Alpelisib is a targeted drug for PIK3CA-mutated breast lesions, which has shown significant efficacy in delaying disease progression in multiple clinical studies. Its combination with fulvestrant provides new hope for survival for patients with advanced or metastatic breast lesions.

Alpelisib studies have proven to significantly delay disease progression

Clinical trial data support

The SOLAR-1 study showed that for patients with HR+/HER2- advanced breast lesions carrying PIK3CA mutations, the median progression-free survival (PFS) of alpelisib combined with fulvestrant was 11.0 months, while the control group was only 5.7 months. About 35% of patients had a lesion volume reduction of more than 30%, and the disease control rate was significantly improved. The results of this study directly promoted the approval of Alpelisib by the US FDA.

Improved long-term survival rate

Follow-up data showed that the 2-year survival rate of patients treated with Alpelisib was about 40% higher than that of traditional regimens. For patients who have failed treatment with CDK4/6 inhibitors in the past, Alpelisib can still extend the median PFS to 7.4 months. The generic drug produced by Laos Lucius is 150mg*28 tablets, which lowers the threshold for treatment.

Clarifying the clinical value of Alpelisib will help patients build confidence in treatment. The following content will analyze its core mechanism of action.

Target of Alpelisib

Alpelisib breaks the balance between proliferation and survival of diseased cells by precisely inhibiting the key signaling pathways of diseased cells. The specificity of its target provides a scientific basis for precision treatment.

PI3Kα signaling pathway inhibition

Alpelisib selectively inhibits the PI3Kα subtype and blocks the activation of the PI3K/AKT/mTOR signaling pathway. PIK3CA mutations lead to continuous activation of this pathway, promoting the growth and metastasis of diseased cells. Alpelisib can reverse this process, benefiting about 80% of patients with mutations.

Overcoming resistance to endocrine therapy

For patients who progress on endocrine therapy, PI3Kα inhibition can restore the sensitivity of the lesion to hormone therapy. Clinical data show that combined with fulvestrant can increase the objective response rate (ORR) of patients with PIK3CA mutations to 26%, significantly better than single endocrine therapy.

Understanding the mechanism of action of the drug helps to optimize the treatment plan. The following content will explain the superior population suitable for Alpelisib treatment.

For which populations Alpelisib is more effective

The efficacy of Alpelisib is closely related to the patient's genetic characteristics and treatment history. Accurate screening of the applicable population can maximize the benefits of treatment.

Patients with PIK3CA mutations

Only patients with FDA-approved tests that confirm the presence of PIK3CA mutations can use it. About 40% of patients with HR+/HER2- breast lesions carry this mutation, and the disease control rate of Alpelisib in this population can reach 63%. Mutation detection must be completed through lesion tissue or liquid biopsy.

Patients who have failed previous endocrine therapy

For patients who have progressed after receiving CDK4/6 inhibitors or aromatase inhibitors, Alpelisib combined with fulvestrant can prolong progression-free survival. Studies have shown that the median PFS for second-line treatment is 7.4 months and for third-line treatment is 5.5 months. The Indian original drug specification of 200mg*14 tablets and the dose needs to be adjusted according to weight.

During treatment, fasting blood sugar and liver function should be monitored regularly, and medical treatment should be sought promptly in case of severe rash or diarrhea. It is recommended that patients take the entire tablet with meals at a fixed time every day, and skip the daily dose if the dose is missed for more than 9 hours. Through standardized medication and doctor-patient collaboration, Alpelisib is expected to bring long-term survival opportunities to more patients with breast lesions.