Efficacy

Piqray (alpelisib) for Breast Cancer

Piqray (alpelisib) is a targeted therapy approved by the FDA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. This approval is specifically for use in combination with fulvestrant in postmenopausal women, and in men, who have progressed following endocrine therapy. The efficacy of Piqray was demonstrated in the SOLAR-1 clinical trial, which showed a significant improvement in progression-free survival (PFS) in patients with a PIK3CA mutation when compared to fulvestrant alone. 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.

Enhertu (fam-trastuzumab deruxtecan-nxki) for Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is an antibody-drug conjugate approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The drug has shown significant efficacy in this patient population, as evidenced by the results of the pivotal DESTINY-Breast01 trial. In this study, Enhertu demonstrated a confirmed objective response rate (ORR) of 60.9% in patients who had previously been treated with two or more HER2-targeted therapies for metastatic disease. The median duration of response (DoR) was 14.8 months, indicating a substantial period of tumor control.

Both Piqray and Enhertu represent significant advancements in the treatment of specific subtypes of breast cancer, offering new hope for patients with limited options. The targeted nature of these therapies allows for a more personalized approach to treatment, which is a key aspect of modern oncology. As with all treatments, the efficacy of these drugs must be evaluated on an individual basis, taking into account the specific characteristics of the patient's cancer and their overall health status.

It is important to note that while these therapies have been approved for use in certain populations, ongoing research continues to evaluate their full potential and explore additional indications. The landscape of breast cancer treatment is evolving rapidly, and Piqray and Enhertu are at the forefront of this change, offering new mechanisms of action against the disease. As new data emerge, the clinical guidelines for these drugs may expand to include broader patient populations, further enhancing their impact on breast cancer care.