3rd PARPi Talzenna may be prescribed at hospitals in Korea

Lands in general hospitals in Korea

Passes drug committees of NCC, St.Mary’s Hospital, etc.

Demonstrates efficacy in EMBRACA trial...adds treatment option

Korea’s third PARP inhibitor, ‘Talzenna’ can now be prescribed at general hospitals in Korea.

 

According to industry sources, Pfizer Korea’s breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) treatment ‘Talzenna (talazoparib)' passed the drug committee reviews of various medical institutions in Korea, including the National Cancer Center St.

 

Mary’s Hospital and Yeouido St.

 

Mary's Hospital.

 

Talzenna was approved in Korea in July 2020 as monotherapy for the treatment of adult patients with germline BRCA mutations who have HER2-negative locally advanced or metastatic breast cancer with previous treatment experience.

 

Afterward, the company applied for reimbursement, and the agenda was selected for review by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in November of the same year but was unable to pass CDDC deliberations, and no progress had been made since.

 

The health authorities are known to have been expressing concerns about reimbursing PARP inhibitors like Talzenna in breast cancer due to their broad indication in the disease.

 

AstraZeneca’s Lynparza was the first PARP inhibitor to receive reimbursement in Korea.

 

Lynparza was listed for reimbursement in October 2017 and was applied the Expenditure Cap type of the Risk Sharing Agreement (RSA) through the pharmacoeconomic evaluation exemption system.

 

Listing of Takeda’s ‘Zejula’ followed in December 2019.

 

The drug may be prescribed as maintenance monotherapy for adult patients with platinum-sensitive recurrent ovarian cancer who are in complete or partial response to platinum-based chemotherapy.

 

However, its first reimbursement was only approved for approved the BRCA-positive indication.

 

However, both drugs are experiencing difficulty extending reimbursement to breast cancer.

 

Meanwhile, Talzenna’s efficacy was demonstrated through the large-scale, open-label, randomized, international Phase III trial, EMBRACA.

 

The trial compared the efficacy of Talzenna monotherapy versus chemotherapy of the investigator’s choice in patients with gBRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease.

 

Results showed that the median progression-free survival (mPFS), the primary efficacy endpoint, was 8.6 months for the Talzenna monotherapy arm, which was a significant improvement compared with the 5.6 months in the chemotherapy arm.

 

Also, the risk of disease progression or death was 46% lower in the Talzenna monotherapy arm compared to the chemotherapy arm.

 

Such significant improvement in PFS in patients treated with Talzenna was consistently observed across major patient subgroups, which were defined by the number of prior cytotoxic regimens, hormone receptor status (HR+ or TNBC), and history of CNS metastases.

 

Also, the secondary endpoint, objective response rate (ORR), was 62.6% for the Talzenna monotherapy arm, which was more than double the 27.2% achieved in the chemotherapy arm.