Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, today announced positive results from the phase 3
FOCUS study. The FOCUS study’s intent-to-treat (ITT) population was
comprised of a total of 102 subjects, across various lines of
therapy. Of the ITT group, 91 evaluable patients were administered
at least one study treatment.
Treatment with HEPZATO in the ITT analysis
resulted in an objective-response-rate (ORR) of 31.4% [95% CI:
22.55-41.31], including 6.9% of patients with a complete response
(CR). Median duration of response was 14 months [95% CI: 8.54, NC],
with over half of responders continuing to be monitored for
progression events. Disease control rate (DCR) was 65.7% [95% CI,
55.63, 74.81].
On the primary ORR endpoint, the lower bound 95%
Confidence Interval (CI) of 22.55% exceeded the FOCUS trial’s
prespecified 8.3% upper bound 95% CI threshold for success. This
threshold was derived from a meta-analysis of sixteen checkpoint
inhibitor publications documenting the treatment of 476 metastatic
ocular melanoma patients.
Supportive, predefined, exploratory analyses
were conducted comparing patients in the HEPZATO arm versus a BAC
group. The BAC arm was comprised of a total of 42 patients,
originally randomized in the FOCUS trial prior to its amendment, in
consultation with FDA, to a single-arm pivotal study in 2018. The
evaluable BAC subjects were treated predominantly with
liver-targeted Transarterial Chemoembolization (TACE).
Among patients who received at least one study
treatment, patients in the HEPZATO arm had statistically
significant improvements over BAC in the following prespecified
endpoints:
- ORR of
35.2% versus 12.5% for the BAC arm (p=0.0154).
- Disease
Control Rate of 73.6% versus 37.5% for patients in the BAC arm
(p=0.0002).
- Median
Progression Free Survival of 9.03 months versus 3.12 months for the
BAC arm (HR=0.39; p=0.0002).
Enrollment in the FOCUS trial HEPZATO arm ended
in late 2020 with overall survival data continuing to mature. Per
the statistical plan, a final predefined exploratory survival
analysis, versus BAC, will be conducted at 24-months after last
patient last treatment.
As of this analysis, survival at 12-months in
the evaluable patients was 75% in the HEPZATO arm versus 47% for
BAC [HR=0.37, p=0.01]. Delcath will provide future overall survival
analysis updates, as patient follow-up continues, and the
Kaplan-Meier analysis matures.
In the HEPZATO safety population, the most
commonly reported treatment-emergent serious adverse events were
anemia (29.7% of patients), thrombocytopenia (26.4% of patients)
and neutropenia (19.8% of patients), which were well-manageable.
5.3% 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.
“Metastatic ocular melanoma is a disease with a
dismal prognosis and new therapies are urgently needed. The FOCUS
study results, along with the predefined analyses versus a relevant
BAC group, clarify HEPZATO overall clinical benefit in this
difficult-to-treat patient population,” noted Dr. Jonathan Zager MD
FACS, global lead investigator of the FOCUS study, senior member
and Director of Regional Therapies at Moffitt Cancer Center. “The
overall efficacy, coupled with an improved safety profile versus
the first-generation product, suggests that HEPZATO would
offer a compelling clinical benefit were it approved by FDA.”
“We are thrilled by the HEPZATO response rates
and duration of response which far exceed that which has been seen
with other agents in this difficult-to-treat patient population.
Our data further highlights HEPZATO’s potential superiority to
other available liver-targeted therapies, which suggests a broader
utility for our platform across multiple liver-metastatic tumor
types. In addition to re-filing our NDA by mid-2022, Delcath, along
with key opinion leaders, intend to study HEPZATO in additional
indications in the near future.”
The FOCUS trial results will be presented at a comprehensive
Investor Update Meeting taking place today from 10:00am EST –
1:30pm EST. In addition to the FOCUS trial, a distinguished panel
of physicians will discuss their personal clinical experience with
HEPZATO in both the clinical trial setting and the commercial
setting in Europe, as well as the potential for HEPZATO to treat
liver metastatic tumor types beyond metastatic ocular melanoma.
Event Details:
Event: Delcath Systems Virtual Investor Update
MeetingDate: Thursday, December 2, 2021Time: 10:00am –
1:30 p.m. EST
To register for this event, please
click here.
The live webcast of the event may be accessed through
the Events and Presentation page
of Delcath’s website, under the Investors section. The archived
webcast and presentation will be available on the Company’s website
after the event.
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 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.
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)-755-7412james@haydenir.com
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