Pfizer Inc., an American multinational pharmaceutical corporation, announced the first-ever recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Five grants totaling more than $4 million in funding were awarded to support clinical research projects investigating Ibrance (palbociclib), an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, in advanced breast cancer for 2015.
CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular progression. Ibrance is approved by the FDA for use in combination with letrozole as a treatment for 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. Simultaneously, the company announced that it will award up to $4 million in new grants through the ASPIRE Breast Cancer Research Awards Program in 2016.
“We are excited to support these five investigator-led studies, which we believe will contribute important new information to our body of knowledge about the role Ibrance plays in the treatment and clinical management of advanced breast cancer,” said Dr. Julia Perkins Smith, senior medical director, US Breast Cancer Lead, Pfizer Oncology.
“At the same time, we are looking forward to continuing the program in 2016 and further supporting investigators’ efforts in this disease area, where there is a substantial need for research that may lead to new options and improved care for metastatic breast cancer patients. Supporting the scientific and clinical exploration of our medicines both within and outside our walls is critical to our ability to make a meaningful impact on patients’ lives.”
The ASPIRE Breast Cancer Research Awards Program is an extension of ASPIRE, Pfizer’s competitive grants program. Recipients were selected through a competitive application process overseen by an independent review panel of breast cancer experts. The following five investigators and studies have been awarded grants through the program to date:
Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute – A phase Ib/IIa study of Palbociclib in combination with Everolimus and Exemestane in postmenopausal women with estrogen receptor positive and HER2 negative metastatic breast cancer;
Ewa Mrozek, MD, The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute – A phase II Trial of primary endocrine therapy with combination of Fulvestrant and Palbociclib in elderly patients with hormone responsive breast cancer who have inoperable tumor or operable tumor but cannot undergo surgery due to frailty;
Oana Danciu, MD, University of Illinois at Chicago – A single arm phase II study of Palbociclib in combination with Tamoxifen as first line therapy for metastatic hormone receptor positive breast cancer;
Cesar Augusto Santa-Maria, MD, Northwestern University – A single arm phase II study of Palbociclib in patients with metastatic HER2-positive or triple negative breast cancer with brain metastasis;
Filipa Lynce, MD, Lombardi Comprehensive Cancer Center at Georgetown University Medical Center – A phase II safety study of Palbociclib in combination with Letrozole in African American women with hormone receptor positive HER2 negative advanced breast cancer.
For the new 2016 grants, investigators are encouraged to submit for consideration proposals for innovative research in several areas. Some areas of research interest include improving the medical knowledge of palbociclib in the treatment of advanced breast cancer through exploring the safety and efficacy of novel combinations; optimizing clinical management during palbociclib treatment that addresses or improves patient compliance and convenience and/or patient reported outcomes; exploring biomarkers relevant to palbociclib in breast cancer.