Pfizer's palbociclib meets PFS, misses OS in breast cancer

Pfizer Inc. (NYSE:PFE) presented updated data on the primary endpoint of progression-free survival (PFS) and initial data on the secondary endpoint of overall survival (OS) data from the Phase II PALOMA-1 trial of palbociclib as first-line treatment of estrogen receptor-positive, HER2-negative advanced breast cancer. In 165 evaluable women, once-daily palbociclib plus Femara letrozole from Novartis AG (NYSE:NVS; SIX:NOVN) led to a median PFS of 20.2 months vs.10.2 months for Femara alone (HR=0.488, 95% CI: 0.319, 0.748, p=0.0004). An initial analysis of median OS showed palbociclib plus Femara led to a non-significant improvement vs. Femara alone (37.5 vs. 33.3 months, p=0.2105). ...