Pfizer Announces Overall Survival Results from Phase 3 PALOMA-3 Trial of IBRANCE in HR+, HER2- Metastatic Breast Cancer

Pfizer (NYSE:PFE) today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE^® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy.

As quoted in the press release:

“While the difference in overall survival narrowly missed the threshold for statistical significance – a high bar for any trial in this patient population – it is similar, in absolute terms, to the improvement in median progression-free survival previously demonstrated in this trial.¹ We are encouraged by these results, which build on the compelling clinical benefit delivered by IBRANCE,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “IBRANCE in combination with endocrine therapy has transformed the treatment landscape for patients with HR+, HER2- metastatic breast cancer.”

PALOMA-3 met its primary endpoint of progression-free survival (PFS) at interim analysis and results were published in The New England Journal of Medicine in June 2015; updated PFS data were later presented at the 2016 San Antonio Breast Cancer Symposium. The trial demonstrated a statistically significant and clinically meaningful improvement in PFS for IBRANCE plus fulvestrant compared to placebo plus fulvestrant. PFS is a well-established measure of clinical benefit in metastatic breast cancer trials.² IBRANCE in combination with fulvestrant has been approved in more than 80 countries around the world based on the PFS demonstrated in PALOMA-3.

Click here to read the full press release.