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Sep 17, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Imetelstat: Phase II data

Geron discontinued an open-label Phase II trial in 166 patients with locally recurrent or metastatic HER2-negative breast cancer after an unplanned interim analysis showed that median PFS, the primary endpoint, was significantly shorter in patients receiving imetelstat plus paclitaxel vs. paclitaxel alone (6.2 vs. 8 months, p=0.028). At the time of the interim analysis, 85 progression events had occurred, or 91% of the pre-specified 93 events required for the primary endpoint analysis. Geron's internal safety monitoring committee conducted the interim analysis after it reported a greater number of deaths and patients discontinuing paclitaxel in the imetelstat arm vs. the control arm. There were 16 deaths in the imetelstat plus paclitaxel arm and 10 deaths in the paclitaxel alone arm, although there was no significant difference in OS between...

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