Delcath Systems Announces FDA Clearance Of IND Application For Phase 2 Clinical Trial Of HEPZATO In Combination With Standard Of Care In Liver-Dominant Metastatic Colorectal Cancer
Delcath Systems Announces FDA Clearance Of IND Application For Phase 2 Clinical Trial Of HEPZATO In Combination With Standard Of Care In Liver-Dominant Metastatic Colorectal Cancer
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) for liver-dominant metastatic colorectal cancer (mCRC). With the FDA's review complete, Delcath is now authorized to initiate patient enrollment.
专注于治疗原发性和转移性肝癌的介入肿瘤学公司德尔卡斯系统公司（纳斯达克股票代码：DCTH）今天宣布，美国食品药品监督管理局（FDA）已完成对该公司2期临床试验的研究性新药（IND）申请的30天审查，该试验评估了HEPZATO与肝脏占主导地位的转移性结直肠癌（SOC）联合治疗肝脏占主导地位的转移性结直肠癌（SOC）的2期临床试验 CRC)。美国食品药品管理局的审查完成后，Delcath现已获授权启动患者入组。
The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the second half of 2025. The trial's primary endpoint, hepatic progression-free survival (hPFS), is anticipated to read out by the end of 2027, while overall survival (OS), a secondary endpoint, is expected in 2028.
2期试验将评估HEPZATO与曲氟利定-替吡拉西和贝伐珠单抗联合使用与曲氟利定-替吡拉西尔和贝伐珠单抗在接受三线治疗的肝脏占主导地位的mCRC患者中的安全性和有效性。大约90名患者将参加这项随机对照试验。该研究将在美国和欧洲的20多个地点进行，患者入组预计将于2025年下半年开始。该试验的主要终点——肝脏无进展存活率（HPF），预计将在2027年底公布，而总生存期（OS），次要终点，预计将在2028年公布。
The company estimates that the total addressable market (TAM) for liver-dominant mCRC receiving third-line treatment is between 6,000 and 10,000 patients annually in the United States. This market includes patients who present with significant liver disease burden, with liver-dominant status determined through radiological and clinical criteria. By targeting this patient population, Delcath aims to provide a novel treatment option for those with limited therapeutic alternatives.
该公司估计，在美国，每年接受三线治疗的肝脏占主导地位的mCRC的总潜在市场（TAM）在6,000至10,000名之间。该市场包括肝脏疾病负担严重的患者，其肝脏占主导地位的患者是通过放射学和临床标准确定的。通过针对这些患者群体，Delcath旨在为治疗选择有限的患者提供一种新的治疗选择。
