Delcath Systems, Inc. (Nasdaq:
DCTH), an
interventional oncology company focused on the treatment of primary
and metastatic cancers of the liver, today announced an oral
presentation of positive preliminary efficacy results from its
FOCUS Phase III trial of HEPZATO™ KIT (melphalan hydrochloride for
injection/hepatic delivery system) in patients with liver dominant
metastatic ocular melanoma (mOM) at the American Society of
Clinical Oncology (ASCO) Annual Meeting being held virtually June
4-8, 2021.
The oral presentation by Dr. Jonathan Zager, Director of
Regional Therapies and Chief Academic Officer, Moffitt Cancer
Center; Professor and Chair, Department of Oncologic Sciences, USF
Morsani College of Medicine, presented previously announced
preliminary data based on 79 of 91 treated HEPZATO patients.
Patient level response data were also presented for this same
patient set, indicating that 44% of evaluable patients in the
HEPZATO arm had a 30% or greater reduction in target tumor lesions
at one or more time points versus 17% for patients enrolled in the
Best Alternative Care arm. Dr. Sapna Patel, Associate Professor and
Uveal Melanoma Program Director, Department of Melanoma Medical
Oncology, MD Anderson Cancer Center, the discussant for the
session, provided valuable perspective regarding both the efficacy
and safety preliminary results.
Delcath CEO Gerard Michel stated, “The oral presentation by Dr.
Zager covered previously announced preliminary data showing an
overall response rate of 29.2% with a 95% confidence interval lower
bound of 20%. Given the magnitude by which the lower bound exceeds
the 8.3% prespecified threshold for success, we can confidently
state the primary endpoint has been met regardless of the outcome
of patients who have not yet been evaluated.”
Mr. Michel added, “Importantly, the 44% Best Overall Response,
combined with the previously disclosed statistically significant
improvement over Best Alternative Care in Progression Free Survival
and Disease Control Rate, further strengthens the case that HEPZATO
would offer a compelling clinical benefit to patients were it
approved by FDA.”
The material presented at ASCO, as well as additional data from
the preliminary analysis of the FOCUS trial, is available on the
Company's website.
Q&A Webinar
The company invites investors to join a Q&A webinar
today at 8:30am ET, hosted by Gerard Michel,
CEO. Mr. Michel will review the company and its strategy,
as well as discuss these positive preliminary results from its
Phase 3 FOCUS Trial of HEPZATO in patients with metastatic ocular
melanoma. Management will also provide answers on the live call to
any questions submitted by attendees. Participants will be able to
listen to the webinar and submit questions via the “ask a question”
tab, during the live event or can email questions
to investorrelations@delcath.com before
the event. To participate in this event, connect approximately 5 to
10 minutes before the beginning of the call.
Webinar
Link: https://www.webcaster4.com/Webcast/Page/2475/41223
To Join By Phone:Toll Free: 888-506-0062International:
973-528-0011Conference Entry Code: 815206
About Delcath Systems, Inc., HEPZATO and
CHEMOSAT
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, 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. CHEMOSAT is being marketed under an exclusive
licensing agreement with medac GmbH, a privately held
multi-national pharmaceutical company headquartered in Germany that
specializes in the treatment and diagnosis of oncological,
urological and autoimmune diseases.
About the FOCUS Trial and the Preliminary
Analysis
HEPZATO is being studied in the FOCUS trial which is a
single-arm, multi-center, open-label trial to treat patients with
hepatic-dominant metastatic ocular melanoma (mOM). The FOCUS Trial
is being conducted at approximately 30 sites in the United
States and Europe. The primary endpoint of the FOCUS
Trial is Objective Response Rate (ORR) as measured by RECISTv1.1,
in the Intent to Treat (ITT) population. The single arm trial was
powered to demonstrate a superior ORR versus checkpoint inhibitors,
one of the few mOM treatment categories with a significant amount
of peer reviewed publications. The checkpoint inhibitor ORR was
calculated based on a meta-analysis covering 16 different
publications which included 476 patients. The pooled overall
response rate was 5.5% [95% CI: 3.6, 8.3]. To achieve statistical
significance at a 95% Confidence Interval the lower bound of the
ORR for HEPZATO is required to exceed the 8.3% upper bound of
the meta-analysis.
Secondary endpoints include Duration of Response (DOR), Disease
Control Rate (DCR), Overall Survival (OS), and Progression-Free
Survival (PFS). Additional exploratory outcome measures include
time to objective response, hepatic progression-free survival,
hepatic objective response, and quality of life, safety, and other
pharmacokinetic measures. Initially, the trial was a randomized
controlled trial which was amended to a single arm trial given slow
enrollment due to the rarity of ocular melanoma, absence of
crossover to the experimental trial arm, competing clinical trials
and the commercial availability of CHEMOSAT in Europe.
Included in the prespecified analyses are comparisons against the
Best Alternative Care (BAC) arm which enrolled 32 patients prior to
the amendment to a single-arm trial.
On March 31, 2021 Delcath released a preliminary
analysis of the FOCUS trial data using prespecified analyses based
on a data cut on March 12, 2021 which included 87% of treated
patients. An Independent Review Committee assessed an ORR of 29.2%
[95% CI: 20.1, 39.8] in the ITT population, the lower bound of
which exceeded the upper bound of the predefined success criteria
(8.3%) for the primary ORR endpoint. In the per protocol
populations, evaluable patients in the HEPZATO arm had a
statistically significant improvement over BAC in prespecified
endpoints including: ORR of 32.9% [95% CI: 22.8, 44.4] versus 13.8%
[CI: 3.9, 31.7] for the BAC arm (Chi-square P<0.05), Median PFS
of 9.0 months [95% CI: 6.2, 11.8] versus 3.1 months ([95% CI: 2.7,
5.7] for the BAC arm (HR=0.41 p<0.001), and DCR of 70.9% [95%
CI: 59.6, 80.6] versus 37.9% [95% CI: 20.7, 57.7] for the BAC arm
(p<0.002). In this preliminary analysis, DOR and OS were not yet
evaluable. Since not all patients were evaluable for all time
points, these preliminary analyses may change as data matures.
In the HEPZATO safety population of 94 patients, 38 patients
(40.4%) experienced a treatment-emergent serious adverse event. The
most commonly reported treatment-emergent serious adverse events
were thrombocytopenia (14.9% of patients), neutropenia (10.6% of
patients), and leukopenia (4.2% of patients), which were
well-manageable. 5% of patients experienced treatment-emergent
serious cardiac adverse events. In all cases the events resolved
with no ongoing complications. There were no treatment-related
deaths in the trial.
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 mOM and ICC clinical trial programs, as
well as the receipt of additional data and the performance of
additional analyses with respect to the mOM clinical trial, our
determination whether to continue the ICC clinical trial program or
to focus on other alternative indications, and timely monitoring
and treatment of patients in the global Phase 3 mOM clinical trial
and the impact of the COVID-19 pandemic on the completion of our
clinical trials; 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)-755-7412 james@haydenir.com
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