Fresenius Reports Positive Results From Study of Malignant Ascites

Fresenius has announced encouraging results in the non-ovarian-cancer patient stratum of a Phase II/III pivotal study of malignant ascites using the trifunctional antibody removab.

After positive results in the treatment of patients with ascites from ovarian cancer, the antibody again showed a clear advantage over a therapy with puncture alone. The median puncture-free survival period (the primary endpoint) in the patient group treated with removab (catumaxomab) was significantly longer compared with the control group and clinically relevant. The median puncture-free survival was 37 days in the removab group versus 14 days in the control group.

In the subgroup of patients with ascites from gastric cancer the difference was even more marked, with a median puncture-free survival of 44 days in the removab group versus 15 days in the control group. All other patients (with breast, pancreatic, colorectal and other types of cancer) had a median puncture-free survival of 30 days with removab versus nine days in the control group.

Positive results were also achieved in key secondary endpoints, such as the length of time between treatment and first therapeutic puncture (median time to the first therapeutic puncture). The median time to the first therapeutic puncture for all non-ovarian cancers was 80 days versus 15 days in the control group. Patients with gastric cancer benefited especially from the treatment. Median time to the first therapeutic puncture was 118 days in the removab group versus 15 days in the control group. For all other patients the median time to the first therapeutic puncture in the removab group was 69 days versus 15 days in the control group.

Removab demonstrated a good safety profile, according to the company. Drug-related adverse events due to cytokine release were mild to moderate and mostly fully reversible, with fever, nausea and vomiting being the most common. Pathologic increases of liver parameters and undesirable changes in white blood cell counts were also mild to moderate, transient and mostly without clinical relevance.