Pfizer's Ibrance fails to improve OS in Phase III for breast cancer
Pfizer Inc. (NYSE:PFE) said Ibrance palbociclib plus Faslodex fulvestrant failed to significantly improve overall survival (OS), a secondary endpoint, vs. placebo plus Faslodex in the Phase III PALOMA-3 trial to treat hormone receptor-positive, HER2-negative metastatic breast cancer in patients whose disease has progressed after prior endocrine therapy. The company said the trial design "was not optimized" to detect a statistically significant difference in OS.
Pfizer told BioCentury that inclusion of PALOMA-3's final OS data in Ibrance's labels will be subject to "local health authority assessment." Detailed data will be presented at a medical meeting...