Efficacy

Piqray (alpelisib) Efficacy in Breast Cancer

Piqray (alpelisib) is a medication approved for the treatment of breast cancer, specifically for postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. The efficacy of Piqray was demonstrated in the SOLAR-1 clinical trial, which showed that when combined with fulvestrant, Piqray significantly prolonged progression-free survival (PFS) compared to fulvestrant alone in patients with a PIK3CA mutation. Patients treated with the combination had a median PFS of 11.0 months versus 5.7 months for those receiving fulvestrant plus placebo, indicating a substantial improvement in the time patients lived without disease progression.

It is important to note that the efficacy of Piqray is contingent upon the presence of a PIK3CA mutation in the tumor, which occurs in approximately 40% of hormone receptor-positive, HER2-negative breast cancers. The presence of this mutation can be detected through an FDA-approved test, which is used to identify patients who are likely to benefit from Piqray. For patients without a PIK3CA mutation, the benefits of Piqray are less clear, and it is not typically recommended as part of the treatment regimen.

Orserdu (elacestrant) Efficacy in Breast Cancer

Orserdu (elacestrant) is a selective estrogen receptor degrader (SERD) that is being investigated for the treatment of estrogen receptor (ER)-positive breast cancer. While Orserdu is not yet approved by regulatory agencies at the time of this writing, clinical trials are underway to evaluate its efficacy. Preliminary data from these trials suggest that Orserdu may have potential as a treatment option for patients with advanced or metastatic ER-positive, HER2-negative breast cancer, including those who have previously received endocrine therapy.

One of the key trials assessing Orserdu is the EMERALD Phase 3 trial, which is designed to compare the efficacy and safety of Orserdu to standard endocrine therapies in patients with ER-positive, HER2-negative breast cancer who have progressed on prior endocrine therapy. Results from this trial are eagerly anticipated, as they will provide more definitive evidence regarding Orserdu's efficacy and its potential role in the treatment landscape of breast cancer. Until such data are available and regulatory approvals are granted, the use of Orserdu remains investigational.