Piqray has been released in Korea

The MFDS, approved combined treatment with Fulvestrant

HR+/HER2- Variation occurs in 40% of patients

Interested in registering combined therapy benefits

The first new drug targeting the PIK3 gene in breast cancer has been released in Korea.

 

The MFDS approved Piqray (Alpelisib/50·150·200 mg' by Novartis on the 13th.

 

Piqray is HR- (+)/HER2 (-) and may be combined with the endocrine treatment Faslodex (Fulvestrant) in postmenopausal women and men with progressive or metastatic breast cancer.

 

PIK3CA positive diagnostic tests are evaluated using in vitro diagnostic medical devices licensed by the MFDS.

 

It is the first domestic PIK3 inhibitor.

 

It also obtained permission from the U.S.

 

and Europe in May 2019 and July 2020, respectively.

 

PIK3CA genetic variation is known to be a common pattern in about 40% of patients with HR+/HER2- breast cancer.

 

Sporadic genetic mutations can mutate independently of family history.

 

If PIK3CA mutations are latent, they can lead to cancer proliferation as well as resistance to endocrine therapy and poor prognosis.

 

In a three-phase SOLAR-1 study conducted by Novartis, Piqray and Fulvestrant combined therapy approximately doubled the primary evaluation variable, Progressive Survival Period (PFS).

 

The median survival period for the combined therapy group was 11.0 months and 5.7 months for the sole therapy group.

 

Overall response rate (ORR), an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to Fulvestrant in patients with a PIK3CA mutation, (ORR= 35.7% vs 16.2% for fulvestrant alone, p=0.0002).

 

There was a clinically relevant improvement in OS of eight months for patients with a PIK3CA mutation taking Piqray plus Fulvestrant compared to Fulvestrant alone (median OS 39.3 months vs.

 

31.4 months).

 

This difference did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer.

 

In terms of safety, most of them were mildly reactive, which can be managed by dose control, and the rate that led to discontinuation of medication was similar to that of the sole therapy group.

 

However, during the administration period, patients may experience severe skin irritation due to drugs, which requires management.

 

The MFDS recommended that Piqray be stopped if the skin is more than 30% toxic to the body surface.

 

As the first PIK3CA-targeted treatment that can meet unmet demand has crossed the licensing threshold, attention is expected to be focused on whether to be reimbursed for combined therapy.