PALOMA 2 trial of Ibrance (palbociclib) + letrozole for breast cancer is published in NEJM.- Pfizer

Pfizer Inc. announced that detailed results from the Phase III PALOMA-2 trial were published in The New England Journal of Medicine. These data, presented at the 52nd American Society of Clinical Oncology (ASCO) Annual Meeting in June, further demonstrate the clinical benefit of Ibrance (palbociclib) as initial therapy for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer.

The PALOMA-2 study showed the combination of Ibrance and letrozole extended progression-free survival (PFS), or the amount of time before tumor growth, by more than 10 months compared with letrozole plus placebo. Further, the study demonstrated that the median PFS of the Irbance and letrozole combination exceeded two years – making it the first and only treatment for this population of women to do so in a randomized Phase III study.In the trial, median PFS for women treated with Ibrance plus letrozole was 24.8 months (95% CI, 22.1-not estimable) compared with 14.5 months (95% CI, 12.9-17.1) for women treated with letrozole plus placebo (HR=0.58 [95% CI, 0.46-0.72], p<0.001), a 42% reduction in the risk of disease progression.Safety results were consistent with PALOMA-1 and no major unexpected safety findings were observed.

See-"Palbociclib and Letrozole in Advanced Breast Cancer"-Richard S. Finn, M.D., Miguel Martin, M.D., Hope S. Rugo, M.D.,et al., N Engl J Med 2016; 375:1925-1936 November 17, 2016DOI: 10.1056/NEJMoa1607303.