Novartis Announces Kisqali Plus Fulvestrant Extends Overall Survival by Nearly 16 Months in First-Line HR+/HER2- Advanced Breast Cancer

Today, Novartis announced that its CDK4/6 inhibitor Kisqali (ribociclib), when used in combination with fulvestrant as a first-line therapy, extended the overall survival of postmenopausal HR+/HER2- advanced or metastatic breast cancer patients by nearly 16 months compared to fulvestrant alone in a Phase 3 clinical trial. The press release noted that Kisqali is the first CDK4/6 inhibitor-fulvestrant combination to demonstrate an overall survival benefit in this first-line treatment setting.

Breast cancer is the most common type of cancer among women worldwide, with approximately 2 million patients diagnosed in 2018. Patients with advanced breast cancer include those with metastatic breast cancer and locally advanced breast cancer. Compared to patients with early-stage breast cancer, patients with advanced breast cancer have lower survival rates, with a 5-year survival rate of 85% for locally advanced cases and only 27% for metastatic breast cancer.

Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow cancer progression by inhibiting two cyclin-dependent kinases 4 and 6 (CDK4/6). When these proteins are overactivated, they can cause cancer cells to grow and divide too rapidly.

In this latest analysis, at a median follow-up time of 5 years, the median overall survival for patients in the Kisqali combination therapy group reached 67.6 months, compared to 51.8 months in the fulvestrant group. The Kisqali combination therapy reduced the risk of death by 33%. Moreover, as a first-line treatment, Kisqali combination delayed the need for subsequent chemotherapy by more than a year and a half.

"These trial results continue to demonstrate the survival benefit of ribociclib for postmenopausal patients with advanced breast cancer," said Dr. Dennis J. Slamon, director of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles. "Whether used in combination with fulvestrant or aromatase inhibitors, ribociclib provides oncologists with a CDK4/6 inhibitor that delivers consistent benefits for patients with HR+/HER2- breast cancer, regardless of their disease characteristics."

References:

[1] New Novartis data demonstrate only Kisqali® offers more life in the first-line setting for postmenopausal HR+/HER2- advanced breast cancer patients. Retrieved May 4, 2022, from https://www.novartis.com/news/media-releases/new-novartis-data-demonstrate-only-kisqali-offers-more-life-first-line-setting-postmenopausal-hrher2-advanced-breast-cancer-patients

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