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

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

Response to Letter to the Editor Regarding: An Open-Label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma. (PubMed, Ann Surg Oncol) - No abstract available

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

An Open-Label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma. (PubMed, Ann Surg Oncol) - No abstract available

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

ASO Visual Abstract: An Open-Label, Randomized Study of Melphalan/Hepatic Delivery System versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma. (PubMed, Ann Surg Oncol) - No abstract available

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

ASO Author Reflections: Percutaneous Hepatic Perfusion with Melphalan/Hepatic Delivery System Versus Best Alternative Care for Patients with Metastatic Uveal Melanoma. (PubMed, Ann Surg Oncol) - No abstract available

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

Real world experience of melphalan/hepatic delivery system with circulating tumor DNA (ctDNA) monitoring in patients with metastatic uveal melanoma. (ASCO 2025) - "Melphalan/HDS is a novel treatment option for patients with unresectable mUM. In our real-world study, we observed good tolerability and encouraging efficacy. We did not observe any new safety signals."

Circulating tumor DNA • Clinical • Metastases • Real-world • Real-world evidence • Anemia • Eye Cancer • Fatigue • Hematological Disorders • Hepatology • Liver Cancer • Melanoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Uveal Melanoma • HLA-A

Immunoembolization in liver-predominant metastatic uveal melanoma: A single-center retrospective analysis. (ASCO 2025) - "Metastatic UM (mUM) literature is limited (due to its rarity/complexity) and management remains challenging, as standard therapies—liver-directed approaches (e.g. transarterial chemoembolization [TACE]) and systemic therapy with tebentafusp (limited to HLA-A*02:01-positivity)—offer limited efficacy, with no durable responses or significant survival benefits. We highlight IE's comparable efficacy to Delcath's melphalan/Hepatic Delivery System regarding mUM PFS and OS, with added benefits for previously treated patients. While our findings advance understanding of mUM management, more prospective studies are needed to improve therapeutic strategies/patient outcomes."

Metastases • Retrospective data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • HLA-A

Melphalan/HDS treatment for patients with hepatic dominant metastatic uveal melanoma: Results from an expanded access program. (ASCO 2025) - P3 | "Treatment with Melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM. Toxicities were manageable and overall treatment with Melphalan/HDS was well tolerated. Best Overall Response"

Clinical • Metastases • Cardiovascular • Eye Cancer • Febrile Neutropenia • Hematological Disorders • Hepatocellular Cancer • Melanoma • Neutropenia • Oncology • Respiratory Diseases • Solid Tumor • Thrombocytopenia • Uveal Melanoma • Ventricular Tachycardia

Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Breast Cancer (Businesswire) - "Delcath Systems, Inc...announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC). With the FDA's review complete, Delcath is now cleared to initiate patient enrollment in the U.S....The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the fourth quarter of 2025. The trial’s primary endpoint, hepatic progression-free survival, is anticipated to be announced by the end of 2028, while results for overall survival, a secondary endpoint, are expected in 2029."

IND • New P2 trial • Breast Cancer

New liver directed treatment improves outcomes for rare eye cancer (News-Medical) - P3 | N=102 | FOCUS (NCT02678572) | Sponsor: Delcath Systems Inc. | "A multi-institutional study led by Moffitt Cancer Center found that percutaneous hepatic perfusion using a melphalan hepatic delivery system may help patients with a rare eye cancer that has spread to their liver...One group of patients received the melphalan hepatic delivery system treatment, while the other group received standard of care treatment. Patients treated with the melphalan hepatic delivery system experienced significantly improved outcomes than those receiving alternative care. The median progression-free survival for these patients was 9.1 months, compared with 3.3 months for those on standard treatments...The objective response rate was 27.5%, nearly three times the 9.4% observed in the comparison group. The disease control rate also substantially increased from 46.9% to 80.0%. Patients treated with the melphalan hepatic delivery system lived a median of 18.5 months, compared with...

P3 data • Uveal Melanoma

An Open-label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma. (PubMed, Ann Surg Oncol) - "Treatment with Melphalan/HDS shows clinically meaningful efficacy and demonstrates a favorable benefit-risk profile in patients with unresectable mUM as compared to BAC."

Journal • Eye Cancer • Febrile Neutropenia • Gastroenterology • Hematological Disorders • Hepatology • Leukopenia • Melanoma • Neutropenia • Ocular Melanoma • Oncology • Solid Tumor • Thrombocytopenia • 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 | Not yet recruiting | Sponsor: Delcath Systems Inc.

New P2 trial • Breast Cancer • Hepatology • Oncology • Solid Tumor

Delcath Systems Reports Fourth Quarter and Full Year 2024 Results (Businesswire) - "Total fourth quarter and full year revenue of $15.1 million and $37.2 million, respectively: HEPZATO KIT fourth quarter and full year revenue of $13.7 million and $32.3 million, respectively; CHEMOSAT fourth quarter and full year revenue of $1.4 million and $4.9 million, respectively....Total revenue for the year-ended December 31, 2024 was $37.2 million compared to $2.1 million for the same period in the prior year. Revenue in 2024 includes sales of $32.3 million of HEPZATO in the U.S. and $4.9 million of CHEMOSAT in Europe."

Sales • Colorectal Cancer • Uveal Melanoma

Updated NCCN Guidelines Recommend HEPZATO KIT for Hepatic-Dominant Uveal Melanoma (OncLive) - "The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for the treatment of metastatic uveal melanoma to include HEPZATO KIT ([melphalan] for Injection/Hepatic Delivery System [HDS]) as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma...A subgroup analysis from the pivotal phase 3 FOCUS trial (NCT02678572) showed no significant differences in objective response rate (ORR), progression-free survival (PFS), or overall survival (OS) between patients with and without extrahepatic metastatic uveal melanoma who were treated with melphalan/HDS."

NCCN guideline • Uveal Melanoma

Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma (Businesswire) - "Delcath Systems...today announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of metastatic uveal melanoma (mUM). Our 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....The updated NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma. Previously, the guidelines limited its use to patients with metastases confined to the liver. This revision aligns with the HEPZATO KIT label."

NCCN guideline • Uveal Melanoma

Delcath Systems Announces Additional $16.3 Million in Funding From Series E and E1 Warrant Exercises (Businesswire) - "'With the exercise of these warrants, current cash on hand and cash expected from operations as a result of our revenue growth, we believe that we are in a strong position to execute on our ongoing commercialization efforts and our robust clinical development plan.'....'As we continue to drive the commercial success of HEPZATO to treat uveal melanoma patients we can confidently invest in new clinical trials.'"

Financing • Uveal Melanoma

Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Colorectal Cancer (Businesswire) - "Delcath Systems...announced that the...FDA has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) for liver-dominant metastatic colorectal cancer....The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the second half of 2025. The trial’s primary endpoint, hepatic progression-free survival (hPFS), is anticipated to read out by the end of 2027, while overall survival (OS), a secondary endpoint, is expected in 2028."

IND • New P2 trial • Colorectal Cancer