Novartis’ Kisqali^® provides “unparalleled survival benefit” in breast cancer

According to Novartis, Kisqali^® (ribociclib) plus endocrine therapy in the first-line setting added nearly a year of additional overall survival (OS) benefit in a subgroup of patients with aggressive forms of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer (aBC).

The pooled exploratory analysis from the MONALEESA Phase III programme revealed that patients with visceral metastases, including liver metastases and multiple metastatic sites, achieved a median OS of 62.7 months when treated with Kisqali plus endocrine therapy, compared to 52.1 months for those on endocrine therapy alone. Data from the analysis was presented at the European Society of Medical Oncology (ESMO) Congress.

“Patients who have visceral metastases typically have a worse prognosis and often demonstrate resistance to treatment, so as a clinician it is encouraging to see significant survival benefit with ribociclib in the first-line setting in patients with more aggressive disease,” commented Dr Denise Yardley, Senior Investigator, Breast Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, US. “Ribociclib is the only CDK4/6 inhibitor to show a consistent overall survival benefit in combination with endocrine therapy, while also maintaining quality of life across the Phase III program.”

Those with liver metastases on Kisqali plus endocrine therapy in the first-line achieved 44.2 months median OS compared to 38.1 months for those on endocrine therapy alone. For patients with visceral metastases in three or more organs, first-line treatment with Kisqali-endocrine therapy achieved 57.7 months median OS compared to 49.3 months for those on endocrine therapy alone.

“The goal for advanced breast cancer treatment is to help people live longer, and we are proud that Kisqali continues to deliver a significant survival benefit while also maintaining quality of life, even for those with harder-to-treat disease,” commented Dr Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology at Novartis. “We are committed to demonstrating what makes Kisqali a unique CDK4/6 inhibitor, thus providing patients and oncologists confidence in this therapeutic option.”