Kiscali (ingredient name ribociclib) proved the longest overall survival in a phase 3 clinical trial for metastatic breast cancer.
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Novartis Korea announced the results of long-term follow-up for more than 4 years of the Kiscali Phase 3 clinical trial MONALEESA-7 at the San Antonio Breast Cancer Symposium (SABCS 2020), which was held online from the 8th to the 11th. did.
After 53.5 months of follow-up, in patients with hormone receptor positive, human epithelial growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer, the median total survival time of the Kiscali/endocrine therapy group was 58.7 months, 48.0 of the endocrine therapy alone group. It was 10.7 months superior to the month.
The risk of death in the Kiscali combination group decreased by 24% compared to the single group, and the combination group delayed the time of chemotherapy by 50.9 months.
Novartis explained that the safety profile of Kiscali was similar to the results of previous studies, demonstrating its effectiveness in patients with metastatic breast cancer before menopause even when administered for a long time.
Professor Lim Seok-ah of the Department of Hematology and Oncology at Seoul National University Hospital, who conducted the MONALEESA-7 clinical study, said, “This result is meaningful that we have demonstrated the longest overall survival in the domestic and foreign metastatic breast cancer phase 3 clinical trials.” He said, “As it proved the ultimate goal of prolonging the survival period, it is necessary to improve the salary standard to provide the therapeutic effect of Kiscali for metastatic breast cancer patients.”
Shin Soo-hee, general manager of Novartis’ anticancer drug division, said, “We are working hard to provide the best treatment effect to patients. We will do our best to supply innovative treatments so that domestic breast cancer patients can dream of their long-term hope.”
Meanwhile, Kiscali was approved by the Ministry of Food and Drug Safety in October last year as a treatment for advanced HR+/HER2- or metastatic breast cancer before and after menopause. On November 1st, health insurance benefits were applied to HR+/HER2- metastatic breast cancer patients regardless of menopause.
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