On September 17, 2024, the US Food and Drug Administration (FDA) granted approval for Novartis’s Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of individuals with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.

According to the Centers for Disease Control (CDC), based on the most recent data available, in the United States (US) in 2021, 272,454 new cancer cases were reported in females, and in 2022, 42,211 females died from cancer. Approximately 90% of cancer cases in the US are diagnosed early (stages I-III).

In response to the urgent need for effective treatment options, we will be analyzing the findings of the NATALEE Phase III trial. The results of this trial have demonstrated that Kisqali, when taken as a once-daily oral dose of 400 mg (two 200 mg tablets) for three weeks, followed by one week off treatment, in combination with four weeks of any AI, is a promising treatment option. Patients are advised to continue taking Kisqali for a duration of three years.

The NATALEE trial has shown that Kisqali at the 400 mg dose is well tolerated, with discontinuations primarily due to asymptomatic laboratory findings. Adverse events (AEs) of particular interest in the Kisqali + ET arm of the NATALEE trial include neutropenia (62.5%, 44.3%), liver-related AEs (26.4%, 8.6%), QT interval prolongation (5.3%, 1.0%), and interstitial lung disease/pneumonitis (1.5%, 0.0%).

Below is a brief overview of the study:

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/​HER2- Early Breast Cancer (NATALEE)

Study Details | Source

  • Sponsor: Novartis Pharmaceuticals
  • A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC).
    • The trial will include pre and postmenopausal women and men with HR-positive, HER2-negative EBC, with an Anatomic Stage Group III, IIB or a subset of Stage IIA cases, after adequate surgical resection, radiotherapy (if indicated), adjuvant or neoadjuvant chemotherapy (if indicated), and who are deemed to be eligible for adjuvant ET for at least 60 months of duration.
  • Approximately 5,000 patients will be randomized (using an Interactive Response Technology system [IRT]) into two treatment arms in a 1:1 ratio.
  • The trial will include screening, treatment, and follow up phases.
  • Interventions: DRUG: Ribociclib and OTHER: Endocrine Therapy
  • Primary Outcomes Measures:
    • Invasive Disease-Free Survival (iDFS), iDFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator.
      • iDFS is defined as time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin)., Up to approximately 91 months

The approval of Kisqali in combination with an AI for the adjuvant treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer represents a potential breakthrough in the field of oncology, offering new hope to individuals at high risk of cancer recurrence. This milestone highlights the critical role of ongoing research and innovation in the battle against cancer.

The question remains: will the results of this trial influence future guidelines or clinical practice? Your insights are valuable to us, and we encourage you to share your thoughts on this matter. Be sure to sign up for alerts to stay informed about the latest published guidelines and articles.

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