Independent Investigator Study Compared Two Liver Directed Therapies in Patients with Metastatic Uveal Melanoma

独立研究者研究比较了两种肝脏导向治疗转移性葡萄膜黑色素瘤的疗效

Significantly Longer Overall Survival for Patients Treated with Chemosat vs. SIRT (516 and 301 days, respectively; p=0.006)

Chemosat与SIRT治疗组患者的总生存期显着延长（分别为516天和301天；p=0.006）

NEW YORK, Sept. 11, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced the details of an oral presentation by independent investigators on September 9, 2023 at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting held in Copenhagen, Denmark..

纽约，2023年9月11日/PRNewswire/-Delcath Systems，Inc。（纳斯达克股票代码：DCTH）是一家专注于治疗原发性和转移性肝癌的介入性肿瘤公司，今天宣布了口头陈述的细节由独立调查人员于9月9日，2023年在丹麦哥本哈根举行的欧洲心血管和介入放射学会（CIRSE）年会上。。

Uveal melanoma usually shows a liver-dominant metastasis spread and is often treated with liver directed therapies. The retrospective study presented at CIRSE compared two cohorts of patients with liver dominant uveal melanoma treated at the University Hospital Tubingen, Germany with multiple cycles of either transarterial radioembolization (SIRT, N=34) or chemosaturation-percutaneous hepatic perfusion (Chemosat or CS-PHP, N=28).

葡萄膜黑色素瘤通常显示肝脏占优势的转移扩散，并且通常用肝脏指导的疗法治疗。在CIRSE上进行的回顾性研究比较了在德国图宾根大学医院接受治疗的两组肝脏占优势的葡萄膜黑色素瘤患者，其中多个周期的经动脉放射栓塞（SIRT，N=34）或化学饱和经皮肝灌注（Chemosat或CS-PHP），N=28）。

Objective tumor response (ORR) rates were 5% and 9%, for SIRT and CS-PHP, respectively. Median overall survival (mOS) was 301 days for SIRT and 516 days for CS-PHP, the adjusted Cox regression analysis showed a significant difference (p=0.006). Median progression-free survival (mPFS) was 127.5 days for SIRT and 408.5 days for CS-PHP; the adjusted Cox regression analysis showed a trend favoring CS-PHP without reaching statistical significance (p=0.090)..

SIRT和CS-PHP的客观肿瘤反应率（ORR）分别为5%和9%。SIRT的中位总生存期（mOS）为301天，CS-PHP为516天，调整后的Cox回归分析显示有显着性差异（p=0.006）。SIRT的中位无进展生存期（mPFS）为127.5天，中位无进展生存期（mPFS）为408.5天对于CS-PHP；调整后的Cox回归分析显示有利于CS-PHP而未达到统计学显着性的趋势（p=0.090）。。

'Liver directed treatment, including transarterial radioembolization and CS-PHP, is a critical treatment modality for patients with metastatic uveal melanoma,' stated presenting author Prof. Dr. Med. Gerd Groezinger, from the University of Tubingen. 'Given the longer overall survival seen in the CS-PHP cohort, we conclude that for metastatic uveal melanoma patients, CS-PHP might be the superior liver directed treatment option.'.

图宾根大学的作者Med.Gerd Groezinger博士说：“肝定向治疗，包括经动脉放射栓塞和CS-PHP，是转移性葡萄膜黑色素瘤患者的关键治疗方式。”鉴于在CS-PHP队列中观察到更长的总生存期，我们得出结论，对于转移性葡萄膜黑色素瘤患者，CS-PHP可能是优越的肝脏指导治疗选择。

'The presentation of these results adds to the growing body of evidence that the PHP procedure, whether utilizing melphalan delivered by Delcath's CE marked Chemosat or the FDA approved HEPZATO KIT, is an important treatment option for patients with liver-dominant uveal melanoma,' said Dr. Vojo Vukovic, Delcath's Chief Medical Officer.

