Date of first round report: 1 September 2016 Date of second round report: 30 January 2017



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Results for the primary efficacy outcome – investigator assessment


The final analysis of the primary progression-free survival (PFS) endpoint was performed after the first 331 patients had documented progressive disease (PD) or death based on investigator assessment. The median follow-up time for the palbociclib plus letrozole arm was 23.0 months (95% CI: 22.6-23.4) and for the placebo plus letrozole arm was 22.3 months (95% CI: 21.9-22.9).

  • 43.7% in the treatment arm and 61.7% of the control arm had events

  • estimated HR was 0.576 (95% CI: 0.463-0.718; 1-sided p<0.000001) in favour of palbociclib plus letrozole

  • median PFS was 24.8 months (95% CI: 22.1-NE) for palbociclib plus letrozole and 14.5 months (95% CI: 12.9-17.1) for placebo plus letrozole

Comment: Based on the investigator assessments, there is a statistically significant improvement in PFS for the overall population. PFS based on the BICR assessment is not provided.

Table 20: Study A5481008 Progression-free survival, objective response, duration of response, and clinical benefit/response/disease control rates (Investigator Assessment, ITT population). Source Table 3, Topline summary



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