For women treated with the combination of palbociclib plus letrozole, the median PFS was 20.2 months, a statistically significant improvement compared to the 10.2 months of PFS in women who received letrozole alone (HR=0.488 [95% CI: 0.319, 0.748]; p=0.0004) (Press release Pfizer, MAY 5, 2014, View Source [SID:1234500490]). Final results for the secondary efficacy endpoints of duration of treatment and clinical benefit rate demonstrated superiority in the palbociclib plus letrozole arm compared to the letrozole-only arm. Additionally, an initial assessment of overall survival (OS), a secondary endpoint, was performed. Based on the events accrued at the time of final PFS analysis, a median OS of 37.5 months was observed in the combination arm versus 33.3 months for those who received letrozole alone, a difference of 4.2 months (HR=0.813, 95% CI: 0.492, 1.345), which was not statistically significant. A follow-up OS analysis will be conducted following the accrual of additional events. The combination of palbociclib and letrozole was generally well-tolerated and the safety profile of the combination was consistent with previously reported data. Pfizer continues to work with the FDA and other regulatory authorities to define the appropriate regulatory path forward for palbociclib.

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