Can Alpelisib-Piqray be combined with fulvestrant?

Alpelisib-Piqray is a drug used to treat certain types of breast cancer and is sold under the brand name Piqray. It is used with fulvestrant and is administered orally. It is an alpha-specific PI3K inhibitor that was approved for medical use in the United States in May 2019.

In a clinical study , the efficacy of apelvis plus fulvestrant showed a median progression-free survival (PFS) of 11.0 months, compared with 5.7 months in the placebo group. At 12 months, the percentage of patients with PFS was 46.3% in the apelvis and fulvestrant group and 32.9% in the placebo and fulvestrant group. Overall response among all patients in the trial was higher with apelvis and fulvestrant than with placebo and fulvestrant, as were clinical benefit and tumor response. When comparing these results to a cohort without PIK3CA mutations, a significant improvement in PFS was seen in patients with PIK3CA mutations. The median PFS was 7.4 months for apelvis and fulvestrant and 5.6 months for placebo and fulvestrant. At 12 months, PFS was 28.4% for apelvis and fulvestrant and 22.2% for placebo and fulvestrant.

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.