Positive Initial Results from CHOPIN Phase 1b Trial, FOCUS Trial Update and QoL Study Presented at the 2022 ASCO Annual Meeting
June 06 2022 - 3:15PM
Delcath Systems, Inc. (Nasdaq:
DCTH), an
interventional oncology company focused on the treatment of primary
and metastatic cancers of the liver, today announced further
details regarding presentations relating to its proprietary
percutaneous hepatic perfusion (PHP) system at the American Society
of Clinical Oncology (ASCO) Annual Meeting being held June 3-7,
2022, in Chicago, Illinois and virtually.
Initial CHOPIN Trial Results
The goal of the CHOPIN trial is to study the safety and
potential synergistic effects of systemic immunotherapy ipilimumab
plus nivolumab (IPI+NIVO) when combined with Delcath’s proprietary
liver-targeted PHP treatment in metastatic uveal melanoma patients.
The poster presented initial safety and efficacy results from the
Phase 1b portion of the trial which enrolled seven patients who
were treated with two courses of six-weekly PHPs (melphalan 3mg/kg,
max 220mg) combined with four courses IPI+NIVO three-weekly
escalating the dosing from 1mg/kg each IPI+NIVO (cohort 1) to IPI
1mg/kg + NIVO 3mg/kg (cohort 2). The poster reports a Best Overall
Response of 1 complete response, 5 partial responses and 1 stable
disease accounting for an Objective Response Rate of 85.7%. At a
median follow up time of 20.2 months, 4 patients have an ongoing
response. Currently the median progression free survival is 22.4
months, and all patients are still alive.
“Initial CHOPIN data suggests that combining Delcath’s
proprietary PHP liver targeted therapy with systemic immunotherapy
is tolerated and can potentially achieve promising overall disease
control rates in patients that otherwise would have limited
treatment options. Uveal melanoma predominantly metastasizes to the
liver and to date, the efficacy of immunotherapy in achieving
meaningful disease control rates in this setting has been limited,”
said Johnny John, MD Delcath’s Senior Vice President of Clinical
Development and Medical Affairs. “We are excited by the results of
the Phase 1b portion of the study and look forward to the
additional study of this this combination therapy to address both
hepatic and extra hepatic lesions and meaningfully alter the course
of this disease.”
Updated FOCUS Trial Results
Updated efficacy and safety results from the single-arm phase 3
FOCUS trial in metastatic uveal melanoma including Overall Response
Rate (ORR), median Duration of Response (mDOR), Disease Control
Rate (DCR), median Progression Free Survival (mPFS) and Overall
Survival (OS) data were presented that were largely consistent with
prior presentations. In addition, predefined exploratory analyses
comparing PHP to a Best-Alternative-Care (BAC) arm enrolled prior
to the trial’s protocol amendment to a single-arm study were
included.
Updated values reflect the latest data from clinical sites. OS
data continues to mature with a final, predefined analysis expected
in May 2023, two years after the study’s last treatment. As of last
analysis the FOCUS trial results are as follows:
- A 36.3% ORR in the
Treated Population, including 8% Complete Responses (CR) with a
mDOR of 14 months. A DCR of 73.6%, a median PFS of 9.03 months and
a median OS of 19.25 months.
- PHP analyses
against the BAC arm yielded statistically significant (p<0.05)
results on ORR (36.3% vs. 12.5%), DCR (73.6% vs. 37.5%) and mPFS
(9.03 months vs. 3.12).
- While OS data
continues to mature, as of the last analysis, the median OS for the
PHP arm is 19.25 months vs. 14.49 months for BAC (HR=0.70, p=0.14).
Final analysis expected in 2023.
Retrospective Quality of Life Analysis
This abstract reported on a retrospective analysis in the change
of Quality of Life (QoL) using the Functional Assessment of Cancer
Therapy – General scores for 13 PHP treated patients at the
University of Southampton. The analysis found no significant
difference in QoL score on discharge post procedure versus baseline
(prior to treatment) and noted a trend for overall improved QoL on
day 28 from baseline.
Additional details about these three PHP-related ASCO
presentations can be found below:
Title: Safety and efficacy of combined
melphalan percutaneous hepatic perfusion (M-PHP) and ipilimumab
plus nivolumab (IPI+NIVO) in metastasized uveal melanoma: First
results of the phase Ib part of the CHOPIN trial.Session
Title: Melanoma/Skin CancersSession Date and
Time: June 6, 2022, 1:15-4:15 PM CDT
(Display)Abstract
Number: 9560Presenter: Thaïs
M.L. Tong Leiden University Medical Center, Department of Medical
Oncology/Radiology, Leiden, Netherlands
Title: FOCUS Phase 3 Trial Results:
Percutaneous Hepatic Perfusion (PHP) With Melphalan for Patients
With Ocular Melanoma Liver Metastases
(PHP-OCM-301/301A)Session
Title: Melanoma/Skin CancersSession Date and
Time: June 6, 2022, 1:15-4:15 PM CDT (Display) and
4:30-6:30 PM CDT (Discussion)Abstract
Number: 9510Presenter: Dr.
Jonathan Zager, Director of Regional Therapies and Chief Academic
Officer, Moffitt Cancer Center; Professor and Chair, Department of
Oncologic Sciences, USF Morsani School of Medicine.
The Poster will be available
at https://delcath.com/investors/events-presentations/.
Title: Temporal evolution in
quality-of-life following melphalan percutaneous hepatic perfusion
for patients with metastatic uveal melanoma.Session
Title: Melanoma/Skin CancersAbstract
Number: e21520Presenter: Ganesh
Vigneswaran University of Southampton, Southampton, United
Kingdom
Visit the ASCO Annual
Meeting website for further information
regarding the conference.
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, for the treatment
of patients with unresectable hepatic-dominant metastatic ocular
melanoma (mOM), also known as metastatic uveal melanoma (mUM) 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 now regulated as a Class lll
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.
Contact:
Delcath Investor Relations
Email: investorrelations@delcath.com
Hayden IR
James
Carbonara(646)-755-7412james@haydenir.com
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