Clinical History
Battling Cancers in the Liver
According to the American Cancer Society, cancers in the liver are among the most prevalent and lethal forms of the disease. They can either be primary, originating in the liver, or metastatic, originating elsewhere and traveling to the liver, creating new tumors there. The current treatment armamentarium for cancers in the liver includes surgery, transplantation, systemic chemotherapy, a variety of focal and regional therapies, and radiation therapy, which have varying degrees of invasiveness, efficacy, and side effects.
Developing Chemosaturation Therapy
In an effort to expand treatment options for cancers in the liver, Delcath is developing a proprietary system for chemosaturation therapy. We believe this investigational, minimally invasive and repeatable procedure has the potential to complement existing therapies in the management of cancers in the liver. Years of clinical research have gone into refining this system.
Delcath’s proprietary system for chemosaturation utilizes the chemotherapeutic agent melphalan hydrochloride in a dose of 3.0 mg/kg, which was defined as the maximum tolerated dose in a phase 1 clinical trial conducted by Pinkpank, et al in patients with hepatic malignancies. This dose represents a nearly 10-fold increase over the approved systemic dose of melphalan.
A more recent phase 3 study compared Delcath’s proprietary chemosaturation system with melphalan to best alternative care (BAC) for patients with metastatic cancer in the liver caused by ocular and cutaneous melanoma. The study revealed that patients who were treated with the chemosaturation system experienced significantly improved (P<0.001) hepatic progression-free survival (hPFS) compared to patients treated in the study’s BAC arm.
Additionally, a recently completed phase 2 clinical trial evaluated the efficacy of chemosaturation therapy with melphalan in four different tumor types: primary liver cancer, metastatic neuroendocrine tumors, adenocarcinoma, and melanoma.
Chemosaturation therapy has the potential for clinically meaningful tumor reduction. Nevertheless, as with most medical procedures and cancer medications, there are certain inherent risks related to the placement of catheters and/or toxicities from systemic exposure to residual drug in the bloodstream.
