Date: 2015-07-21
Type of information: Results
phase: 3
Announcement: results
Company: Novartis (Switzerland)
Product: buparlisib (BKM120)
Action
mechanism: phosphoinositide 3-kinase (PI3K) inhibitor. Buparlisib is an orally bioavailable specific oral inhibitor of the pan-class I phosphatidylinositol 3-kinase (PI3K) family of lipid kinases. It specifically inhibits class I PIK3 in the PI3K/AKT kinase (or protein kinase B) signaling pathway in an ATP-competitive manner, thereby inhibiting activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis. Dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Republic of Korea, The Netherlands, Peru, Poland, Russian Federation, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, UK, USA
Trial
details: The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor.( NCT01610284)
Latest
news: * On July 21, 2015, Novartis announced that the Phase III BELLE-2 trial of oral BKM120 (buparlisib) in combination with fulvestrant (Faslodex®) met its primary objective, demonstrating a statistically significant improvement in PFS in postmenopausal women with HR+/HER2- advanced breast cancer whose disease progressed or recurred on or after treatment with an aromatase inhibitor when compared to fulvestrant alone. The observed moderate PFS result in the overall study population and the prospective analyses in certain predefined subgroups, including patients with PIK3CA mutation assessed in archival tumor samples and circulating tumor DNA, will be discussed with the health authorities before proceeding with the regulatory submissions. In addition, the updated survival analysis will be available in the second half of 2016. * On May 11, 2012, the BELLE-2 Phase 3 trial sponsored by Novartis was published on the NIH website ClinicalTrials.gov for buparlisib and is currently ongoing.
