Medarex, BMS Announce Results of Phase I/II Study of MDX-010, IL-2

Medarex and Bristol-Myers Squibb have announced results of an early clinical study with the investigational fully human anti-CTLA-4 antibody, MDX-010, in which eight of 36 patients with metastatic melanoma experienced objective clinical responses (three complete responses and five partial responses).

In the Phase I/II clinical trial, patients received MDX-010 every three weeks, with three patients per dose level at 0.1, 0.3, 1 and 2 mg/kg. Twenty-four patients received 3 mg/kg of MDX-010. In addition to receiving antibody, all patients received high-dose IL-2 therapy. Of the eight patients who experienced objective tumor regression, two patients in the 3 mg/kg cohort experienced complete responses that are ongoing at more than 13 months, and one patient in the 2 mg/kg cohort experienced a complete response that is ongoing at more than 16 months.

Five patients experienced partial responses, with responses ranging from seven months to the longest duration ongoing at more than 19 months. Five patients in the clinical study reported Grade III/IV adverse events, including colitis and uveitis, that were consistent with the immune-based mechanism of action, as well as pancreatitis, arthritis and laryngospasm.