Delcath Systems Secures Key Guideline Recognition for CHEMOSAT in Uveal Melanoma Treatment
Delcath Systems, Inc., an interventional oncology company specializing in liver-directed cancer therapies, has announced a significant milestone for its proprietary CHEMOSAT® Hepatic Delivery System for Melphalan. The therapy, commonly referred to as melphalan percutaneous hepatic perfusion (M-PHP), has been formally included as a recommended liver-directed regional therapy in the latest Uveal Melanoma Clinical Practice Guidelines developed by ESMO–EURACAN and published in April 2026.
This development represents a meaningful advancement for patients suffering from metastatic uveal melanoma (mUM), particularly those with liver-dominant disease, and underscores the growing clinical acceptance of Delcath’s innovative therapeutic approach.
Understanding Uveal Melanoma and Its Challenges
Uveal melanoma is a rare but aggressive form of cancer that originates in the eye. Despite its rarity, it carries a high risk of metastasis, particularly to the liver. In fact, up to 90% of patients with metastatic uveal melanoma eventually develop liver metastases, making hepatic involvement the central clinical challenge in managing this disease.
Historically, treatment options for metastatic uveal melanoma have been limited, especially for patients whose disease is primarily confined to the liver. Systemic therapies have shown modest benefit in many cases, creating a critical need for effective liver-directed treatment strategies.
CHEMOSAT and M-PHP: A Targeted Liver-Directed Approach
Delcath’s CHEMOSAT system delivers high-dose chemotherapy directly to the liver while minimizing systemic exposure. The procedure, known as M-PHP, involves isolating the liver’s blood supply and administering melphalan in a controlled manner. This approach allows oncologists to intensify treatment within the liver while reducing the toxic side effects typically associated with systemic chemotherapy.
The therapy has gained increasing attention due to its ability to address liver-dominant disease, which is the primary driver of mortality in metastatic uveal melanoma patients.
Inclusion in ESMO–EURACAN Clinical Practice Guidelines
The inclusion of M-PHP in the updated ESMO–EURACAN Clinical Practice Guidelines marks a major validation of the therapy’s clinical utility. These guidelines are widely respected across Europe and globally, serving as a key reference for oncologists in making evidence-based treatment decisions.
Within the guidelines, M-PHP is recognized as a recommended regional therapy option for patients with liver-dominant metastatic uveal melanoma. This endorsement reflects a thorough evaluation of available clinical data and positions CHEMOSAT alongside other established treatment modalities.
Notably, M-PHP is listed prominently among regional treatment options, particularly for patients with multifocal liver-only metastases. The therapy can be used either as a standalone treatment or in combination with systemic therapies, depending on individual patient characteristics.
Strong Clinical Evidence Supporting M-PHP
The guideline’s recommendation is supported by data from two Phase 3 clinical trials (NCT02678572 and NCT00324727). These studies demonstrated that M-PHP provides meaningful improvements in several critical outcomes, including:
- Hepatic progression-free survival
- Overall progression-free survival
- Overall response rates
Compared with best alternative care, patients treated with M-PHP experienced better disease control within the liver, highlighting the therapy’s effectiveness in targeting the primary site of metastasis.
Additionally, the therapy received an ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) score of 3, indicating a moderate but clinically meaningful benefit. This score applies to patients with:
- Unresectable liver metastases affecting less than 50% of the liver
- No extrahepatic disease or only limited extrahepatic disease that can be treated locally
Alignment with NCCN Guidelines and FDA Approval
M-PHP’s inclusion in the ESMO–EURACAN guidelines further strengthens its position as a globally recognized treatment option. The therapy is already featured in the Clinical Practice Guidelines of the National Comprehensive Cancer Network (NCCN), where it is recommended for metastatic uveal melanoma.
Specifically, Delcath’s HEPZATO KIT™—a commercial version of the therapy—has been classified as a Category 2A recommended treatment option for patients with hepatic-dominant disease. Importantly, M-PHP had been included in NCCN guidelines even before the U.S. Food and Drug Administration granted approval to HEPZATO KIT in 2023, underscoring the therapy’s long-standing clinical relevance.
Role in Personalized Treatment Strategies
The updated ESMO–EURACAN guidelines emphasize a multidisciplinary approach to managing metastatic uveal melanoma. In this context, M-PHP plays a critical role as part of a broader treatment strategy that may include systemic therapies such as:
- Tebentafusp (for HLA-A*02:01-positive patients)
- Anti-PD-1 immunotherapy
The guidelines highlight the flexibility of M-PHP, noting that it may be suitable for:
- Patients who are HLA-A*02:01-positive and have progressed after systemic therapy
- Patients who are HLA-A*02:01-negative
- Patients who are not candidates for systemic treatments
This adaptability makes CHEMOSAT an important tool in tailoring treatment plans to individual patient profiles.
Expanding Options for Patients with Limited Alternatives
One of the most significant implications of this guideline inclusion is the expansion of treatment options for patients with limited therapeutic choices. For individuals with liver-dominant metastatic disease, traditional systemic therapies often fail to adequately control tumor progression within the liver.
By directly targeting the liver, M-PHP addresses this unmet need and provides a viable alternative for patients who may not respond to or tolerate other treatments.
Leadership Perspective
Gerard Michel, Chief Executive Officer of Delcath Systems, emphasized the importance of this milestone, describing it as a strong validation of the company’s technology and its clinical impact.
According to Michel, the inclusion of CHEMOSAT in the ESMO–EURACAN guidelines reinforces the therapy’s role in multidisciplinary cancer care and highlights the benefits observed in both clinical trials and real-world settings. He also noted that the recognition supports the growing adoption of liver-directed therapies in managing metastatic uveal melanoma.
Future Outlook
The recognition of CHEMOSAT in major clinical guidelines signals continued momentum for Delcath Systems and its innovative approach to cancer treatment. As more clinicians adopt liver-directed therapies and additional data emerges, the role of M-PHP is likely to expand further.
Ongoing research and real-world evidence will continue to shape how the therapy is integrated into treatment algorithms, potentially leading to improved outcomes for patients with this challenging disease.
The inclusion of CHEMOSAT’s M-PHP therapy in the ESMO–EURACAN Clinical Practice Guidelines represents a significant step forward in the treatment of metastatic uveal melanoma. Backed by strong clinical evidence and aligned with existing NCCN recommendations, the therapy offers a valuable option for patients with liver-dominant disease.
As the oncology community continues to prioritize personalized and targeted treatment approaches, innovations like CHEMOSAT are playing an increasingly important role in improving patient care and expanding therapeutic possibilities
About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
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™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.
In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. 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. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.
