Biotech Values

[DewDiligence]

Re: Phase-2 data for PFE’s PD-991

This was a 2-part trial where part 2 used biomarker enrichment:

http://finance.yahoo.com/news/pfizer-presents-phase-2-data-133000916.html

The focus of Phase 2 evaluation of PD-991 was to measure the clinical activity of PD-991 in combination with letrozole versus letrozole alone in post-menopausal women with ER+, HER2- locally advanced or metastatic breast cancer. In Part 1, 66 patients were enrolled. Preliminary results were presented in May 2012 at the IMPAKT Breast Cancer Conference in Brussels, Belgium, and showed statistically significant improvement in median PFS in the PD-991 plus letrozole arm versus the letrozole arm. Part 2 enrolled 99 additional patients whose tumors were selected for presence of biomarkers: cyclin D1 amplification and/or p16 loss. The results presented here at SABCS reflect the combined interim data analysis of parts 1 and 2 of the Phase 2 evaluation [emphasis added].

Thus, it’s reasonable to infer that the HR for PFS in part 2 of the study was even better than the superb blended HR of 0.37 (95% CI: [0.21-0.63]).