First PIK3CA-targeting ‘Piqray’ lands in general hospitals

Passes DC reviews of tertiary hospitals including SMC and AMC

Demonstrated PFS improvement in clinical trial…reimbursement key for the results to be implemented in practice

‘Piqray,’ the first targeted anticancer drug that targets the PIK3CA gene, may now be prescribed at general hospitals.

 

According to industry sources, Novartis Korea’s ‘Piqray (alpelisib)’ passed the drug committee (DC) reviews of 2 of the ‘Big 5’ hospitals in Korea - the Seoul Samsung Medical Center, and Seoul Asan Medical Center.

 

Piqray, which was approved in Korea in May last year, is a PIK3Caα inhibitor that blocks the overactivation of the PI3K pathway by inhibiting the overactivation of PI3K-α that is caused by PIK3CA mutation.

 

This targeted therapy is prescribed in combination with ‘Faslodex (fulvestrant)’ for patients with HR-positive/ HER2 negative metastatic or advanced breast cancer who have progressed on or after prior therapies.

 

However, as the drug is yet to be reimbursed, it is expected that some time would be needed for its active prescription even after it lands in hospitals.

 

The efficacy of Piqray was demonstrated in the SOLAR-1 trial that studied 572 men and postmenopausal women with HR-positive, HER2-negative, advanced, or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor.

 

Study results showed that the median progression-free survival improved to 11 months in patients with a PIK3CA mutation who used Piqray in combination with Faslodex, compared with the median PFPS of 5.7 months in those who used Faslodex alone.

 

The objective response rate (ORR) that shows the proportion of patients whose tumor size had reduced by 30% or more was 35.7% in the combination therapy (Piqray+Faslodex) group, which was over a twofold increase compared to the 16.2% in the Faslodex monotherapy group.

 

The secondary endpoint, overall survival (OS) in the PIK3CA-mutated cancer group, was 39.3 months in the combination therapy group.

 

Although this was 8 months longer than that of 31.4 months in the monotherapy group, the results were not statistically significant.

 

Joo-Hyuk Sohn, professor of Medical Oncology at Sinchon Severance Hospital, said, “Piqray in combination with fulvestrant is recommended as Category 1 in the NCCN guidelines for breast cancer patients with a PIK3CA mutation.

 

The introduction of this treatment option is raising hope of overcoming resistance to endocrine therapy”