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Novartis Kisqali® Reduced the Risk of Cancer Recurrence While Maintaining Quality of Life

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Novartis presents new patient-reported outcomes (PRO) data from the Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Virtual Plenary. The data show that a broad population of patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) maintained health-related quality of life (HRQoL) during treatment with Kisqali plus endocrine therapy (ET)1.

“Treatment in early breast cancer is physically and emotionally arduous, and afterwards people diagnosed with EBC struggle to balance the worry of their cancer returning with the burden of managing adjuvant treatment,” said Dr. Peter A. Fasching, Professor of Gynecology and Obstetrics Translational Medicine, at the University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. “The patient-reported outcomes from NATALEE reinforce Kisqali as a potential adjuvant option that reduces the risk of cancer returning without compromising patients’ well-being, mental health or physical abilities.”

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Patients treated with Kisqali plus ET for up to three years maintained their physical functioning and global health scores when compared to both their baseline scores and to patients treated with ET alone, demonstrating that patients maintained their overall HRQoL when treated with adjuvant Kisqali1.

“No patient should have to choose between maintaining their quality of life and doing everything they can to remain cancer free,” said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology Development at Novartis. “These patient-reported outcomes add to the wealth of efficacy and tolerability data from the NATALEE trial suggesting Kisqali is a potential adjuvant treatment of choice for a broad range of patients with HR+/HER2- EBC, including those with node-negative disease. Kisqali could enable patients with EBC to live well with greater peace of mind.”

Further analysis of the NATALEE trial is ongoing, and additional data will be shared at upcoming medical meetings.


NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as adjuvant treatment versus ET alone in patients with HR+/HER2- EBC, being conducted in collaboration with TRIO2. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable2. The primary endpoint of NATALEE is iDFS as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria2. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial2.

Results showed Kisqali plus ET, compared to ET alone, lowered the risk of cancer recurrence by 25.2% (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014), along with consistent clinically meaningful iDFS benefit across key pre-specified subgroups: AJCC Tumor Stage II (HR=0.761; 95% CI: 0.525, 1.103), AJCC Tumor Stage III (HR=0.740; 95% CI: 0.592, 0.925), node-negative disease (HR=0.630; 95% CI: 0.341, 1.165), node-positive disease (HR=0.771; 95% CI: 0.630, 0.944), pre-menopausal women and men (HR=0.722; 95% CI: 0.530, 0.983), post-menopausal women (HR=0.781; 95% CI: 0.613, 0.997)2. Kisqali data across all secondary efficacy endpoints was also consistent, including DDFS (26% risk reduction) and RFS (28% risk reduction), with a trend for improvement in OS (HR=0.759; 95% CI: 0.539, 1.068)*2.

Median study duration of follow up was 34 months (range 21-48 months) with clinical benefits observed after approximately two years2. NATALEE explored a lower starting dose (400 mg) of Kisqali than the dose approved for treatment in metastatic breast cancer (MBC) (600 mg) with the goal to minimize disruptions to patient quality of life without compromising efficacy. The safety profile of Kisqali at 400 mg was favorable with low rates of symptomatic AEs and limited need for dose modifications when administered up to three years2. The most frequently reported AEs of special interest (grade 3 or higher) were neutropenia (43.8%) and liver-related AEs (e.g. elevated transaminases) (8.3%)2.