Eli Lilly said its anticancer drug Verzenio showed an improvement in overall survival when used with fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.
Verzenio is the first CDK (cyclin-dependent kinase) 4/6 inhibitor to show such progress, the company said.
Lilly Korea applied for the Health and Insurance Review and Assessment Service’s grant to allow the insurance coverage of Verzenio last month. The latest result is expected to support the discussion of making the combo therapy reimbursable, industry watchers said.
According to Lilly’s interim analysis on the MONARCH 2 study, Verzenio (ingredient: abemaciclib) demonstrated a statistically significant improvement in overall survival in advanced or metastatic breast cancer.
The study evaluated the combo of Verzenio and fulvestrant in patients with HR+/HER- advanced or metastatic breast cancer who were previously treated with endocrine therapy. The trial included both pre/peri- and postmenopausal women.
In the MONARCH 2 trial, Verzenio reached the primary objective by improving progression-free survival. Based on this, Lilly obtained approval for the combo of Verzenio and fulvestrant in over 50 countries.
The interim analysis was aimed to observe overall survival, the evaluation indicator for the secondary endpoint. The result showed that the combo treatment improved overall survival in a statistically significant way, compared to the monotherapy of fulvestrant. The safety profile was consistent with the existing one of Verzenio, the company said.
Lilly said it planned to submit the data to regulatory authorities and present the details at an upcoming academic meeting later this year.
Lilly Korea, which won the local nod for Verzenio in the first half, applied for insurance benefit of Verzenio to the HIRA last month.
The company applied both indications – a combo with an aromatase inhibitor as the primary endocrine therapy for postmenopausal HR+/HER2- advanced or metastatic breast cancer, and a combo with fulvestrant for HR+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy.
The first CDK 4/6 inhibitor arriving in Korea earlier was Pfizer’s Ibrance (palbociclib).
Pfizer Korea applied for insurance coverage of the drug’s combo with fulvestrant in March. However, the application has not shown much progress after the HIRA’s cancer disease review committee did not discuss it during its fifth meeting in late July.
Verzenio’s improvement of overall survival is raising hopes that the health authorities could actively discuss granting reimbursement for the combo therapy of CDK 4/6 inhibitor and fulvestrant.
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