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Home » MICROMET, SERONO PHASE II TRIALS DO NOT MEET MAIN ENDPOINT
MICROMET, SERONO PHASE II TRIALS DO NOT MEET MAIN ENDPOINT
October 4, 2006
Micromet and Serono have reported the outcome of two Phase II trials testing the activity of adecatumumab (MT201) in metastatic breast cancer and in prostate cancer. Adecatumumab, a fully human monoclonal antibody targeting tumor cells overexpressing the epithelial cell adhesion molecule (EpCAM), was assessed as a single agent for efficacy and safety in patients with EpCAM-positive metastatic breast cancer and in patients with prostate cancer. The studies tested adecatumumab at two dose levels in patients with high and low EpCAM expression. The results suggested dose-dependent activity of adecatumumab as well as a dependency on relevant levels of target expression.
The first randomized, open-label study was conducted in five European countries at 26 centers. Patients were stratified according to EpCAM expression into two groups, one with low EpCAM expression and another with high EpCAM expression. Each group was then randomized into two arms treated every two weeks by intravenous infusion at either 2 or 6 mg adecatumumab per kilogram of body weight. Patients were treated until disease progression with full tumor assessments every six weeks according to standardized RECIST criteria.
While the primary endpoint of the study (25 percent clinical benefit rate at week 24) was not reached, secondary endpoint analysis showed a significant prolongation of time to progression in patients treated with the higher dose of adecatumumab compared with patients receiving the lower dose.
The second trial used serum PSA levels as the main readout for biological and clinical activity. The primary endpoint of this study was mean change in PSA at week 24 compared with baseline. While the primary endpoint was not reached, the analysis of the final data of the study indicated that treatment with 6 mg/kg adecatumumab had a beneficial trend when compared with placebo.
KEYWORDS Drug Pipeline Alert
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