Efficacy

Piqray (Alpelisib) Efficacy in Breast Cancer

Piqray, also known by its generic name alpelisib, is a medication that has been shown to be effective in the treatment of breast cancer, specifically hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. It is used in combination with fulvestrant, which is an estrogen receptor antagonist. The efficacy of Piqray was demonstrated in the SOLAR-1 clinical trial, where patients with this specific subtype of breast cancer who had progressed on or after an endocrine-based regimen showed a significant improvement in progression-free survival when treated with the combination of Piqray and fulvestrant compared to fulvestrant alone.

The results of the SOLAR-1 trial indicated that the median progression-free survival was nearly doubled for patients receiving the combination therapy involving Piqray. This improvement in progression-free survival highlights the drug's role in addressing the need for targeted therapies in the subset of breast cancer patients with PIK3CA mutations, which are known to be involved in the growth and spread of cancer cells. Piqray, as a PI3K inhibitor, specifically targets the PIK3CA mutation and is the first of its kind to be approved for this indication.

Talzenna (Talazoparib) Efficacy in Breast Cancer

Talzenna, with the generic name talazoparib, is another targeted therapy that has shown efficacy in the treatment of breast cancer. It is specifically indicated for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Talzenna is a poly (ADP-ribose) polymerase (PARP) inhibitor, a class of drugs that exploit the concept of synthetic lethality in cancer therapy. The EMBRACA trial was pivotal in demonstrating Talzenna's efficacy, where it was compared with standard chemotherapy in patients with germline BRCA1/2-mutated, HER2-negative advanced breast cancer.

In the EMBRACA trial, Talzenna significantly improved progression-free survival compared to chemotherapy, offering a new oral treatment option for patients with this challenging form of breast cancer. The trial also showed a delay in the time to clinically meaningful deterioration in patient-reported quality of life outcomes for those taking Talzenna compared to those on chemotherapy. This benefit is particularly important as it suggests that Talzenna can not only extend the time without disease progression but also maintain a better quality of life during treatment, which is a critical consideration for patients with advanced cancer.