“这些结果的呈现增加了越来越多的证据表明，PHP程序，无论是使用Delcath CE标记的Chemosat提供的美法仑还是FDA批准的HEPZATO试剂盒，都是肝脏占优势的葡萄膜黑色素瘤患者的重要治疗选择，”Delcath首席医疗官Vojo Vukovic博士说。

'We look forward to making this treatment option available to patients in the US later this year.'.

“我们期待今年晚些时候为美国患者提供这种治疗方案。”。

About Chemosat and HEPZATO KIT

关于Chemosat和HEPZATO试剂盒

CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) is designated under the medical device regulation for use in Europe and the United Kingdom. The Hepatic Delivery System (HDS) is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. The use of the HDS allows a healthcare provider team to surgically isolate the liver while the hepatic venous blood is filtered during melphalan infusion and subsequent washout during a Percutaneous Hepatic Perfusion (PHP) procedure.

用于美法仑经皮肝脏灌注（PHP）的CHEMOSAT肝脏输送系统根据医疗器械法规指定用于欧洲和英国。肝脏输送系统（HDS）设计用于对肝脏进行高剂量化疗，同时控制PHP过程中的全身暴露和相关副作用。HDS的使用允许医疗保健提供者团队手术分离肝脏，同时在美法仑输注期间过滤肝静脉血并随后在经皮肝灌注（PHP）过程中冲洗。

PHP, which can only be performed with Delcath's HDS, results in loco-regional delivery of a relatively high melphalan dose.. For more information regarding CHEMOSAT and its use, please visit Chemosat.com..

PHP只能使用Delcath的HDS进行，导致局部区域递送相对较高的美法仑剂量。。有关CHEMOSAT及其使用的更多信息，请访问CHEMOSAT.com。。

HEPZATO KIT (melphalan for Injection/Hepatic Delivery System), approved for use in the United States by FDA, is a combination drug/device product which administers HEPZATO (melphalan) directly to the liver through the HDS, which permits higher drug exposure in target tissues while limiting systemic toxicity..

HEPZATO试剂盒（melphalan for Injection/Hepatic Delivery System），经FDA批准在美国使用，是一种组合药物/装置产品，通过HDS将HEPZATO（美法仑）直接施用于肝脏，从而允许更高的药物暴露在靶组织中，同时限制全身毒性。。

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..

HEPZATO-KIT在美国被批准用于成人转移性葡萄膜黑色素瘤（mUM）的肝脏指导治疗，其具有不可切除的肝转移，影响不到50%的肝脏并且没有肝外疾病，或仅限于骨骼的肝外疾病，淋巴结，皮下组织或肺部，适合切除或放疗。。

HEPZATO KIT Important Safety Information

HEPZATO套件重要的安全信息

Patients eligible for HEPZATO should NOT have any of the following medical conditions:

符合HEPZATO条件的患者不应患有以下任何疾病：

Active intracranial metastases or brain lesions with a propensity to bleed

活动性颅内转移或有出血倾向的脑损伤

Liver failure, portal hypertension, or known varices at risk for bleeding

肝功能衰竭，门静脉高压症或已知有出血风险的静脉曲张

Surgery or medical treatment of the liver in the previous 4 weeks

前4周肝脏手术或内科治疗

Active cardiac conditions including unstable or severe angina or myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease

活动性心脏病，包括不稳定或严重的心绞痛或心肌梗塞），恶化或新发充血性心力衰竭，严重的心律失常或严重的瓣膜病

History of allergies or known hypersensitivity to melphalan or a component or material utilized within the HEPZATO KIT including natural rubber latex, heparin, and severe hypersensitivity to iodinated contrast not controlled by antihistamines and steroids

过敏史或已知过敏美法仑或HEPZATO试剂盒中使用的成分或材料，包括天然橡胶乳胶、肝素，以及严重过敏碘对比剂，不受抗组胺药和类固醇控制

Most common adverse reactions or laboratory abnormalities occurring with HEPZATO treatment are thrombocytopenia, fatigue, anemia, nausea, musculoskeletal pain, leukopenia, abdominal pain, neutropenia, vomiting, increased alanine aminotransferase, prolonged activated partial thromboplastin time, increased alkaline phosphatase, increased aspartate aminotransferase and dyspnea..

