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Palbociclib Trial Stopped Early Due To Efficacy
The phase III PALOMA-3 study has met its primary endpoint of demonstrating an improvement in progression-free survival (PFS) for the combination of palbociclib (Ibrance, Pfizer) plus fulvestrant (Faslodex, AstraZeneca) compared with fulvestrant plus placebo in women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2–) metastatic breast cancer after disease progression during or after endocrine therapy.
The study was stopped early due to efficacy based on an assessment by an independent data-monitoring committee.
These are the first randomized phase III trial results for palbociclib, a new anti-cancer medication with the mechanism of cyclin-dependent kinase 4/6 (CDK 4/6) inhibition.
Ibrance (palbociclib) was approved by the FDA in February 2015 as a first-line treatment for women with advanced or metastatic estrogen receptor positive (ER+), HER2– breast cancer. Palbociclib, in combination with letrozole, is indicated for the treatment of postmenopausal women with ER+/HER2– advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Continued approval for this indication may be contingent on the verification and description of clinical benefit in a confirmatory trial. A confirmatory phase III study, PALOMA-2, is fully enrolled. Palbociclib is not approved for the use being investigated in the PALOMA-3 study or for any indication in any market outside the U.S.
The PALOMA-3 trial was a randomized, double blind study designed to assess the PFS of palbociclib (125 mg once daily for 3 out of 4 weeks in repeated cycles) in combination with fulvestrant (500 mg administered intramuscularly on days 1 and 15 of cycle 1, and then on day 1 of each subsequent 28-day cycle) compared with fulvestrant plus placebo in 521 women with HR+/HER2– metastatic breast cancer whose disease has progressed during or after endocrine therapy. PFS was defined as the time from randomization to the time of disease progression or death from any cause.
Source: Pfizer; April 15, 2015.