Melblez Kit (melphalan hepatic delivery system) / Delcath, Medac - LARVOL DELTA

DELUMA: An Open‑Label, Randomized Phase II Study of Melphalan/HDS Induction Followed by Standard Therapy vs Standard Therapy Alone in Patients with Liver‑Dominant Metastatic Breast Cancer (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor

DEL-LIVER: An open-label, randomized phase II study of melphalan/HDS induction followed by standard therapy vs standard therapy alone in patients with liver-dominant refractory metastatic colorectal cancer (ESMO-GI 2026) - P2 | "Mandatory previous treatments include fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, anti-VEGF biological therapy, and/or anti-EGFR therapy if RAS wild-type...Arm A (n=60): treatment with two cycles of Melphalan/Hepatic Delivery System (HDS), followed by trifluridine-tipiracil plus bevacizumab...Clinical trial information: NCT06607458. This study is funded by Delcath, Inc."

Clinical • IO biomarker • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Anesthetic Management of Atrial Fibrillation with Rapid Ventricular Rate and Difficulty Ventilating During Hepzato Procedure (ASA 2026) - "The Hepzato Kit is a novel venous-venous bypass that isolates hepatic circulation and delivers chemotherapy to the liver only, avoiding systemic toxicity. During his second melphalan treatment while intubated under general anesthesia during the Hepzato procedure, he experienced intraoperative atrial fibrillation with RVR, low tidal volumes, and high peak pressure with progression to hypoxia. Numerous interventions were attempted, with notably improved ventilation after deflating the top Hepzato IVC balloon."

Atrial Fibrillation • Cardiovascular • Choroidal Melanomas • Melanoma • Ocular Melanoma • Solid Tumor

Delcath Systems Announces First Patient Dosed in Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Breast Cancer (Businesswire) - "The Phase 2 trial (DELUMA; NCT06875128) will evaluate the safety and efficacy of HEPZATO in combination with standard of care (SOC) versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial, which is expected to be conducted at more than 20 sites across the United States and Europe."

Trial status • HER2 Negative Breast Cancer

Case report: intrathecal chemotherapy to achieve remission in relapsed/ refractory CNS germ cell tumors (ISPNO 2026) - "Achieving disease remission prior to HDSCT is often considered a key determinant of outcome, however can be very challenging in heavily pretreated patients.[1] [2] We present the case of a 19-year-old male with multiply recurrent CNS GCT, who progressed despite multiple lines of prior platinum-based chemotherapy, two courses of CSI, and targeted therapy with imatinib and sotorasib...Given the extensive disease burden, intrathecal (IT) methotrexate, cytarabine, and hydrocortisone (MAH) was incorporated into the reinduction regimen, in addition to systemic chemotherapy...He then proceeded to tandem carboplatin-thiotepa-etoposide and cyclophosphamide-melphalan HDSCTs, followed by consolidative re-irradiation with a third course of CSI and boosts to areas of intracranial leptomeningeal disease...However, given the high risk of additive neurotoxicity, the intensification of CNS-directed therapy in heavily pretreated patients should be undertaken with caution. The role for IT..."

Case report • Clinical • CNS Tumor • Germ Cell Tumors • Oncology • Solid Tumor • AFP

Evolution of the therapeutic landscape in metastatic uveal melanoma: A single-institution real-world analysis of treatment efficacy and patient survival. (ASCO 2026) - "Clinical management relies on extrapolation of data from cutaneous melanoma with immune checkpoint inhibitors (ICI), recently approved bispecific agents such as tebentafusp for HLA A02:01 positive patients, and liver directed Hepzato Kit (whole liver perfusion of high dose melphalan). ICI had limited efficacy in UM. Tebentafusp and anti-VEGF showed evidence of activity. Combination of immunotherapy with Hepzato whole liver perfusion shows promise that warrants further investigation."

