Delcath Systems Inc. (NASDAQ:DCTH) is a specialty pharmaceutical and medical device company focused on developing and commercializing innovative therapies for patients with primary and metastatic cancers of the liver, a disease area with high unmet medical need and limited effective treatment options. Founded in 1988 and headquartered in Queensbury, New York, the company has dedicated decades to advancing targeted, organ-directed therapies designed to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure. This approach is based on the company’s proprietary percutaneous hepatic perfusion (PHP) technology, which isolates the liver’s circulatory system to allow concentrated treatment of liver tumors. Delcath’s mission has been to create a more effective and tolerable treatment alternative for cancers that predominantly spread to the liver and are often resistant to traditional systemic therapies.
The company’s lead product, HEPZATO KIT, represents the evolution of its drug-device combination platform. This system enables the delivery of melphalan, a well-known chemotherapeutic agent, directly to the liver through an innovative filtration system that removes most of the drug from the blood before it returns to the body. Originally known in Europe as CHEMOSAT, the platform has been used in multiple clinical settings and has received regulatory approval in Europe for treating liver metastases from ocular melanoma and other cancers. In the United States, Delcath secured FDA approval of HEPZATO KIT for the treatment of adult patients with uveal melanoma with unresectable hepatic metastases, providing a new therapeutic option for a patient population with historically poor survival outcomes. This approval marked a significant milestone in Delcath’s transition into a commercial-stage company, positioning it for expanding market adoption across leading cancer treatment centers.
Over the years, Delcath has formed strategic partnerships with leading oncology institutions and medical researchers to study the clinical benefits of its hepatic perfusion technology. The company’s research has extended beyond uveal melanoma to explore potential applications in other cancers with liver-dominant disease, including metastatic colorectal cancer and hepatocellular carcinoma. A key differentiator for Delcath is its focus on combining its hepatic delivery system with systemic immunotherapies, recognizing the potential to improve outcomes by enhancing immune response while directly targeting liver tumors. Through its ongoing clinical trials and commercial expansion strategy, Delcath Systems has established itself as a pioneering force in interventional oncology, with the goal of transforming liver cancer treatment and improving survival outcomes for patients worldwide.
Breakthrough Clinical Validation From the CHOPIN Phase 2 Trial
A major catalyst for Delcath is the recent release of highly positive results from the CHOPIN randomized Phase 2 clinical trial presented at the 2025 European Society of Medical Oncology (ESMO) Annual Congress. The trial evaluated Delcath’s CHEMOSAT delivery system alone versus in combination with immune checkpoint inhibitors ipilimumab and nivolumab in patients with metastatic uveal melanoma (mUM). The combination treatment achieved a one-year progression-free survival rate of 54.7 percent compared to just 15.8 percent in the PHP-only group, with a hazard ratio of 0.34 and p-value under 0.001, reflecting extraordinary clinical significance. Median progression-free survival improved from 8.3 months to 12.8 months with the combination therapy, while the best overall response rate increased from 39.5 percent to 76.3 percent. These outcomes demonstrate not only superiority in tumor control but also provide robust validation for Delcath’s liver-directed treatment platform when combined with systemic immunotherapies.
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Surging Survival Outcomes Signal Broad Clinical Impact
Overall survival results were equally compelling. One-year survival rates exceeded 82 percent in both arms, but two-year survival nearly doubled in the combination group at 49.6 percent compared to 22.1 percent in the PHP-only arm, with median overall survival extending to 23.1 months versus 19.6 months. While grade 3 or higher adverse events were more frequent in the combination arm (81.6 percent versus 40.5 percent), they were deemed manageable and consistent with expected profiles for checkpoint inhibitors. Importantly, no new safety concerns were identified, positioning Delcath’s treatment regimen as a powerful and tolerable therapy that may soon transform standard of care for liver-dominant cancers. These findings not only support rapid adoption in uveal melanoma but also suggest potential application across multiple solid tumors with liver metastases, including non-small-cell lung cancer and renal cell carcinoma.
Commercial Tailwinds and Expanding Market Opportunity
Delcath’s platform is already FDA-approved as HEPZATO KIT™ for the treatment of adult patients with uveal melanoma with unresectable hepatic metastases and limited liver involvement. The approval allows administration every six to eight weeks for up to six treatments, creating a recurring revenue model with high gross margins in the 80 to 90 percent range. The company’s CHEMOSAT system has also gained traction in Europe, contributing to early-stage commercial revenue. Over the last year, Delcath’s revenue and treatment volumes have accelerated significantly as more oncology centers integrate the HEPZATO KIT into clinical practice. Management expects substantial growth in patient adoption due to strong clinical data, increased procedural training among interventional oncologists, and rising awareness of liver-directed therapies among oncologists who traditionally start with systemic immunotherapies.
Positioned for Long-Term Expansion and Cross-Tumor Applications
What sets Delcath apart from traditional biotech companies is its drug-device hybrid model that creates durable competitive advantages and raises barriers to entry. The CHOPIN trial results highlight synergistic potential between Delcath’s hepatic perfusion system and leading immunotherapies, unlocking future opportunities to expand into larger cancer indications. Given that liver metastases typically lead to poor outcomes when treated with systemic checkpoint inhibitors alone due to the liver’s immunosuppressive microenvironment, Delcath’s ability to enhance immunotherapy efficacy may position the company at the forefront of a new treatment class. This could vastly expand its addressable market beyond uveal melanoma into much larger patient populations, driving exponential revenue growth over the next decade.
Conclusion: A High-Growth Oncology Company Entering Its Inflection Point
Delcath Systems is transitioning from a development-stage company into a commercially validated leader in interventional oncology. With groundbreaking CHOPIN Phase 2 data, accelerating adoption of the HEPZATO KIT, and clear opportunities to expand indications, Delcath is positioned for rapid growth, margin expansion, and significant shareholder value creation. Its proprietary technology, strong clinical outcomes, and increasing global footprint establish Delcath as a transformative force in liver cancer treatment and a high-conviction opportunity for investors looking for innovative oncology exposure with near-term revenue potential and long-term scalability.
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