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Delcath Systems Announces Two Investigator-Initiated Trial Abstracts
Delcath Systems announced the publication of two investigator-initiated trials-in-progress abstracts on May 21, 2026. These abstracts will be presented at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago. The abstracts highlight ongoing clinical investigations evaluating the use of Delcath's percutaneous hepatic perfusion with melphalan using the HEPZATO KIT(TM) Hepatic Delivery System in metastatic melanoma involving the liver - a common and difficult-to-treat site of disease progression. One abstract, titled "Phase 2 sequential treatment of percutaneous hepatic perfusion with melphalan/hepatic delivery system followed by tebentafusp in the treatment of metastatic uveal melanoma," describes an investigator-initiated Phase 2 trial evaluating sequential treatment with HEPZATO followed by tebentafusp in patients with metastatic uveal melanoma (mUM) who are HLA-A*02:01 positive and have isolated or liver-dominant metastases. The study is designed to assess progression-free survival and additional measures including safety, objective response, overall survival, and biomarker analyses. The study opened for enrollment in November 2025. A second abstract, titled "Phase 1b/2 trial of melphalan-percutaneous hepatic perfusion (PHP) therapy and nivolumab/relatlimab in patients with metastatic melanoma and liver metastasis," outlines a single-center Phase 1b/2 study evaluating HEPZATO in combination with nivolumab/relatlimab as a first-line treatment approach for patients with metastatic non-uveal melanoma involving the liver. The trial is intended to assess safety, tolerability, and preliminary efficacy, with secondary objectives including disease control rate, progression-free survival, overall survival, duration of response, and tumor reduction. The study opened for enrollment in January 2026.
Company Confirms FY26 Gross Margin View at 84%-87%
Backs FY26 gross margin view 84%-87%.
HEPZATO KIT Reports Q1 Revenue of $25M
Reports Q1 revenue $25M, consensus $23.41M. "We delivered a strong first quarter, marked by 20% volume growth over the prior quarter and a strong increase in new patient starts," said Gerard Michel, Chief Executive Officer. "The recent publication of the full CHOPIN results in The Lancet Oncology is already having a meaningful impact on prescribing patterns, further validating HEPZATO KIT and positioning us for continued momentum and long-term value for patients and shareholders alike."
Delcath Systems Presents New Data Supporting HEPZATO KIT
Delcath Systems announced that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan using the CHEMOSAT Hepatic Delivery System was presented today at the ESMO Breast Cancer Congress 2026. Patient population: Fifteen patients were treated between September 2015 and May 2024 after a median of 4 prior systemic therapy lines (range 1-6). Treatment delivery: Patients received a median of 1 M-PHP cycle (range 1-7), typically followed by ICU admission of 1-2 days. Safety: 67% of patients required blood transfusions (primarily packed red blood cells). Intra-/peri-procedural adverse events occurred in 60% of patients (primarily hematologic or hemodynamic). Grade 3-4 post-procedure adverse events occurred in 80% of patients, predominantly bone marrow suppression with neutropenic-related infections; events typically onset early (median 1 day) and resolved in a median of 7 days. Liver response: Hepatic partial response was observed in 9 of 15 treated patients (60%); 3 patients were not evaluable for response. Overall survival: Median overall survival from first M-PHP was 6.0 months (95% CI, 2.9-NR; range 0.1-76.5); 33% (5/15) of patients were alive at last follow-up. Median follow-up was 55.6 months (95% CI, 53.7-NR). "These data from independent European investigators represent real-world evidence supporting the use of HEPZATO KIT and CHEMOSAT in liver-dominant metastatic breast cancer and underscore the need for further evaluation in this heavily pretreated population," said Gerard Michel, Chief Executive Officer of Delcath Systems.
Delcath Systems' M-PHP Included in New Guidelines
Delcath Systems announced that its proprietary CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion 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. M-PHP is also recognized in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma. 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.
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