Pfizer Inc. announced the launch of a competitive, peer-reviewed grants programme to support clinical research projects investigating Ibrance (palbociclib) in advanced breast cancer. The multi-year programme, which will award a total of up to $3 million in grants to investigators in the United States, is an extension of Pfizer’s Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) initiative. It is the first ASPIRE programme to focus on breast cancer research.
Ibrance received accelerated approval by the US Food and Drug Administration in February 2015 for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
“We believe the ASPIRE Breast Cancer Research Awards will contribute important information to our body of knowledge about the role Ibrance plays in the treatment and clinical management of advanced breast cancer, and will complement the robust clinical development programme we have ongoing,” said Dr. Julia Perkins Smith, senior medical director, US Breast Cancer Lead, Pfizer Oncology. “Through these awards, we also look forward to supporting the mission of the ASPIRE programme to further academic research and nurture the career development of emerging investigators in a disease area of high unmet medical need.”
“This is an exciting opportunity to gain a better understanding of the efficacy and tolerability of CDK inhibition in ER+ breast cancer,” said Dr. Ruth O’Regan, head of haematology and oncology in the Department of Medicine at the University of Wisconsin School of Medicine and Public Health.
Grantees will be selected through a competitive application process overseen by an independent review panel of breast cancer experts.
The review panel encourages investigators (with a special interest for emerging researchers at Assistant Professor level or equivalent) to submit applications for innovative research in several areas. Highlights of the research of interest include: Improving the medical knowledge of palbociclib in the treatment of advanced breast cancer; Optimizing clinical management during palbociclib treatment that addresses or improves patient compliance and convenience and/or patient reported outcomes.
Ibrance is an oral inhibitor of cyclin-dependent kinases (CDKs) 4 and 6.1 CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular progression. Ibrance is indicated in the US for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The effectiveness of Ibrance in these patients is based on a study that measured progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.