Novartis' investigational combo impresses in breast cancer sub-group

Novartis has revealed positive new data for its investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) combined with fulvestrant in the treatment of breast cancer, demonstrating that the therapy met its primary endpoint.

The drug combo was proven to improve progression-free survival of the disease, while its safety profile was shown to be consistent with previous studies.  

Specifically, the therapy is being trialled in postmenopausal women and men with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) PIK3CA-mutant advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor. This group represents approximately 40% of HR+ breast cancer patients, and there are currently no approved PI3K inhibitors for treatment of the disease.

"BYL719 is the only alpha-specific PI3K inhibitor and the first one to show potential increased benefit and acceptable tolerability for patients," said Dr Samit Hirawat, Head of Novartis Oncology’s Global Drug Development. "We are encouraged by the results observed in the SOLAR-1 study and look forward to submitting the data to an upcoming medical congress and starting discussions with health authorities worldwide."

The full findings of the study will be unveiled at an upcoming conference. With this new data under its belt, Novartis has confirmed it now plans to initiate discourse with health authorities around the world to push forward with bringing the combo to market.

 --------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.