Delcath Systems has announced that the US Food and Drug Administration (FDA) has completed its 30-day review of the company’s investigational new drug (IND) application for a phase two clinical trial evaluating Hepzato in combination with standard of care for liver-dominant metastatic colorectal cancer (mCRC). With the US FDA’s review completion, Delcath Systems is now authorised to initiate patient enrolment, a press release states.
The 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 the randomised controlled trial. The study will take place at more than 20 sites across the USA and Europe, with patient enrolment 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.
The company estimates that the total addressable market for liver-dominant mCRC receiving third-line treatment is between 6,000 and 10,000 patients annually in the USA. 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 Systems aims to provide a novel treatment option for those with limited therapeutic alternatives.
“This phase two trial represents an exciting step forward in evaluating Hepzato as a treatment for patients with liver-dominant metastatic colorectal cancer,” said Gerard Michel, chief executive officer of Delcath Systems. “The study reflects our commitment to expand the potential applications of Hepzato beyond metastatic uveal melanoma, offering new hope to an additional group of patients with liver dominant cancers.”
