Novartis Announces New Data on the Treatment of HR+/HER2- Metastatic Breast Cancer by Kisqali, a CDK4/6 Inhibitor

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On December 8, Novartis announced new data on the CDK4/6 inhibitor Kisqali (ribociclib) at the 2021 San Antonio Breast Cancer Symposium (SABCS).

Extensive exploratory analysis of nearly 1,000 tumor samples showed that compared with ET treatment, Kisqali+ET combination therapy consistently provided significant OS benefits in the main intrinsic subtypes (Luminal A: n=542; HR=0.

In HR+/HER2- breast cancer, HER2 overexpression subtype is associated with ET treatment resistance and poor prognosis.

These data follow the biomarker analysis of the Monalesa trial published at the SABCS 2020 conference and published in the Journal of Clinical Oncology

The four inherent subtypes of breast cancer (Luminal A, Luminal B, HER2 overexpression, and basal-like) have significant differences in incidence, survival, and response to treatment

CDK, or Cyclin Dependent Kinase, is a key kinase involved in cell cycle regulation

Kisqali is the second CDK4/6 inhibitor approved for marketing in the world, and it has been approved in more than 95 countries

In October this year, Kisqali's marketing application was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA)

Reference source: New Kisqali® data shows consistent overall survival benefit across genomic and clinical subtypes of interest in HR+/HER2- metastatic breast cancer