How effective is Alpelisib-Piqray in treating breast cancer?

In preclinical and clinical trials,Alpelisib-Piqray, a selective inhibitor of PI3K, has been shown to be effective in combination with endocrine therapy in HR+ PIK3CA-mutated advanced breast cancer. Currently, the synergistic effect of Alpelisib in combination with targeted drugs has been widely reported. The phosphoinositide3-kinase (PI3K) signaling pathway is known for its important role in cancer growth, proliferation, and migration.

The efficacy of Piqray was studied in the SOLAR-1 trial, a randomized trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic cancer whose cancer progressed during or after receiving an aromatase inhibitor. Trial results showed that in patients whose tumors had PIK3CA mutations, adding apelvis to fulvestrant significantly prolonged progression-free survival (median 11 months vs. 5.7 months). Another major study involved 340 patients with advanced cancer who had PIK3CA mutations and whose hormone therapy had not responded or whose cancer had recurred. Patients who received apelvis plus fulvestrant lived an average of 11 months without worsening of their condition, while those who received a placebo lived about six months.

The original drug of Apellis is not marketed in the country and therefore cannot be included in medical insurance. There are European and Indian versions of the original Apelvis drug sold overseas. The ingredients are basically the same. The price of the European version of 150mg*56 tablets per box may be more than 4 RMB 40,000 ( (The price may fluctuate due to the exchange rate), The price of the Indian version150mg*28 tablets per box may be more than 5,000 yuan (the price may fluctuate due to the exchange rate). There are currently no generic versions of Apelvis produced and marketed.