Significantly Higher Overall Response Rate vs
Meta-analysis of Historical Controls (36.3% vs. 5.5%)
Other Efficacy Endpoints Include a 73.6%
Disease Control Rate with a 7.7% Complete Response Rate
NEW
YORK, May 6, 2024 /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 results from the
pivotal Phase 3 FOCUS study of HEPZATO KIT (melphalan/Hepatic
Delivery System) in patients with unresectable metastatic Uveal
Melanoma (mUM) on May 5, 2024 in the
journal Annals of Surgical Oncology.
The Food and Drug Administration (FDA) approved HEPZATO KIT on
August 14, 2023 based on the results
from the pivotal FOCUS study. A total of 91 patients with
unresectable mUM were treated with HEPZATO KIT at 23 treatment
centers in the US and Europe.
Preliminary results from the FOCUS study were presented at the
American Society of Clinical Oncology Annual Meeting in 2022.
The FOCUS study was designed to provide a robust evaluation of
efficacy and safety of HEPZATO KIT treatment, and enrolled a
heterogeneous mUM patient population, including treatment-naïve and
pretreated patients, patients with and without extrahepatic disease
and patients with a range of baseline tumor burden.
The primary efficacy endpoint of the FOCUS study was Overall
Response Rate (ORR), which was 36.3%, including 7.7% of patients
with Complete Response (CR), as determined by an Independent Review
Committee. 37.4% of patients had Stable Disease (SD). ORR achieved
in the FOCUS study was compared to a Meta-analysis of historic
data, encompassing 16 published clinical studies with a total of
476 mUM patients treated with contemporary immunotherapy drugs. ORR
of 36.3% in the FOCUS study was statistically significantly better
than the pooled ORR estimate (a weighted mean of the observed ORR)
of 5.5% in the historical control group.
Secondary efficacy endpoints included Duration of Response
(DOR), median Progression-free Survival (mPFS) and median Overall
Survival (mOS), which were 14, 9 and 20.5 months, respectively.
Safety and tolerability of HEPZATO KIT treatment reported in the
FOCUS study was comparable with published clinical experience with
Chemosat in Europe. Median number
of administered HEPZATO KIT treatment cycles in the FOCUS study was
4. The most common serious treatment-emergent adverse events (SAE)
were thrombocytopenia (15.8%) and neutropenia (10.5%), managed with
standard supportive care and resolved with no ongoing
complications. No treatment-related deaths were observed.
"My team at the Moffitt Cancer Center and I are very excited
about the publication of results from the FOCUS study. The study
results are consistent with data obtained from previous clinical
studies, as well as our own experience with percutaneous hepatic
perfusion (PHP) with more than 200 treatments performed at Moffitt
over the past 15 years," said Dr. Jonathan
Zager, MD Chief Academic Officer and Director of Regional
Therapies at Moffitt Cancer Center. "Since HEPZATO KIT became
available in January, the treatment has become the liver directed
standard of care for appropriate patients with mUM at our
institution."
"Results from the pivotal FOCUS study demonstrate that the PHP
procedure, whether utilizing the FDA approved HEPZATO KIT or
melphalan delivered by the Chemosat device available in
Europe, is an important treatment
option for patients with liver-dominant mUM," said Dr. Vojo Vukovic, MD, PhD Delcath's Chief Medical
Officer. "Delcath is looking forward to publishing additional
results from the FOCUS study later this year."
The vast majority of patients with mUM will have liver
metastases, often leading to liver failure, and the National
Comprehensive Cancer Network guidelines recommend liver-directed
therapies be considered for the treatment of mUM. HEPZATO is the
only liver-directed treatment for unresectable mUM patients
approved by the FDA.
About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
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 (Hepzato
(melphalan) 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.
In the United States, HEPZATO
KIT is considered a combination drug and device product and is
regulated and approved for sale as a drug by the FDA. HEPZATO KIT
is comprised of the chemotherapeutic drug melphalan and Delcath's
proprietary Hepatic Delivery System (HDS). The HDS is used to
surgically isolate the liver while simultaneously filtrating
hepatic venous blood during melphalan infusion and washout. The use
of the HDS results in loco-regional delivery of a relatively high
melphalan dose, which can potentially induce a clinically
meaningful tumor response with minimal hepatotoxicity and reduce
systemic exposure. 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. Please see the full Prescribing
Information, including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only
configuration of the HDS is regulated as a Class III medical device
and is approved for sale under the trade name CHEMOSAT Hepatic
Delivery System for Melphalan, or CHEMOSAT, where it has been used
in the conduct of percutaneous hepatic perfusion procedures 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 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.