Clinical • Metastases • Real-world • Real-world evidence • Cutaneous Melanoma • Eye Cancer • Melanoma • Solid Tumor • Uveal Melanoma

Phase 2 sequential treatment of percutaneous hepatic perfusion with melphalan/hepatic delivery system followed by tebentafusp in the treatment of metastatic uveal melanoma. (ASCO 2026) - P2 | "Combining PHP with nivolumab plus ipilimumab in the randomized phase 2 CHOPIN trial significantly improved overall response (ORR), progression-free survival (PFS) and overall survival (OS) compared to PHP alone, but with significantly higher grade 3 or greater adverse events. This study opened for enrollment in November 2025, and two patients have been treated to date (NCT07276386). This study is supported by Delcath Systems, Inc."

Metastases • P2 data • Eye Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Melanoma • Solid Tumor • Uveal Melanoma • HLA-A

Delcath Systems Announces Two ASCO 2026 Investigator Initiated Trials-in-Progress Abstracts (Businesswire) - "The abstract on sequential PHP followed by tebentafusp in mUM (Abstract TPS9605) and the abstract on PHP plus nivolumab/relatlimab in metastatic melanoma with liver metastasis (Abstract TPS9600) will be presented as posters at the 2026 ASCO Annual Meeting."

Trial status • Melanoma • Uveal Melanoma

Immunoembolization in liver-predominant metastatic uveal melanoma: a single-center retrospective analysis. (PubMed, Front Oncol) - "We present a single-center retrospective analysis of IE in hepatic mUM and compare outcomes with those reported in the Phase 3 FOCUS trial evaluating melphalan via percutaneous hepatic perfusion...These findings support IE as a viable liver-directed therapy for liver-dominant mUM. Prospective, multicenter trials are warranted to clarify optimal sequencing strategies and enhance therapeutic outcomes."

Journal • Retrospective data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Delcath Systems Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Delcath Systems, Inc…announced that its CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion has been included in the newly published ESMO-EURACAN Clinical Practice Guideline for uveal melanoma, released in April 2026 (Investing.com) - "The guideline lists M-PHP as a recommended regional treatment option for patients with liver-dominant metastatic uveal melanoma....Two Phase 3 trials are cited as supporting data, showing improved hepatic and overall progression-free survival and overall response rates compared with best alternative care."

Clinical guideline

PHP-MBC-202: Randomized Study to Evaluate Melphalan/HDS Treatment Followed by Treatment with Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients with Metastatic Breast Cancer (clinicaltrialsregister.eu) - P1/2 | N=12 | Not yet recruiting | Sponsor: Delcath Systems Inc.

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Delcath Systems Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2025 ➔ Jan 2026

Enrollment open • Trial initiation date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: University of Wisconsin, Madison | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor • BRAF

Subgroup analyses of the phase 3 FOCUS study of melphalan/hepatic delivery system in patients with unresectable metastatic uveal melanoma. (PubMed, J Cancer Res Clin Oncol) - "Results demonstrate a favorable benefit-risk profile for melphalan/HDS across clinically relevant subgroups. However, early treatment in patients with low tumor burden may offer best results."

Journal • P3 data • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (clinicaltrials.gov) - P1/2 | N=15 | Not yet recruiting | Sponsor: University of Wisconsin, Madison

New P1/2 trial • Melanoma • Oncology • Solid Tumor

Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute

New P2 trial • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Delcath Systems Announces Publication of Expert Narrative Review on Percutaneous Hepatic Perfusion for Liver Metastases from Uveal Melanoma (Yahoo Finance) - "The narrative review synthesizes data from prospective and retrospective studies from leading centers in the US and Europe, collectively demonstrating objective response rates of 36%-72%, median overall survival of 15-20 months, and disease control rates up to 89%. Key highlights include: PHP’s suitability for multifocal, bilobar UM liver metastases, delivering high-dose chemotherapy with extracorporeal filtration to minimize systemic toxicity."

