Success for Ibrance (palbociclib)+ fulvestrant in PALOMA-3 trial for metastatic breast cancer- Pfizer

Pfizer Inc. announced that the Phase III PALOMA-3 trial for Ibrance (palbociclib) met its primary endpoint of demonstrating an improvement in progression-free survival (PFS) for the combination of Ibrance plus fulvestrant( Faslodex) compared with fulvestrant plus placebo in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer following disease progression during or after endocrine therapy. The study was stopped early due to efficacy based on an assessment by an independent Data Monitoring Committee (DMC). These are the first randomized Phase III trial results for Ibrance, a new anti-cancer medicine with the novel mechanism of cyclin-dependent kinase 4/6 (CDK 4/6) inhibition. The adverse events observed with Ibrance in combination with fulvestrant in PALOMA-3 were generally consistent with their respective known adverse event profiles. Detailed efficacy and safety results from PALOMA-3 will be submitted for presentation at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.

Comment: Ibrance in combination with letrozole (Femara) has accelerated approval from the FDA for treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease and consequent on Phase II results and an ongoing confirmatory Phase III trial PALOMA 2 .