Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Pfizer has reported positive results of its PALOMA-1 study, a randomised Phase II trial of palbociclib (PD-0332991) in combination with letrozole to treat breast cancer.
Subscribe to our email newsletter
According to the company, PALOMA-1 met its primary endpoint by prolonging progression-free survival (PFS) compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.
In women treated with the combination drug, the median PFS was 20.2 months, a significant improvement compared to the 10.2 months of PFS in women who received letrozole alone.
The company said that final results for the secondary efficacy endpoints of duration of treatment and clinical benefit rate showed superiority in the combination arm compared to letrozole alone.
Per the PALOMA-1 trial protocol, an initial assessment of overall survival (OS), a secondary endpoint, was also conducted.
Based on the events at the time of assessment, a median OS of 37.5 months was observed in the combination arm versus 33.3 months for those who received letrozole alone, a difference of 4.2 months.
The palbociclib-letrozole combination was well-tolerated and the safety profile of the combination was consistent with previously reported data.
The most common adverse events in the combination arm were neutropenia, leukopenia, fatigue and anemia.