Ibrance Trial Stopped Early Because of Strong Evidence of Drug's Efficacy in Metastatic ER+ HER2- Breast Cancer

“Pfizer Inc. PFE, +1.01% today announced that the Phase 3 PALOMA-3 trial for IBRANCE® (palbociclib) met its primary endpoint of demonstrating an improvement in progression-free survival (PFS) for the combination of IBRANCE plus fulvestrant compared with fulvestrant plus placebo in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer following 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 (DMC). These are the first randomized Phase 3 trial results for IBRANCE, a new anti-cancer medicine with the novel mechanism of cyclin-dependent kinase 4/6 (CDK 4/6) inhibition.

“ ‘The results of this trial are especially important because they help us understand the potential of IBRANCE to improve outcomes in patients with this difficult to treat cancer. We’re gratified to be able to stop the trial early and are engaging in discussions with health authorities regarding a regulatory path forward,’ said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology.

“The adverse events observed with IBRANCE in combination with fulvestrant in PALOMA-3 were generally consistent with their respective known adverse event profiles. Detailed efficacy and safety results from PALOMA-3 will be submitted for presentation at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.”


FDA Approves Palbociclib/Ibrance for HER2-Negative, Advanced Breast Cancer

“Federal health regulators on Tuesday approved a highly anticipated medicine from Pfizer Inc. to treat postmenopausal women with a certain type of advanced breast cancer who have not already taken other drugs.

“The Food and Drug Administration approved Ibrance for women who have tumors that do not contain a protein known as HER-2. Ibrance, known generically as palbociclib, works by blocking molecules linked to .

“Pharmaceutical industry analysts expect Ibrance to grow into a mega-blockbuster, with annual sales as high as $4 billion by 2020.

“The drug is intended to be used in combination with another cancer medication known generically as letrozole.

“The FDA granted the drug accelerated approval—more than two months ahead of its April 13 target date—based on a 165-patient study showing that it slowed the progression of . Patients taking Ibrance and letrozole lived 20.2 months on average before their tumors worsened. That was about twice as long as the benefit for women in a comparison group who only received letrozole. The study is ongoing and it’s not yet clear whether Ibrance’s benefits result in increased survival times for patients.”