Summary of clinical trial data of Apelvis-Piqray in the field of lung cancer

Alpelisib (generic name: Alpelisib), trade name: Piqray, is a targeted therapy drug mainly used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. In recent years, with the deepening of research on the PI3K pathway, clinical trials of apelvis in the field of lung cancer have gradually attracted attention. Although its main indication is breast cancer, its potential in other types of cancer is also being explored, particularly in patients with lung cancer.

According to the approval of the U.S. Food and Drug Administration (FDA), the combination of apelvis and endocrine therapy fulvestrant has shown good clinical effects. This combination therapy is targeted at patients who have progressed despite standard endocrine therapy. The FDA also approved the therascreen PIK3CA RGQ PCR Kit as a companion diagnostic tool for the detection of PIK3CA mutations in tissue and liquid biopsies. This testing method ensures that patients have the appropriate genetic profile before receiving Apelvis treatment, thereby improving the accuracy and effectiveness of treatment.

Apelixis is the first PI3K inhibitor proven to have clinical significance in the treatment ofHR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer patients. In the SOLAR-1 trial, researchers randomized 572 postmenopausal women and men, all of whom had HR-positive, HER2-negative advanced or metastatic breast cancer whose cancer had progressed while or after receiving an aromatase inhibitor. The trial results showed that in patients whose tumors had PIK3CA mutations, the use of apelvis significantly prolonged progression-free survival (PFS), with a median of 11 months, compared with only 5.7 months in the control group. This data reflects the important value of apelix in clinical treatment.

Not only that, another major study involved340 patients with advanced breast cancer with PIK3CA mutations who had failed to respond to hormone therapy or had relapsed. The results showed that the average progression-free survival of patients treated with apelvis combined with fulvestrant was 11 months, which was significantly better than that of patients treated with placebo and fulvestrant. The average progression-free survival of this group was approximately 6 months. These study data clearly show that the addition of apelvis can significantly improve patient outcomes.

Although current research on Apelvis is mainly focused on breast cancer, with the development of With a deeper understanding of the mechanism of action of the PI3K pathway, researchers have begun to explore its application potential in other tumor types such as lung cancer. For example, in some small cell lung cancers and non-small cell lung cancer (NSCLC), the incidence of PIK3CA mutations is increasingly recognized as potentially affecting patient prognosis and response to treatment. This provides a basis for clinical trials of Apelvis in the field of lung cancer.

Clinical trials are often designed to take into account patients' genetic characteristics in order to identify groups of patients most likely to benefit. When conducting research on Apelvis related to lung cancer, researchers may also use a structure similar to the SOLAR-1 trial to conduct a randomized controlled trial to evaluate the efficacy and safety of Apellis combined with existing therapies (such as chemotherapy or immunotherapy). At the same time, the corresponding PIK3CA mutation detection will also be included in clinical standards to ensure the accuracy of treatment.

Reference materials:https://www.piqray.com/