Piqray to soon be deliberated by CDDC for reimb

PIK3CA-targeting drug

Makes reattempt after narrowing the scope of reimbursement standards... listed in the UK and Canada

Mutation occurs in 40% of patients... gains attention as a viable treatment option

Whether reimbursement discussions for the PIK3CA gene-targeting anticancer drug ‘Piqray’ will make progress is gaining attention.

 

According to industry sources, Novartis Korea’s Piqray (alpelisib) is expected to be deliberated at the coming Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee meeting.

 

The drug had been unable to pass deliberations from the same committee in February last year and had refiled an application for reimbursement at the end of last year.

 

However, based on CDDC’s A8 country assessment results that were disclosed after the meeting, reimbursement standards discussed this time will be narrowed to PIK3CA mutation-positive patients whose tumor had progressed after being treated with CDK4/6 inhibitor·aromatase inhibitor combination therapy.

 

Currently, Piqray is being reimbursed in HTA countries including the UK and Canada.

 

What kind of results Piqray and its narrowed reimbursement standards will produce this time remains to be seen.

 

Piqray, which was approved in Korea in May 2021, is a PIK3Caα inhibitor that blocks the overactivation of the PI3K pathway by inhibiting the over-activation of PI3K-α caused by a mutation of a PIK3CA gene.

 

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

 

Meanwhile, the efficacy of Piqray was demonstrated in the SOLAR-1 trial, a study on 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.

 

Results showed that Piqray, when used in combination with Faslodex, improved the median PFS (Progression- Free survival) of cancer patients with the PIK3CA mutation from 5.7 months to 11 months.

 

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 group, which was over a twofold difference from the 16.2% in the monotherapy group.

 

Although the secondary endpoint, overall survival (OS) in the PIK3CA-mutated cancer group was 39.3 months in the combination therapy group, 8 months longer than the 31.4 months in the monotherapy group, the results were not statistically significant.