Delcath Systems Announces a KOL Call on November 5, 2020 to discuss the Results of a Prospective Phase II Study in Patients w...
October 29 2020 - 7:30AM
Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology
company focused on liver-directed treatment of primary and
metastatic cancers, today announced that the Company will be
hosting a Key Opinion Leader (KOL) call with Dr. Mark Burgmans, an
Interventional Radiologist at the Leiden University Medical Center
(LUMC) in The Netherlands, on Thursday, November 5, 2020, at
11:30am ET.
Dr. Mark Burgmans will discuss results from a prospective phase
II study conducted at Leiden University Medical Center on the
use of the Delcath CHEMOSAT® Hepatic Delivery System with
Melphalan (CHEMOSAT) to treat patients with metastatic ocular
melanoma with liver metastases. The publication is entitled
“Percutaneous Hepatic Perfusion with Melphalan in Patients with
Unresectable Ocular Melanoma Metastases Confined to the Liver: A
Prospective Phase ll Study” and was published in Annals of Surgical
Oncology.1
Unlike other published and ongoing studies investigating the use
of CHEMOSAT to treat patients with metastatic ocular melanoma,
this study enrolled a patient population which had not yet
progressed to extra-hepatic metastases. In addition, for 60% of the
patients, treatment with CHEMOSAT was used in a first line
setting. The overall response rate observed in these earlier
stage patients was 72% (complete response of 3% and partial
response of 69%) with a median overall survival of 19.1
months. The investigators noted that while this prospective
study was not designed for direct comparison, the results indicate
that CHEMOSAT is more effective in treating liver metastases from
ocular melanoma than systemic therapies.
Although grade 3 or 4 hematologic events were observed in the
majority of patients, they were all well manageable or
self-limiting and there were no treatment-related deaths. In an
earlier publication of this study, the investigators noted that the
hematologic and hepatic toxicity percentages were significantly
lower compared to studies using an earlier generation of CHEMOSAT
which utilized a different filter system.2 Based on a validated
quality of life tool used in the trial, the investigators concluded
that CHEMOSAT is well-tolerated with maintenance of quality of
life, with only a mild and temporary impairment of physical
functioning noted at 6 weeks after the second CHEMOSAT
treatment.
The full article is available online at:
https://rdcu.be/b9nnn
The presentation will be live webcast
at http://investors.delcath.com/events-presentations. For
those not available to listen to the live broadcast, a replay will
be archived and available
at http://investors.delcath.com/events-presentations.
The CHEMOSAT Hepatic Delivery System is not approved in the
United States. In the United States the Melphalan/Hepatic Delivery
System is currently being investigated in a phase 3 trial in
patients with metastatic ocular melanoma.
1) Meijer, T.S., Burgmans, M.C., de Leede, E.M. et
al. Percutaneous Hepatic Perfusion with Melphalan in Patients
with Unresectable Ocular Melanoma Metastases Confined to the Liver:
A Prospective Phase II Study. Ann Surg Oncol (2020).
https://doi.org/10.1245/s10434-020-08741-x
2) Meijer, T. S., Burgmans, M. C., Fiocco, M., de Geus-Oei, L.
F., Kapiteijn, E., de Leede, E. M., Martini, C. H., van der Meer,
R. W., Tijl, F., & Vahrmeijer, A. L. (2019). Safety of
Percutaneous Hepatic Perfusion with Melphalan in Patients with
Unresectable Liver Metastases from Ocular Melanoma Using the
Delcath Systems' Second-Generation Hemofiltration System: A
Prospective Non-randomized Phase II Trial. Cardiovascular and
interventional radiology, 42(6), 841–852.
https://doi.org/10.1007/s00270-019-02177-x
Contact:
Hayden IRJames Carbonara(646)-755-7412james@haydenir.com
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