April 19, 2016
Pfizer Inc. has announced positive top-line results from the Phase 3 PALOMA-2 trial for IBRANCE®, an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. The study demonstrated an improvement in progression-free survival (PFS) 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 (ER+, HER2-) advanced or metastatic breast cancer who had not received previous systemic treatment for their advanced disease.
This PALOMA-2 trial offers positive evidence for IBRANCE with letrozole in the first-line setting, which was first studied in the Phase 2 PALOMA-1 trial. These data will support additional planned global regulatory submissions and a request for conversion of the accelerated approval for IBRANCE to regular approval in the United States. Detailed safety and efficacy results from PALOMA-2 will be submitted for presentation at the 2016 Annual Meeting of American Society of Clinical Oncology (ASCO).
“PALOMA-2 represents the third randomized study to demonstrate the benefit of IBRANCE when added to hormonal therapy in the management of women with ER+, HER2- advanced breast cancer. IBRANCE remains the only CDK 4/6 inhibitor with Phase 3 data in this disease. These results provide confirmatory evidence for PALOMA-1 and will be used to support regulatory submissions around the world, including a request for conversion of IBRANCE from accelerated to full approval in the United States. We look forward to sharing the detailed results of PALOMA-2 with the oncology community and advancing our discussions with regulatory authorities,” said Dr. Mace Rothenberg, MD, chief medical officer, Pfizer Oncology & senior vice president, Global Product Development, Oncology.