Pfizer breast cancer trial stopped following promising results
pharmafile | April 15, 2015 | News story | Sales and Marketing | ASCO, FDA, Pfizer, ibrance, palbociclib
Regulators have stopped a Phase III clinical trial of Pfizer’s Ibrance early after it demonstrated improved survival in women with breast cancer.
Ibrance (palbociclib) was approved by the FDA in February 2015 as a first-line treatment for women with advanced or metastatic oestrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer.
This latest study is in a different group of patients – those with metastatic hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has progressed despite endocrine therapy.
Ibrance is not approved in this patient group, but Pfizer says the positive results of the trial – which will be published in full at the American Society of Clinical Oncology (ASCO) conference in Chicago in May – will help them when making future regulatory filings.
“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,” says Dr Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer oncology.
These are the first randomised Phase III trial results for Ibrance, a new anti-cancer medicine with the novel mechanism of cyclin-dependent kinase 4/6 inhibition.
Pfizer is banking on the breast cancer treatment to boost flagging sales. When the US firm published its full-year 2014 financial results – when revenues declined by 3% year-on-year – chief executive Ian Read highlighted the US approval of Ibrance as a means by which the company will achieve ‘continued momentum with our pipeline’ in 2015.
Lilian Anekwe
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