#USA #Breast Cancer #Novartis #East Hanover #Kisqali

Latest Advances in Breast Cancer Treatment: The NATALEE Study

Recent findings from the Novartis Kisqali® NATALEE trial have unveiled significant advancements in the treatment of early-stage breast cancer, particularly regarding distant recurrence rates. The study highlights a durable reduction in recurrence among various patient demographics, including those with node-positive and high-risk node-negative disease.

The analysis indicates that the efficacy of Kisqali extends beyond the three-year treatment duration. Specifically, patients who underwent treatment exhibited a marked reduction in distant recurrence by 28.5% when compared to those receiving only endocrine therapy (ET). This data, disclosed at the 2024 San Antonio Breast Cancer Symposium (SABCS), signifies a pivotal moment in the ongoing battle against breast cancer.

Understanding Distant Recurrence

Distant recurrence refers to instances where cancer that has been initially treated returns and spreads to other organs, presenting a significant concern for patients recovering from early breast cancer. The NATALEE trial's findings suggest that incorporating Kisqali with endocrine therapy can significantly mitigate this risk.

Paolo Tarantino, an Advanced Fellow at Dana-Farber Cancer Institute, emphasizes that many patients retained a persistent risk of recurrence even after early diagnosis, sometimes developing into metastatic disease. The trial results offer hope for high-risk patients, including those with node-negative profiles, by demonstrating that treatment with a CDK4/6 inhibitor like Kisqali can be a vital component of a comprehensive therapeutic strategy.

Distant Disease-Free Survival (DDFS) Results

The DDFS, which measures the period in which patients remain free from distant recurrences, showed consistent improvement across all specified groups participating in the NATALEE trial.

Here are some significant statistics presented:

• - Intention-To-Treat Population: 0.715 (HR=0.715; 95% CI: 0.604-0.847)
• - Node-negative Disease: 0.696 (HR=0.696; CI: 0.403-1.204)
• - Node-positive Disease: 0.726 (HR=0.726; CI: 0.608-0.867)
• - Stage IIA: 0.396 (HR=0.396; CI: 0.218-0.720)
• - Stage IIB: 0.806 (HR=0.806; CI: 0.524-1.238)

This extensive data underscores the effectiveness of Kisqali across multiple patient subgroups, demonstrating its role as an adjuvant treatment that can help manage the risk of recurrence comprehensively.

Real-World Evidence of Efficacy

In addition to the clinical trial data, real-world analyses presented at the symposium indicate a high incidence of distant recurrences within five years for high-risk patients receiving only endocrine therapy. This highlights the necessity of incorporating effective treatments like Kisqali to enhance patient outcomes.

Jeff Legos, Executive Vice President of Global Head of Oncology Development at Novartis, noted the timely approval of Kisqali by the FDA and EMA as an essential step in evolving breast cancer treatments. With the recent NCCN Guidelines® designating it as a Category 1 preferred treatment option, it stands as a crucial advancement in clinical practice.

Safety Profile

The safety profile of Kisqali has remained consistent with prior reports, with no new safety concerns raised. However, notable adverse events (AEs) include:

• - Neutropenia (44.4%)
• - Liver-related AEs (8.6%)
• - QT interval prolongation (1.0%)

Conclusion

The outcomes presented at SABCS offer critical insights into how innovative treatments like Kisqali can significantly impact the landscape of breast cancer management. The NATALEE trial's findings not only reinforce the importance of combining Kisqali with endocrine therapy but also emphasize Novartis’ ongoing commitment to advancing breast cancer treatment. As research progresses, there is hope that more patients will experience improved survival rates and reduced recurrence risks, marking a significant step forward in the fight against breast cancer.