Delcath Systems, Inc. Announces Positive Outcomes from Independent Study on Hepatic Perfusion for Uveal Melanoma Patients
August 27 2024 - 8:30AM
Business Wire
Delcath Systems, Inc. (Nasdaq: DCTH) (the “Company” or
“Delcath”), an interventional oncology company specializing in the
treatment of primary and metastatic liver cancers, today announced
the publication of a retrospective study by independent
investigators in the Annals of Surgical Oncology. The study, titled
“Hepatic and Overall Progression-Free Survival After Percutaneous
Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for
Metastatic Uveal Melanoma,” was conducted by researchers at Moffitt
Cancer Center in Tampa, Florida. The 30-patient study reported that
Delcath’s HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS))
provided better disease control in the liver and improved
progression-free survival in patients with hepatic metastases from
uveal melanoma, compared to both immunotherapy and other
liver-directed therapies.
Key Findings from the Study:
- Overall Survival (OS): The study reported median OS of
22.4 months for patients treated with HEPZATO KIT as a first-line
therapy (N=17) and 18.4 months as a second-line therapy (N=6).
- Hepatic Progression-Free Survival (hPFS): Patients
receiving HEPZATO KIT as first-line therapy had a median hPFS of
17.6 months (N=17), compared to 8.8 months (N=6) for immunotherapy
and 9.2 months (N=7) for other liver-directed therapies. When used
as a second-line therapy, HEPZATO KIT resulted in a median hPFS
that was not reached (N=6), showing better outcomes than
immunotherapy (14.7 months, N=5) and other liver-directed therapies
(7.5 months, N=3) in this patient cohort.
- Progression-Free Survival (PFS): The median overall PFS
was 15.4 months (N=17) for patients receiving HEPZATO KIT as
first-line therapy, compared to 8.8 months (N=6) for immunotherapy
and 9.2 months (N=7) for other liver-directed therapies. In the
second-line setting, HEPZATO KIT resulted in a median PFS of 22.2
months (N=6), compared to 14.7 months (N=5) for immunotherapy and
7.5 months (N=3) for other liver-directed therapies, reflecting
longer disease control in this group.
Jonathan Zager, MD Chief Academic Officer and Director of
Regional Therapies at Moffitt Cancer Center, remarked, “The
findings from this study reaffirm the critical role of
melphalan/HDS in managing liver-dominant metastatic uveal melanoma.
These results highlight the potential benefits melphalan/HDS offers
to patients, particularly in the context of first- and second-line
treatments. My team is committed to further exploring the potential
of combining melphalan/HDS with systemic therapies to continue
improving patient outcomes.”
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 isolate the hepatic venous blood from the
systemic circulation 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240827426026/en/
Investor Relations: ICR Westwicke
investorrelations@delcath.com
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