In Korea where the age of breast cancer patients is low, there is an urgent need to reimburse Ibrance-fulvestrant combination therapy to help treat premenopausal patients, an expert said here Thursday.

Breast Cancer Center Director Lee Geun-seok stresses the need to provide insurance benefits for the Ibrance-fulvestrant combination therapy in treating pre-menopausal breast cancer patients during a news conference at the Plaza Seoul, on Thursday.

Lee Geun-seok, head of the Breast Cancer Center, made these and other points while explaining the characteristics of domestic breast cancer patients and their unmet medical needs, during a news conference held by Pfizer Korea on Thursday.

“The age of breast cancer breaking out in Korea is about 40 to 50 years old,” Lee said. “This is a big difference when comparing to the average age of breast cancer onset in the U.S., which is 65 or older.”

Lee stressed that the earlier the age of cancer occurrence, the more dangerous it gets for the patient as the tumor is bigger, more aggressive and progressive, and has a higher risk of recurrence and metastasis.

“Therefore, it is important to put more focus on treating young breast cancer patients as their cases are more prevalent in Korea,” he said. “Recent development of cyclin-dependent kinase (CDK) 4/6 inhibitor has significantly improved the HR+/HER2- metastatic breast cancer treatment setting, which has had limited therapeutic options.”

However, there is still limited access to treatment for young premenopausal women, which constitute the majority of local breast cancer, Lee added.

Therefore, Lee believes that there needs to be a change to resolve the unmet medical need for young premenopausal women who have an available treatment.

The conference also pointed out that among young patients, there is a high demand for targeted therapies with fewer side effects besides chemotherapy so that they can carry out their social lives and economic activities. Due to the lack of insurance benefits, however, it is hard for medical professionals to provide such treatment.

According to the presentations at the press event, the results of PALOMA-3 clinical trial showed that HR+/HER2-metastatic breast cancer patients had a longer median progression-free survival period (mPFS) of 9.5 months when treated with an Ibrance-fulvestrant combination, compared to the placebo-fulvestrant group’s 4.6 months.

Notably, the mPFS pre-menopausal/postmenopausal women’s survival period were 9.5 months and 9.9 months in the Ibrance-fulvestrant group, more than twice longer than control groups 5.6 months and 3.9 months.

Also, in the quality of life (QoL) analysis that used the patient-reported outcome, the Ibrance combination therapy had a significantly higher global QoL score than the placebo group and delayed QoL deterioration.

The study also showed that the median time where patients saw pains worsen was eight months for Ibrance combination therapy compared to 2.8 months for the placebo group.

“In addition to improving PFS compared to conventional therapies, Ibrance contributes to improving the quality of life of patients with metastatic breast cancer and is a significant treatment option for patients who are experiencing physical and psychological difficulties during treatment,” Pfizer Korea Medical Division Director Lee Ji-sun said.

Since there is no equivalent product for pre-menopausal Korean patients right now, the company will continue to work harder to give more patients the clinical benefits of Ibrance, Lee added.

Pfizer Korea applied for reimbursement regarding the Ibrance-fulvestrant combination therapy for pre and post-menopausal HR+/HER2-metastatic breast cancer patients in March. The combination therapy is also designated as a category 1 treatment for treating post-menopausal HR + / HER2-metastatic breast cancer patients by the U.S. National Comprehensive Cancer Network and European Society for Medical Oncology.

kym@docdocdoc.co.kr

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