Cancer specialists can treat many types of cancer, including metastatic uveal melanoma, with medications that kill fast-growing cells in your body called chemotherapies. While chemotherapies are not often used in the treatment of cutaneous melanoma, they are re-emerging as a potential tool in the treatment of uveal melanoma. Liver-directed melphalan (Hepzato Kit) can help patients with metastatic uveal melanoma live longer by shrinking melanoma tumors that have spread to the liver.
Hepzato Kit is a novel therapy that delivers melphalan, a well-studied chemotherapy drug first approved in 1964, directly to the liver through a novel delivery system called the Hepatic Delivery System (HDS). This allows oncologists to treat metastatic uveal melanoma liver tumors with much higher doses of melphalan than would otherwise be possible. By administering the therapy only to the liver, systemic side effects are significantly reduced.
Hepzato Kit was approved based on results from Delcath's Phase 3 FOCUS clinical trial. In this single arm, multicenter study, 91 patients with metastatic uveal melanoma with unresectable (ineligible for surgery) liver metastases received Hepzato Kit every 6 to 8 weeks, for up to 6 treatments. Together, these patients had an objective response rate (ORR) – meaning the percentage of patients that had a significant reduction in size or disappearance of their tumor – of 36.3% and a median duration of response (DoR) of 14 months. The Disease Control Rate (DCR) – meaning the percentage of patients whose tumors either shrink or remain stable – among the patient cohort was 73.6% and included 7 complete responses (7.7%) and 26 partial response (28.6%).1
The study enrolled patients with metastatic uveal melanoma with metastases predominately involving the liver (liver dominant). Patients with limited metastases beyond the liver, such as in the bone, subcutaneous sites, lymph nodes, or lung were permitted if the life-threatening component of the uveal melanoma was in the liver and the tumors outside the liver had a defined treatment plan. Fifty six percent of patients in the cohort had not received any previous systemic treatment for their melanoma.
Patients with Metastatic Uveal Melanoma that has Metastasized to the Liver:
In 2023, the U.S. Food and Drug Administration (FDA) approved liver-directed melphalan (Hepzato Kit) for the treatment of:
Speak to your doctor to see if you are eligible to be treated with liver-directed melphalan (Hepzato Kit).
Patients receive liver-directed melphalan (Hepzato Kit) directly into the hepatic artery (the main source of blood to the liver) through a minimally invasive procedure known as percutaneous hepatic perfusion (PHP). During this procedure, the liver is temporarily isolated from the body’s circulatory system during which melphalan is infused directly to the liver over a 30-minute period. Upon exiting the liver, the patient’s blood is filtered before returning it to systemic circulation.
Treatments are administered in a hospital setting at select sites every six to eight weeks.
The goals of using liver-directed melphalan (Hepzato Kit) include:
All melanoma treatments, including liver-directed melphalan (Hepzato Kit), have side effects, which can sometimes be serious. Patients should talk with their physician to learn more about the side effects of liver-directed melphalan (Hepzato Kit) and other melanoma treatment options.
Not all treatments work for all patients, because everyone is different. If you are interested in learning more about liver-directed melphalan (Hepzato Kit), here are some questions you should ask your care team:
