Palbociclib: Final Phase II data

Final data from the double-blind, international Phase II PALOMA-1 (Study 1003) trial in 177 postmenopausal women with estrogen receptor-positive, HER2-negative advanced breast cancer showed that first-line treatment with once-daily 125 mg palbociclib for 3 weeks of a 4-week cycle plus Femara letrozole met the primary endpoint of improving PFS vs. Femara alone. Detailed data will be submitted for presentation at the American Association for Cancer Research meeting in San Diego in April. Interim data from the trial were reported in 2012 (see BioCentury, Dec. 10, 2012). Last year, FDA granted palbociclib breakthrough therapy designation to treat breast cancer based on interim data from PALOMA-1 (see BioCentury, April 15, 2013).

Palbociclib is in the Phase III PALOMA-2 (Study 1008), Phase III PALOMA-3 (Study 1023) and Phase III PENELOPE-B trials. PALOMA-2 is evaluating palbociclib in combination with Femara as first-line treatment of postmenopausal women with estrogen receptor-positive, HER2-negative advanced breast cancer. PALOMA-3 is evaluating palbociclib in combination with Faslodex fulvestrant to treat hormone receptor-positive, HER2-negative metastatic breast cancer in patients whose disease has progressed after prior endocrine therapy. PENELOPE-B is evaluating palbociclib plus standard endocrine therapy to treat hormone receptor-positive, HER2-negative early-stage breast cancer at an increased risk of relapse after neoadjuvant chemotherapy and surgery. ...