Studies have shown that inhibition of PI3K by Apellis treatment can induce increased transcription of the estrogen receptor (ER) in breast cancer cells. In xenograft models of ER-positive, PIK3CA-mutated breast cancer cell lines, the combination of apelisib and Fulvestrant had higher antitumor activity than either treatment alone. What is the specific therapeutic effect?

How effective is apelisib combined with Fulvestrant in treating breast cancer?

1. Trial background

In patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, PIK3CA mutations are present in approximately 40% of patients. The PI3Kα-specific inhibitor alpelisib has shown antitumor activity in early studies.

2. Trial design and setting of trial results

In a randomized phase 3 trial, apelisib (at a dose of 300mg per day) plus Fulvestrant (at a dose of 500mg every 28 days, once on day 15) was compared with placebo plus Fulvestrant in patients with HR-positive, HER2-negative, advanced breast cancer who had previously received endocrine therapy. Patients were divided into two groups based on the PIK3CA mutation status of the tumor tissue. The primary endpoint was the progression-free survival of patients in the PIK3CA mutation group assessed by the investigator; the progression-free survival of patients in the non-PIK3CA mutation group was also analyzed.

3. The results of the trial showed that

(1) In the cohort of patients with PIK3CA mutation cancer, after a median follow-up of 20 months, the progression-free survival of the apellis-Fulvestrant group was 11.0 months, while the progression-free survival of the placebo-Fulvestrant group was 5.7 months.

(2) In the cohort of patients with non-PIK3CA mutation cancer, the overall response of apellis-Fulvestrant for all patients was higher than that of placebo-Fulvestrant (26.6% vs. 12.8%).

4. Conclusion of the trial

Patients with PIK3CA mutation, HR-positive, HER2-negative advanced breast cancer who have received endocrine therapy can prolong their progression-free survival by receiving apellis-Fulvestrant.

What is the price of Apellis?

There are currently two versions of Apellis on the market. One is the Apellis Swiss Novartis export to Hong Kong, with a specification of 150mg*56 tablets, and the other is the Apellis Swiss Novartis export to India, with two specifications, 200mg*14 tablets; 150mg*28 tablets, 200mg*14 and 150mg*28 tablets.

[Warm Tips]: The above is only a reference price, and the actual price may fluctuate due to the exchange rate and other factors.