The remarkable results of Apelix in the field of anti-breast cancer

Alpelisib (Alpelisib), as an innovative drug, has shown impressive efficacy in patients with HR-positive, HER2-negative breast cancer who have failed first-line hormone therapy. Its unique mechanism of action lies in selectively inhibiting the PI3K pathway, which plays a key role in a variety of tumor types, including breast cancer, ovarian cancer, lung cancer, etc. The research of apelvis has progressed rapidly and has become a highly efficient and selective PI3K inhibitor, specifically targeting the p110-α isoform. Compared with traditional chemotherapy drugs, Apelvis can act on tumor cells more accurately and reduce damage to healthy cells.

In May 2019, the U.S. Food and Drug Administration (FDA) officially approved the combination of apelvis and fulvestrant for the treatment of patients with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer that has progressed on hormonal therapy. This approval was based on a series of compelling clinical study results. In relevant clinical studies, the treatment regimen of apelvis combined with fulvestrant has shown significant advantages. Compared with the placebo group, the progression-free survival (PFS) of patients treated with apelvis was significantly prolonged, reaching 11.0 months, while the placebo group was only 5.7 months. In addition, at 12 months, the PFS percentage of patients in the apelvis group was as high as 46.3%, which was much higher than the 32.9% in the placebo group.

What is more worth mentioning is that in patients with PIK3CA mutations, the therapeutic effect of apelvis is more prominent. These patients had significantly improved progression-free survival compared with patients without PIK3CA mutations. This finding further validates the potential of PI3K as an important therapeutic target for patients who have progressed on endocrine therapy.