Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma
Delcath Systems (DCTH) announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for treating metastatic uveal melanoma (mUM). The NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma, expanding from its previous limitation to patients with metastases confined to the liver.
This update aligns with HEPZATO KIT's label and is particularly significant as over 90% of mUM patients develop liver metastases. A Phase 3 FOCUS trial subgroup analysis showed no significant differences in objective response rate, progression-free survival, or overall survival between patients with and without extrahepatic disease. HEPZATO KIT and CHEMOSAT are designed to administer high-dose chemotherapy to the liver.
Delcath Systems (DCTH) ha annunciato un aggiornamento alle Linee Guida Cliniche della National Comprehensive Cancer Network (NCCN) per il trattamento del melanoma uveale metastatico (mUM). Le linee guida NCCN ora includono HEPZATO KIT come opzione terapeutica di Categoria 2A per i pazienti con melanoma uveale a predominanza epatica, ampliando la precedente limitazione ai pazienti con metastasi confinate al fegato.
Questo aggiornamento è in linea con l'etichetta di HEPZATO KIT ed è particolarmente significativo poiché oltre il 90% dei pazienti con mUM sviluppa metastasi epatiche. Un'analisi del sottogruppo dello studio FOCUS di Fase 3 ha mostrato che non ci sono differenze significative nel tasso di risposta obiettiva, nella sopravvivenza libera da progressione o nella sopravvivenza complessiva tra i pazienti con e senza malattia extraepatica. HEPZATO KIT e CHEMOSAT sono progettati per somministrare chemioterapia ad alta dose al fegato.
Delcath Systems (DCTH) anunció una actualización de las Guías de Práctica Clínica de la National Comprehensive Cancer Network (NCCN) para el tratamiento del melanoma uveal metastásico (mUM). Las Guías de NCCN ahora incluyen HEPZATO KIT como una opción de tratamiento de Categoría 2A para pacientes con melanoma uveal de predominancia hepática, ampliando la limitación anterior a pacientes con metástasis confinadas al hígado.
Esta actualización está alineada con la etiqueta de HEPZATO KIT y es particularmente significativa, ya que más del 90% de los pacientes con mUM desarrollan metástasis hepáticas. Un análisis de subgrupo del ensayo FOCUS de Fase 3 no mostró diferencias significativas en la tasa de respuesta objetiva, la supervivencia libre de progresión o la supervivencia general entre pacientes con y sin enfermedad extrahepática. HEPZATO KIT y CHEMOSAT están diseñados para administrar quimioterapia de alta dosis al hígado.
Delcath Systems (DCTH)는 전이성 맥락막 흑색종(mUM) 치료를 위한 국가 종합 암 네트워크(NCCN) 임상 진료 지침 업데이트를 발표했습니다. NCCN 지침에는 이제 간 우세 맥락막 흑색종 환자를 위한 2A 범주의 치료 옵션으로 HEPZATO KIT가 포함되어 있으며, 이전에는 간에 국한된 전이 환자만 포함되었습니다.
이번 업데이트는 HEPZATO KIT의 라벨과 일치하며, mUM 환자의 90% 이상이 간 전이를 개발하는 점에서 특히 중요합니다. FOCUS 3상 시험의 하위 분석에서는 간외 질환이 있는 환자와 없는 환자 간에 객관적 반응률, 무진행 생존 기간 또는 전체 생존 기간에서 유의미한 차이가 없음을 보여주었습니다. HEPZATO KIT 및 CHEMOSAT는 간에 고용량 화학요법을 투여하도록 설계되었습니다.
Delcath Systems (DCTH) a annoncé une mise à jour des Directives de Pratique Clinique du National Comprehensive Cancer Network (NCCN) pour le traitement du mélanome uvéal métastatique (mUM). Les Directives NCCN incluent désormais HEPZATO KIT comme option de traitement de Catégorie 2A pour les patients atteints de mélanome uvéal à prédominance hépatique, élargissant ainsi la limitation précédente aux patients avec des métastases confinées au foie.
Cette mise à jour est en accord avec l'étiquette de HEPZATO KIT et est particulièrement significative, car plus de 90 % des patients atteints de mUM développent des métastases hépatiques. Une analyse de sous-groupe de l'essai FOCUS de Phase 3 n'a montré aucune différence significative dans le taux de réponse objective, la survie sans progression ou la survie globale entre les patients avec et sans maladie extra-hépatique. HEPZATO KIT et CHEMOSAT sont conçus pour administrer une chimiothérapie à forte dose au foie.
Delcath Systems (DCTH) hat ein Update zu den klinischen Praxisleitlinien der National Comprehensive Cancer Network (NCCN) für die Behandlung von metastasiertem uvealem Melanom (mUM) angekündigt. Die NCCN-Leitlinien beinhalten jetzt HEPZATO KIT als Behandlungsoption der Kategorie 2A für Patienten mit leberdominantem uvealem Melanom und erweitern damit die zuvor bestehende Einschränkung auf Patienten mit auf die Leber beschränkten Metastasen.
Dieses Update steht im Einklang mit dem Etikett von HEPZATO KIT und ist besonders bedeutend, da über 90% der mUM-Patienten Lebermetastasen entwickeln. Eine Subgruppenanalyse der Phase-3-Studie FOCUS zeigte keine signifikanten Unterschiede in der objektiven Ansprechrate, der progressionsfreien Überlebenszeit oder der Gesamtüberlebenszeit zwischen Patienten mit und ohne extrahepatische Erkrankung. HEPZATO KIT und CHEMOSAT sind darauf ausgelegt, hochdosierte Chemotherapie an die Leber zu verabreichen.
- NCCN Guidelines expanded HEPZATO KIT's recommended use to include hepatic-dominant uveal melanoma patients
- Guideline update expands the potential patient population for HEPZATO KIT treatment
- Phase 3 FOCUS trial demonstrated consistent efficacy regardless of extrahepatic disease presence
- None.
Insights
The NCCN's guideline update for HEPZATO KIT represents a pivotal development that significantly expands the product's market opportunity. The revision to include hepatic-dominant cases, rather than just liver-confined metastases, addresses a critical medical need, as over 90% of metastatic uveal melanoma patients develop liver metastases.
The Category 2A designation carries substantial weight in the oncology community for three key reasons:
- It typically facilitates broader insurance coverage and reimbursement approval
- It influences treatment decisions by oncologists and interventional radiologists
- It validates the clinical utility of HEPZATO KIT beyond its initial scope
The Phase 3 FOCUS trial data showing comparable efficacy in patients with and without extrahepatic disease provides robust clinical validation for this expanded indication. This is particularly significant as the liver is often the life-limiting organ in disease progression, making effective hepatic-targeted therapy important for patient outcomes.
From a market perspective, this update positions Delcath advantageously in the interventional oncology space. The expanded guidelines should accelerate market adoption and potentially increase utilization in major cancer centers. The timing is strategic, coming early in the commercial launch phase, which could accelerate revenue ramp-up and market penetration.
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. Given that over
“We are encouraged by the NCCN’s decision to expand HEPZATO’s recommendation in the guidelines to include patients with extrahepatic disease, recognizing the critical role hepatic progression plays in the course of metastatic uveal melanoma,” said Gerard Michel, Chief Executive Officer of Delcath. “This update underscores the growing recognition of HEPZATO as an important treatment option for patients battling this challenging disease.”
About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's 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 while controlling systemic exposure and associated side effects during a PHP procedure.
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Safe Harbor / Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company's filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
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Investor Relations:
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Source: Delcath Systems, Inc.
FAQ
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