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Palbociclib Misses OS Endpoint in PALOMA-3 Breast Cancer Study

Silas Inman @silasinman
Published: Monday, Jun 25, 2018

Nicholas Turner, MD, PhD

Nicholas Turner, MD, PhD
The combination of palbociclib (Ibrance) and fulvestrant (Faslodex) failed to improve overall survival (OS) compared with fulvestrant and placebo in the phase III PALOMA-3 trial for patients with HR-positive, HER2-negative metastatic breast cancer who received prior endocrine therapy, according to Pfizer, the developer of the CDK4/6 inhibitor.

OS was a secondary endpoint for the PALOMA-3 trial. The primary endpoint of progression-free survival (PFS) was previously reported and led to FDA approval for palbociclib plus fulvestrant for pretreated women with HR+/HER2- metastatic breast cancer. In findings published in The Lancet Oncology,1 the median PFS was 9.5 months with palbociclib/fulvestrant compared with 4.6 months for fulvestrant alone (HR, 0.46; 95% CI, 0.36-0.59; P <.0001).

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