HEPZATO治疗中最常见的不良反应或实验室异常是血小板减少症，疲劳，贫血，恶心，肌肉骨骼疼痛，白细胞减少，腹痛，中性粒细胞减少，呕吐，丙氨酸氨基转移酶增加，活化部分促凝血酶原激酶时间延长，碱性磷酸酶增加，天冬氨酸氨基转移酶增加和呼吸困难。。

Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur via hepatic intra-arterial administration of HEPZATO. HEPZATO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS.

严重的围手术期并发症包括出血，肝细胞损伤和血栓栓塞事件可能通过肝动脉内给予HEPZATO发生。HEPZATO只能通过名为HEPZATO KIT REMS的风险评估和缓解策略的限制性计划提供。

Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Additional cycles of HEPZATO therapy will be delayed until blood counts have improved..

HEPZATO可能会发生严重感染，出血或症状性贫血的骨髓抑制。HEPZATO治疗的其他周期将延迟到血细胞计数改善。。

Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.

请参阅完整的处方信息，包括HEPZATO套件的盒装警告。

About Delcath Systems, Inc.

关于Delcath系统公司。

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 (melphalan for Injection/Hepatic Delivery System), approved for use in the United States by FDA, and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), designated under the medical device regulation for use in Europe and the United Kingdom, are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure..

Delcath Systems，Inc.是一家专注于治疗原发性和转移性肝癌的介入肿瘤学公司。该公司的专有产品HEPZATO KIT（美法仑注射液/肝脏输送系统）已获FDA批准在美国使用，CHEMOSAT肝脏输送系统用于美法仑经皮肝脏灌注（PHP），根据医疗器械法规指定用于欧洲和英国，旨在对肝脏进行大剂量化疗，同时控制PHP手术过程中的全身暴露和相关副作用。。

Forward Looking Statements

前瞻性声明

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 press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described.

1995年“私人证券诉讼改革法”为公司或其代表所作的前瞻性陈述提供了一个安全港。本新闻稿包含前瞻性声明，这些声明受到某些风险和不确定性的影响，可能导致实际结果与所描述的结果大不相同。

The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“预期”，“相信”，“继续”，“可能”，“估计”，“期望”，“打算”，“可能”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“将会”和类似的表达方式是为了识别前瞻性陈述，尽管并非所有的前瞻性陈述都包含这些识别词语。

Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential  benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT.  For additional information about these factors, and others that may impact the Company, please see the Company's filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K.

可能导致这种差异的因素包括但不限于以下方面的不确定性：公司的商业化计划及其成功商业化HEPZATO套件的能力；公司成功管理HEPZATO套件供应链，包括确保制造和组装HEPZATO套件所需的关键组件的充足供应；FDA成功检查了公司及其第三方供应商/制造商的设施；公司成功实施和管理HEPZATO KIT风险评估和缓解策略；HEPZATO试剂盒作为肝脏原发性和转移性疾病患者治疗的潜在益处；公司获得HEPZATO套件报销的能力；以及公司与HEPZATO套件用户成功签订任何必要的采购和销售协议的能力。有关这些因素以及可能影响公司的其他因素的更多信息，请参阅公司向证券交易委员会提交的文件，包括表格10-K，10-Q和8-K。

Howe.

豪伊。

Contact:

联系方式：

Investor Relations Contact:Ben ShamsianLytham Partners646-829-9701[email protected]

投资者关系联系人：Ben ShamsianLytham Partners646-829-9701[电子邮件保护]

SOURCE Delcath Systems, Inc.

SOURCE Delcath Systems，Inc。