Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced that its proprietary CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026).
M-PHP is also recognized in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT™ (also referred to as melphalan/HDS), is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma (mUM). M-PHP has been listed as a liver-directed therapy option in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT.
The ESMO-EURACAN guideline recognizes M-PHP under regional treatments for patients with liver-dominant mUM. Two Phase 3 trials of M-PHP (NCT02678572 and NCT00324727) are cited as key supporting data, demonstrating improved hepatic and overall progression-free survival, and overall response rates compared with best alternative care. The guideline also assigns an ESMO-Magnitude of Clinical Benefit Scale score of 3 to M-PHP in the supplementary materials, for patients with unresectable hepatic metastases affecting <50% of the liver and no extrahepatic disease or limited extrahepatic disease amenable to local therapy.
M-PHP is listed first among regional treatment options for patients with multifocal liver-only metastases, either as monotherapy or in combination with systemic treatments, based on HLA-A*02:01 status. In addition, the guideline notes that the M-PHP may be an option in HLA-A*02:01-positive cases (e.g., following tebentafusp or when systemic options are not suitable), as well as HLA-A*02:01-negative cases or those not candidates for other systemic therapies. The ESMO–EURACAN guidelines emphasize a multidisciplinary approach for mUM and position liver-directed therapies such as M-PHP alongside systemic options including tebentafusp and anti-PD-1 immunotherapy in the treatment algorithm for metastatic disease.