Pfizer Reports Positive Top-Line Results For Phase 3 PALOMA-2 Trial Of IBRANCE

(RTTNews) - Pfizer Inc. (PFE) announced positive top-line results from the Phase 3 PALOMA-2 trial for IBRANCE (palbociclib), an oral inhibitor of cyclin-dependent kinases 4 and 6. The study met its primary endpoint by demonstrating an improvement in progression-free survival for the combination of IBRANCE plus letrozole compared with letrozole plus placebo in post-menopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer who had not received previous systemic treatment for their advanced disease.

The company said the PALOMA-2 trial provides confirmatory evidence for IBRANCE in combination with letrozole in the first-line setting, which was first studied in the Phase 2 PALOMA-1 trial. The data will support additional planned global regulatory submissions and a request for conversion of the accelerated approval for IBRANCE to regular approval in the U.S.

Based on the results of PALOMA-1, IBRANCE first was approved by the U.S. FDA in February 2015 for the treatment of postmenopausal women with ER+, HER2- advanced breast cancer in combination with letrozole as initial endocrine-based therapy for their metastatic disease.