Delcath Systems Advances HEPZATO Trials with Two ASCO 2026 Abstracts
Event summary
- Delcath Systems announced two investigator-initiated trials-in-progress abstracts for the 2026 ASCO Annual Meeting, focusing on HEPZATO KIT for metastatic melanoma involving the liver.
- One Phase 2 trial evaluates sequential treatment with HEPZATO followed by tebentafusp in metastatic uveal melanoma, enrolling since November 2025.
- A second Phase 1b/2 study assesses HEPZATO in combination with nivolumab/relatlimab as a first-line treatment for metastatic non-uveal melanoma with liver involvement, enrolling since January 2026.
- Both abstracts will be presented as posters at the 2026 ASCO Annual Meeting in Chicago.
The big picture
Delcath Systems is positioning HEPZATO KIT as a key player in the treatment of liver metastases from melanoma, a challenging and underserved area in oncology. The company's focus on investigator-initiated trials underscores the growing clinical interest in liver-directed therapies combined with modern systemic treatments. These trials could potentially broaden the market for HEPZATO KIT, especially if they demonstrate improved outcomes in metastatic melanoma patients with liver involvement.
What we're watching
- Clinical Efficacy
- How the sequential treatment with HEPZATO and tebentafusp will impact progression-free survival and overall survival in metastatic uveal melanoma.
- Combination Therapies
- Whether the combination of HEPZATO with nivolumab/relatlimab can establish a new first-line treatment approach for metastatic non-uveal melanoma with liver involvement.
- Regulatory Pathway
- The pace at which Delcath can leverage these trial results to expand the approved indications for HEPZATO KIT in the U.S. and CHEMOSAT in Europe.
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