Clinical data • Uveal Melanoma

Treatment of Liver Metastases from Uveal Melanoma with Percutaneous Hepatic Perfusion. (PubMed, J Vasc Interv Radiol) - "Percutaneous hepatic perfusion (PHP) with melphalan, now FDA-approved via the Hepzato Kit, delivers high-dose chemotherapy directly to the liver while reducing systemic toxicity through extracorporeal filtration. Clinical data show encouraging survival and disease control with manageable hematologic toxicity and rapid recovery. Research into improved filtration, optimized dosing, and immunotherapy integration may further improve outcomes."

Journal • Review • Anesthesia • Eye Cancer • Hematological Disorders • Hepatology • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

2025 Full Year Financial Guidance (Businesswire) - "Total CHEMOSAT and HEPZATO KIT revenue of $83 million to $85 million, reflecting an approximate 150% increase in treatment volume over 2024"

Commercial • Uveal Melanoma

Delcath Systems…announced the results of the CHOPIN randomized Phase 2 clinical trial (CHOPIN Trial) presented…at the 2025 European Society of Medical Oncology (ESMO) Annual Congress (Businesswire) - "CHOPIN clinical trial meets primary endpoint....Progression-Free Survival (95% CI): (i) One Year % (95% CI); Combination group: 54.7% (36.8 - 69.5); PHP group: 15.8% (5.8 - 30.1); (ii) Median months (95% CI): Combination group: 12.8 (9.2 - 15.4); PHP group: 8.3 (6.0 - 9.6)....Overall Survival - (95% CI): (i) One Year % (95% CI): Combination group: 82.8% (65.6 - 91.9); PHP group: 82.2% (64.5 - 91.6); (ii) Two Year % (95% CI): Combination group: 49.6% (29.3 - 67.0); PHP group: 22.1% (7.9 - 40.6)."

P2 data • Uveal Melanoma

Percutaneous Hepatic Perfusion Melphalan Induced Sinusoidal Obstruction Syndrome (Veno-Occlusive Disease) in a Patient with Metastatic Uveal Melanoma. (PubMed, Case Rep Oncol) - "Percutaneous hepatic perfusion using the HEPZATO KIT™ (Delcath Systems, Inc., Queensbury, NY) is a US Food and Drug Administration approved treatment for liver metastases from uveal melanoma...He was treated with defibrotide and symptoms resolved, but passed away several months later due to progression in metastatic disease. To our knowledge, this represents the first case of sinusoidal obstruction syndrome after melphalan administration for percutaneous hepatic perfusion. Rapid progression of disease versus sinusoidal obstruction disease must be considered in patients who present with signs of liver injury/failure after this procedure as prompt diagnosis and treatment are crucial."

Journal • Eye Cancer • Hepatocellular Cancer • Hepatology • Liver Failure • Melanoma • Oncology • Otorhinolaryngology • Solid Tumor • Uveal Melanoma

Delcath Systems Announces Investigator-Initiated CHOPIN Phase 2 Trial Presentation at ESMO 2025 Congress (Businesswire) - "Principal Investigator Ellen Kapiteijn...will present data evaluating the safety, tolerability, and efficacy of sequencing systemic ipilimumab and nivolumab with Delcath’s CHEMOSAT Hepatic Delivery System for percutaneous hepatic perfusion with melphalan in patients with metastatic uveal melanoma."

P2 data • Uveal Melanoma

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Delcath Systems Inc. | Not yet recruiting ➔ Recruiting | Initiation date: May 2025 ➔ Aug 2025

Enrollment open • Trial initiation date • Colorectal Cancer • Oncology • Solid Tumor

Delcath Systems Announces First Patient Dosed in Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Colorectal Cancer (Businesswire) - "Approximately 90 patients will be enrolled in this randomized, controlled trial....Results from the trial’s primary endpoint, hepatic progression-free survival (hPFS), are anticipated by mid-2028, while overall survival (OS), a secondary endpoint, is expected in late 2028."

P2 data • Trial status • Colorectal Cancer