ASCO: Novartis presents positive data from landmark Phase III NATALEE in EBC

Swiss pharma giant Novartis (NOVN: VX) kicked off its 2023 American Society of Clinical Oncology (ASCO) presentations today, with much anticipated positive primary endpoint data from the pivotal Phase III NATALEE trial on Kisqali (ribociclib) in early breast cancer (EBC).

These show  that Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014) along with a consistent, clinically-meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups.

Kisqali, a CDK4/6 inhibitor, is the first and only to show consistent, clinically-meaningful results across a broad population of early breast cancer (EBC) patients, said Novartis, which now plans to submit these Phase III data to regulatory authorities in the USA and Europe before end of year.