Ibrance + fulvestrant PALOMA-3 study results for breast cancer announced at ASCO- Pfizer

Pfizer Inc. announced study results demonstrating Ibrance (palbociclib) in combination with fulvestrant was superior to treatment with a standard of care, fulvestrant, by significantly extending progression-free survival (PFS) in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed during or after endocrine therapy (HR 0.42, median PFS, 9.2 vs. 3.8 months, in their respective arms, p<0.000001).

Results from the Phase III PALOMA-3 study were featured in a press briefing during the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) and will be presented as a late-breaker on Monday, June 1 at 8:00 a.m. CDT (Abstract #LBA502). The results will also be simultaneously published online by The New England Journal of Medicine. The Principal Investigator for the study, Nicholas C. Turner, MD, PhD, consultant medical oncologist at The Royal Marsden and Institute of Cancer Research in London, United Kingdom, will present these data.

The PALOMA-3 results demonstrate that palbociclib in combination with fulvestrant more than doubled the time before disease progression compared to fulvestrant alone, and suggest that palbociclib could be a promising treatment option for women with HR+, HER2- metastatic breast cancer after progression on endocrine therapy.

Comment: Based on the results of PALOMA-3, Pfizer is in discussions with global regulatory authorities to determine next steps to potentially make palbociclib available for women with HR+, HER2- metastatic breast cancer whose disease has progressed following endocrine therapy. Pfizer intends to file a Marketing Authorisation Application for palbociclib to the European Medicines Agency (EMA) in the second half of 2015. In addition, Pfizer will work closely with the FDA to review these data and determine next steps for potential inclusion in the U.S. label. Palbociclib, under the brand name Ibrance, was given accelerated approval in combination with letrozole by the FDA in February 2015 for the treatment of postmenopausal women with estrogen receptor-positive (ER+)/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. A confirmatory Phase III trial, PALOMA-2, is fully enrolled.