Retrospective study in metastatic uveal melanoma patients
with liver dominant disease shows an objective response rate of
59.4% and a disease control rate of 89.1%.
The study finds that achieving complete response, partial
response, or stable disease is associated with improved
survival.
NEW
YORK, Aug. 5, 2022 /PRNewswire/ -- Delcath
Systems, Inc.
(Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and
metastatic cancers of the liver, announced the publication of a
retrospective analysis of patients who underwent a percutaneous
hepatic perfusion procedure (PHP) with CHEMOSAT® at
three European centers, one in the
Netherlands and two in Germany, between February 2014 and December 2019. The study
involved 101 patients who completed a minimum of one PHP procedure for the treatment of
unresectable uveal melanoma (UM) liver metastases.
The study, Predictive Parameters in Patients Undergoing
Percutaneous Hepatic Perfusion with Melphalan for Unresectable
Liver Metastases from Uveal Melanoma: A Retrospective Pooled
Analysis, by Dr. T. M. L. Tong, et al,, included a total
of 212 PHP procedures for the 101
patients included in the study. Of the 101 patients, 66 received
PHP as first line treatment and 33 had received prior therapy
(status of 2 patients was unknown). Approximately 50% of patients
had greater than 9 metastases. Seventy-seven patients underwent at
least two procedures and 25 patients received more than
two PHP procedures. After a median
follow-up time of 15 months, a complete response (CR) was reported
in five (5.0%) patients; partial response (PR) in 55 (54.5%), and
stable disease (SD) in 30 (29.7%), resulting in an objective
response rate (ORR) of 59.4% and a disease control rate (DCR) of
89.1%.
The median progression-free survival (PFS), liver
progression-free survival (LPFS), and overall survival (OS) were
9.0 months (95% CI 7.7 -10.3); 11.0 months (95% CI 9.0 – 13.0); and
20.0 months (95% CI 13.7 – 26.3), respectively. Twelve
patients who were lost to follow-up were censored in the survival
analyses. The study also found statistically significant
differences in median PFS, median LPFS, and OS between patients who
had CR, PR, or SD; and patients with progressive disease
(PD). For example, for patients with CR or PR the median OS
was 27 months (95% CI 17.5 – 36.5); for patients with SD the median
OS was 21 months (95% CI 11.2 – 30.8); and 8 months (95% CI 5.7 -
10.3) for patients with PD.
Although the study did not find a statistically significant
difference in either median PFS and LPFS for patients treated with
two or more PHP procedures compared to patients treated with
one PHP procedures, the study did
find a statistically significant difference in OS (20 months vs. 8
months) for patients who had two or more PHP procedures compared to
patients who were treated with one
PHP procedure.
The safety analysis was conducted on the first treatment cycle
(183 PHP procedures). The most common
adverse events were hematological toxicities which were grade 1/2
and self- limiting in the majority of patients and consistent with
previous reports on PHP. Other adverse events were thromboembolic
in nature. The mortality rate was 1.1% within 30 days after
PHP.
"Delcath welcomes this publication and believes its results
provide healthcare professionals with further evidence of
Chemosat's utility in patients suffering from metastatic uveal
melanoma," said Johnny John, MD,
Delcath's Senior Vice President of Clinical Operations and Medical
Affairs. "We look forward to resubmitting the NDA for Hepzato
Kit, the combination of the Chemosat device packaged with
melphalan, to FDA by the end of the third quarter."
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.
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SOURCE Delcath Systems, Inc.