Efficacy

Efficacy of Piqray (Alpelisib) in Breast Cancer

Piqray (alpelisib) is a medication specifically designed for the treatment of breast cancer. It is a PI3K inhibitor that is used in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. The efficacy of Piqray was demonstrated in the SOLAR-1 clinical trial, which showed a significant improvement in progression-free survival (PFS) compared to the control group. Patients treated with the combination of Piqray and fulvestrant had a median PFS of 11.0 months compared to 5.7 months for those receiving fulvestrant alone.

It is important to note that the presence of a PIK3CA mutation in tumor tissue and/or a circulating tumor DNA test is required for the initiation of treatment with Piqray. This mutation is found in approximately 40% of HR-positive, HER2-negative breast cancers. The identification of this mutation allows for a more targeted approach to treatment, ensuring that patients who are most likely to benefit from Piqray are the ones receiving it.

Efficacy of Trodelvy (Sacituzumab Govitecan-hziy) in Breast Cancer

Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy has shown significant efficacy in this patient population, which is known to have limited treatment options and a poor prognosis. In the ASCENT study, Trodelvy significantly improved median PFS to 5.6 months compared to 1.7 months with chemotherapy. Moreover, the median overall survival was 12.1 months for patients treated with Trodelvy, compared to 6.7 months for those receiving chemotherapy.

The efficacy of Trodelvy highlights its role as a valuable treatment option for patients with metastatic TNBC, a particularly aggressive form of breast cancer. The approval of Trodelvy was based on the results of the clinical trial which demonstrated a significant improvement in overall survival and progression-free survival. Its mechanism of action involves the delivery of the cytotoxic drug, SN-38, directly to cancer cells by targeting the Trop-2 antigen, which is expressed in the majority of TNBC tumors.