catumaxomab (Removab®)
Appraisal information
catumaxomab (Removab®) 10 micrograms concentrate for solution for infusion
catumaxomab (Removab®) 50 micrograms concentrate for solution for infusion
Removab (catumaxomab) is now available to treat malignant ascites due to EpCAM-positive carcinomas where standard therapy is not available or not feasible.
Catumaxomab is a hybrid rat-mouse monoclonal antibody that has binding sites for the epithelial cell adhesion molecule (EpCAM) and CD3, a component of the T cell receptor. It stimulates a range of immune responses against tumour cells.
A randomised, open-label trial compared catumaxomab (as 4 intraperitoneal infusions) plus paracentesis with paracentesis alone in 258 patients with symptomatic malignant ascites due to EpCAM-positive carcinomas. Median puncture-free survival, the primary endpoint, was significantly longer with catumaxomab than with drainage alone (46 days vs 11 days; p<0.0001). Median time to the next therapeutic puncture was also significantly increased in the catumaxomab group compared with the drainage-alone group (77 days versus 13 days; p<0.0001) and there was a trend towards increased overall survival with catumaxomab (72 days vs 68 days; p=0.0846).