Kisqali Plus Endocrine Therapy Reduces Breast Cancer Recurrence by 28.5% in Phase 3 Trial
Key Insights
Novartis' Kisqali, combined with endocrine therapy (ET), significantly reduced the risk of breast cancer (search) recurrence by 28.5% in patients with stage II or III HR+/HER2- early breast cancer (search) compared to ET alone.
The Phase 3 clinical trial data showed a sustained benefit beyond the three-year treatment period, offering a potential new treatment option for patients at risk of recurrence.
Novartis has submitted these results to the FDA and EMA, with an FDA decision on approval for this treatment anticipated this quarter, marking a potential advancement in breast cancer (search) therapy.
Novartis' Kisqali (ribociclib), when combined with endocrine therapy (ET), has demonstrated a significant reduction in the risk of recurrence for patients with stage II or III HR+/HER2- early breast cancer (search). The updated analysis of the Phase 3 clinical trial revealed a 28.5% reduction in recurrence risk compared to ET alone, showcasing a deepening benefit beyond the three-year treatment period.
Trial investigator Dr. Peter Fasching emphasized the importance of these findings, noting that patients with this form of breast cancer (search) face a substantial risk of the cancer returning as metastatic disease. Clinicians have been actively seeking new ways to address this risk, and the results of this trial offer a promising new treatment option for a broad range of patients at risk of recurrence.
Regulatory Submissions and Anticipated Approval
Novartis has already submitted the results of the Phase 3 clinical trial to both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company anticipates a decision from the FDA regarding approval of the treatment this quarter. This regulatory action could potentially provide a new standard of care for patients with HR+/HER2- early breast cancer (search).
Impact on Novartis
The positive news from the Kisqali trial has had a noticeable impact on Novartis' stock. Novartis ADRs experienced a rise following the announcement of the trial results, reflecting investor confidence in the potential of Kisqali to improve outcomes for breast cancer (search) patients.