastases. HEPZATO KIT is the only liver-directed therapy
approved by the FDA for the treatment of mUM and percutaneous
hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is
already included in the NCCN guidelines.
"FDA approval of HEPZATO KIT marks the beginning of a new
chapter for Delcath and the culmination of the Company's commitment
to bring this treatment option to patients suffering from
metastatic uveal melanoma," said Gerard
Michel, Delcath's Chief Executive Officer. "We look
forward to partnering with cancer centers across the country to
build a network of treatment sites trained in the use of this novel
therapy."
The Company plans to have commercial product available in the
fourth quarter, and patients will continue to be enrolled and
treated at Expanded Access Program (EAP) sites.
The approval of HEPZATO KIT was based primarily on the results
of the FOCUS Study (NCT02678572), a Phase 3, single arm,
multicenter, open label study, which administered HEPZATO
(melphalan) via the hepatic delivery system (HDS) during a PHP
procedure. Ninety-one (91) patients received treatment every 6 to 8
weeks, for up to 6 treatments. The main efficacy endpoints
were objective response rate (ORR) and duration of response (DoR)
as assessed by an independent review committee using RECIST v1.1.
ORR was 36.3% (95% CI: 26.4, 47.0) and median DoR was 14 months
(95% CI: 8.3, 17.7). The Disease Control Rate (DCR) observed in
treated patients was 73.6% (95% CI: 63.3, 82.3) with 7 complete
responses (7.7%), and 26 (28.6%) partial responses.
The patient population enrolled in the FOCUS Study included
patients with hepatic and extra-hepatic lesions subject to a
treatment plan, as well as both treatment naïve (56.0%) and
previously treated (44.0%) patients, irrespective of HLA
genotype.
The HEPZATO KIT prescribing information has a boxed warning,
which includes three sections: toxicity related to the procedure,
myelosuppression and a Risk Evaluation and Mitigation Strategy
program, commonly known as REMS, to manage and mitigate these
risks. Serious adverse events associated with the PHP procedure
with the HEPZATO KIT, such as hemorrhage, hepatocellular injury,
and thromboembolic events, occurred in less than 5% of treated
patients. Myelosuppressive adverse events including
thrombocytopenia, anemia, and neutropenia, are well-known and
predictable side effects of melphalan and are routinely managed
with standard supportive care measures.
The HEPZATO KIT REMS is designed to ensure consistent conduct of
the PHP procedure and that only treatment teams who have received
appropriate training perform the PHP procedure.
"HEPZATO KIT is the only liver-directed therapy that can treat
the whole liver," said Vojislav
Vukovic, Delcath's Chief Medical Officer. "Scientific
literature supports that HEPZATO KIT may have broad applicability
in other tumor types, and we intend to expand our development
efforts beyond uveal melanoma given the high incidence of
unresectable hepatic dominant tumors."
The approval effectively triggers the second tranche of
financing tied to the previously announced March 29, 2023 Private Investment in Public
Equity (PIPE) financing. Participants in the PIPE have 21 days to
exercise their Tranche A warrants, translating to up to
approximately $34.9 million of
additional funding to Delcath. In addition, upon the Company's
announcement of recording at least $10.0
million in quarterly U.S. revenue from the commercialization
of HEPZATO KIT, participants in the PIPE will have 21 days to
exercise their Tranche B warrants, resulting in up to an additional
$24.9 million in funding to
Delcath.
About HEPZATO KIT
HEPZATO KIT is a combination product that administers HEPZATO
(melphalan), a well-known and long-approved chemotherapeutic agent,
directly to the liver through Delcath's novel device delivery
system, the Hepatic Delivery System (HDS), which permits higher
drug exposure in target tissues while limiting systemic toxicity.
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.
About Hepatic-Dominant Metastatic Uveal Melanoma
Uveal melanoma is a very rare form of cancer that affects
melanocytes in the eye with approximately 5% of all melanomas being
uveal. The US incidence of primary uveal melanoma is approximately
2,000 cases per year. While surgical or radiation therapy of
the primary tumor is generally successful, approximately half of
all patients with uveal melanoma will develop metastatic disease,
primarily due to this inability to treat early micro-metastases of
the primary tumor. The metastases occur predominantly in the liver
(~90% of patients), and less commonly in the lungs and bones.
Prior to the approval of HEPZATO KIT, there was no approved
liver-directed therapy for patients with metastatic uveal melanoma.
There is one systemic therapy, KIMMTRAK®
(tebentafusp-tebn), approved for a subset of mUM patients with
HLA-A*02:01-positive unresectable or metastatic uveal melanoma.
Because most patients, regardless of HLA-A*02:01 status, eventually
progress, there is a need for both first line treatment of
HLA-A*02:01- negative patients and second line treatment for
HLA-A*02:01-positive patients.
The treatment of liver metastases is critical since liver
failure is most often the cause of death for patients with
metastatic uveal melanoma. Because of this, National Comprehensive
Cancer Network guidelines recommends liver-directed therapies for
patients with metastases to the liver, including embolization
(i.e., transarterial chemoembolization, radioembolization or
immunoembolization), ablative procedures (i.e., thermal ablation,
cryotherapy) as well as PHP which can only be performed with the
HEPZATO KIT. It is noteworthy that PHP was already on guidelines
prior to FDA approval.
Metastatic uveal melanoma tumors in the liver tend to have a
miliary pattern of spread where there are numerous radiographically
evident and microscopically occult metastases in the liver.
Therefore, an effective treatment should ideally treat the entire
liver and allow for retreatment. None of the embolization or
ablation treatments fulfill these requirements nor have any of
these techniques been studied in prospective multi-center trials.
The PHP procedure utilizing the HEPZATO KIT saturates the entire
liver, regardless of the location or imageability of the lesions
and most patients are able to undergo multiple treatments.
Please see the full Prescribing Information, including BOXED
WARNING for the HEPZATO KIT.
Delcath will hold a business update conference call August 15, 2023, at 8:00
AM Eastern Time to discuss the FDA approval.
Conference Call Information
To participate in this event, dial-in approximately 5 to 10
minutes before the beginning of the call.
Event Date: Tuesday, August 15,
2023
Time: 8:00 AM Eastern Time
Participant Numbers: Toll Free: 1-833-630-1960
International: 1-412-317-1841
Webcast: https://app.webinar.net/rE345LOXL6b
CONFERENCE
REPLAY
|
|
US Toll
Free:
|
1-877-344-7529
|
International
Toll:
|
1-412-317-0080
|
Replay Access
Code:
|
4657227
|
End Date:
|
August 21,
2023
|
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
hydrochloride for Injection/Hepatic Delivery System) and
CHEMOSAT® Hepatic Delivery System for Melphalan
percutaneous hepatic perfusion (PHP) 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.