AstraZeneca Korea seeks Truqap reimbursement as second-line gap persists in breast cancer

AstraZeneca Korea is seeking reimbursement for its breast cancer drug Truqap (capivasertib) in Korea, arguing that patients with HR-positive, HER2-negative metastatic breast cancer still have limited options once standard first-line treatment stops working.

At a press conference in Seoul on Tuesday, Sohn Joo-hyuk, chief of the Division of Medical Oncology at Yonsei Cancer Center, said the current first-line standard for hormone receptor-positive, HER2-negative metastatic breast cancer is a CDK4/6 inhibitor -- a class of targeted drugs that helps stop cancer cells from dividing -- used in combination with endocrine therapy.

Those regimens are now used in nearly all eligible patients, he said, but many eventually see their disease progress.

Sohn Joo-hyuk, chief of the Division of Medical Oncology at Yonsei Cancer Center, at AstraZeneca Korea’s Truqap media event in Seoul on Tuesday. (Courtesy of AstraZeneca Korea)

“CDK4/6 inhibitors were a major breakthrough and very good drugs,” Sohn said. “Even so, a substantial number of patients eventually progress, and that is where we have to think seriously about the next treatment.”

Sohn said some patients remain stable for years on the drugs while maintaining their quality of life, but the treatment gap after that has become harder to ignore.

Once disease progresses after a CDK4/6 inhibitor, he said, follow-on endocrine therapy alone often provides only about two to three months of median progression-free survival, leaving a clear treatment gap before chemotherapy.

That short benefit has sharpened interest in precision treatment matched to tumor mutations. Sohn said about half of patients with HR-positive, HER2-negative breast cancer carry alterations in PIK3CA, AKT1 or PTEN, genes involved in the PI3K-AKT signaling pathway that helps cancer cells survive and grow.

He said the issue is especially important in Korea, where the proportion of premenopausal breast cancer patients is relatively high and later endocrine-based treatment options can be more limited.

“In actual clinical practice, there is still strong demand for precision treatment options that allow patients to continue therapy while maintaining quality of life,” Sohn said.

AstraZeneca Korea and Sohn pointed to Truqap as a targeted option for patients whose tumors carry those mutations. Truqap is an AKT inhibitor, meaning it blocks a key protein in that cancer-growth pathway, and is used with fulvestrant, an endocrine therapy that blocks estrogen signaling.

The company cited results from the phase 3 CAPItello-291 trial, in which Truqap plus fulvestrant extended median progression-free survival to 7.3 months from 3.1 months with fulvestrant alone in patients with PIK3CA, AKT1 or PTEN alterations. The regimen also reduced the risk of disease progression or death by 50 percent in that subgroup.

Sohn said the trial was relevant to current practice because it included many patients previously treated with CDK4/6 inhibitors. “The first-line standard has improved, but there is still a gap after that,” he said.

He added that the trial showed the period of disease control could be extended well beyond the roughly three months often seen with endocrine therapy alone in this setting.

AstraZeneca Korea said Truqap is already recommended in National Comprehensive Cancer Network and European Society for Medical Oncology guidelines for this use and is reimbursed in eight major reference countries, including the United States, Britain, Canada and Australia.

In Korea, however, the drug remains unreimbursed about two years after approval.

Kim Seung-eun, breast cancer franchise lead in AstraZeneca Korea’s oncology business, said the company filed for reimbursement in November and expects the case to be reviewed by the Health Insurance Review and Assessment Service’s cancer drug committee this month.

Sohn said Korea has gone about a decade without a reimbursed mutation-based targeted therapy in this second-line setting, leaving patients with few options once CDK4/6 inhibitor treatment fails.