Preliminary Data from Ongoing Phase 1 Data of Investigational Anti-PD-1 Antibody Presented at American Society of Clinical Oncology Annu...(owfully enrolled in the expansion cohort...),Health

Date:6/2/2008

ow fully enrolled in the expansion cohort at the highest dose. Eligible patients with recurrent or treatment-refractory solid tumors (including non-small cell lung cancer, renal, colon, melanoma, and hormone-refractory prostate cancer) received single-dose treatment of 0.3, 1, 3 or 10 mg/kg of MDX-1106 and were allowed re-treatment with multiple doses. All doses were well-tolerated with no observed severe immune-related adverse events and no dose-limiting toxicities within the first four weeks following single-dose therapy. Two patients with histories of arthritis that were not disclosed to the investigator prior to enrollment in the trial (history of autoimmune disease requiring treatment is an exclusion criterion for the trial) developed low grade arthritic symptoms that responded to oral corticosteroid treatment. Of the 11 patients that were eligible for re-treatment, one patient with ocular melanoma developed colitis 3 weeks after receiving a fifth dose of 1 mg/kg (over 9 months), and is improving with medical treatment of this immune- related adverse event after discontinuation of MDX-1106 dosing. In the 21 patients who have received 10 mg/kg of MDX-1106, including 3 patients who have received at least 3 doses, no serious immune-related adverse events have been observed.

About MDX-1106/ONO-4538

MDX-1106/ONO-4538 is a novel fully human antibody designed to target and inhibit the function of PD-1 (programmed cell death 1), a receptor expressed on the surface of activated lymphocytes (T-cells) that is involved in the system of negative regulation for the suppression of activated lymphocytes. Preclinical studies suggest that blockade of the PD-1 signaling pathway by MDX-1106/ONO-4538 activates T-cell responses and promotes an immune response to fight tumors and infectious diseases. Medarex and Ono Pharmaceutical are investigating the potential of MDX-1106/ONO-4538 in ongoing Phase 1 trials for the treatment of cancer and hepatitis C.

About Meda
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