Novartis has recently announced the results of their Phase II BYLieve trial, which is investigating Piqray® (alpelisib) as a treatment for hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic or advanced breast cancer. The full data were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS), which was held last week.
Piqray for Breast Cancer
The BYLieve trial found that Piqray had a viable safety and efficacy profile, which means it could provide a benefit for a subgroup of breast cancer patients. It was split into three cohorts, with highlights including:
- Median overall survival improvement after 18 months of follow-up was 26.4 months
- 48.7% of patients were alive without disease progression after six months
- Efficacy was demonstrated through exploratory biomarkers and post-hoc analysis
- The most common adverse events (AEs) were nausea, rash, hyperglycemia, and diarrhea
- No new safety signals were observed
- It was confirmed that Piqray is a targeted therapy for PIK3CA as a driver oncogene
These data are very exciting, as they point to Piqray as a viable treatment option for patients with HR+/HER2- advanced or metastatic breast cancer.
About Metastatic Breast Cancer
Metastatic breast cancer, also referred to as stage IV breast cancer, is breast cancer that has spread to other parts of the body. Most commonly, it moves to the lungs, liver, brain, and bones. Symptoms vary depending on where the cancer has spread; for example, sudden bone pain is present if it has spread there. If it has metastasized to the liver, symptoms include fatigue, fever, weight loss, abdominal pain, weakness, and poor appetite. In cancer that has spread to the brain, one might experience problems with memory, headaches, and changes in vision and speech. Lung symptoms include shortness of breath, coughing, and breathing issues.
Looking specifically to HR+/HER- breast cancer, HR+ means that one’s cancer is fueled by hormones, whether that’s estrogen receptors or progesterone receptors. HER- means that the human epidermal growth factor receptor 2 is functioning properly.
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