BioCentury
ARTICLE | Top Story

Good PFS data for Pfizer compound

December 6, 2012 2:14 AM UTC

Pfizer Inc. (NYSE:PFE) said once-daily 125 mg oral PD-0332991 for three weeks of a four-week cycle in combination with Femara letrozole met the primary endpoint of improving median progression-free survival (PFS) vs. Femara alone in the Phase II portion of a Phase I/II trial to treat breast cancer (26.1 vs. 7.5 months, p<0.001). The PFS data are based on combined data from 66 postmenopausal women with estrogen receptor-positive, HER2-negative advanced breast cancer in part 1 of the Phase II portion of the trial and 99 postmenopausal women whose tumors revealed cyclin D1 ( CCND1; BCL1) amplification and p16 loss in part 2 of the Phase II portion. PD-0332991 plus Femara produced confirmed responses in 45% of patients vs. 31% for Femara alone. The clinical benefit rate (CBR), defined as tumor shrinkage and/or stable disease for 24 weeks or more, was 70% for PD-0332991 plus Femara vs. 44% for Femara alone. Data were presented at the San Antonio Breast Cancer Symposium. ...