Results from an updated analysis of the pivotal phase III NATALEE trial of Ribociclib ( Kisqali ) that underscore the extended efficacy beyond the duration of treatment in combination with endocrine therapy (ET) were presented.
Results showed a sustained reduction in distant recurrence of 28.5% (hazrd ratio, HR=0.715; 95% CI 0.604-0.847; nominal P less than 0.0001), compared to endocrine therapy alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC).

Reduction in distant recurrence, known as distant disease-free survival (DDFS), is a decrease in the rate of cancer returning and spreading to other organs. The distant disease-free survival with Kisqali was consistent across all pre-specified patient subgroups, including those with node-negative (N0) disease.

Safety remains consistent with previous reports, and no new safety signals were identified. Adverse events of special interest (grade 3 or higher) were neutropenia (44.4%), liver-related adverse events (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%).

Real-world evidence has highlighted the relatively high incidence of distant recurrences within 5 years despite endocrine therapy monotherapy for patients at high-risk, regardless of nodal involvement.

NATALEE study

NATALEE is a global phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Ribociclib with endocrine therapy as an investigational adjuvant treatment versus endocrine therapy alone in patients with stage II and III HR+/HER2- early breast cancer. The adjuvant endocrine therapy in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; Anastrozole or Letrozole) and Goserelin if applicable.
The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by STEEP ( Standardized Definitions for Efficacy End Points ) criteria.
A total of 5,101 adult patients with HR+/HER2- early breast cancer across 20 countries were randomized in the trial.

Ribociclib

Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. ( Xagena_2024 )

Source: 2024 San Antonio Breast Cancer Symposium ( SABCS )

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