Delcath Systems Green-Lit by FDA for Phase 2 Trial in Liver-Dominant Metastatic Colorectal Cancer
Delcath Systems, Inc. (NASDAQ: DCTH), a company specializing in interventional oncology, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) treatments for liver-dominant metastatic colorectal cancer (mCRC). With this clearance, the company is authorized to begin patient enrollment.
Key Highlights of the Phase 2 Trial:
- Objective: Evaluate the safety and efficacy of HEPZATO combined with trifluridine-tipiracil and bevacizumab, compared to the SOC combination alone.
- Design: Randomized, controlled trial involving approximately 90 patients.
- Locations: Conducted at over 20 sites across the U.S. and Europe.
- Timeline: Enrollment is expected to begin in the second half of 2025. The primary endpoint, hepatic progression-free survival (hPFS), is anticipated by the end of 2027, with overall survival data expected in 2028.
The trial focuses on a targeted population of liver-dominant mCRC patients receiving third-line treatment, addressing a total addressable market estimated at 6,000 to 10,000 patients annually in the U.S.
“This Phase 2 study underscores our commitment to expanding the potential applications of HEPZATO to new indications,” said Gerard Michel, CEO of Delcath Systems. “We are dedicated to providing innovative treatment options for patients facing limited therapeutic alternatives.”
The company ended the third quarter with cash and investments of $14.0 million with quarterly cash burn of $3.6 million.
