Novartis Announces Phase III NATALEE Trial Success of Ribociclib as Adjuvant Therapy in Early Breast Cancer

On March 27, Novartis announced the interim analysis data of the Phase III NATALEE study on ribociclib (brand name: Kisqali), a CDK4/6 inhibitor, in combination with endocrine therapy (ET) for adjuvant treatment of HR+/HER2- early breast cancer patients (EBC). The study met its primary endpoint of invasive disease-free survival (iDFS), and the Independent Data Monitoring Committee recommended stopping the trial early.

NATALEE is a randomized, open-label global multicenter Phase III clinical trial designed to evaluate the efficacy and safety of ribociclib combined with ET as adjuvant therapy for patients with HR+/HER2- early breast cancer. The study enrolled 5,100 patients with Stage II or III EBC who are at risk of recurrence, randomly assigned to receive either ribociclib (400 mg/day) + ET or ET alone.

Results Show Trial Met Primary Endpoint of iDFS. Compared with ET alone, ribociclib plus ET significantly reduced the risk of disease recurrence in patients, consistently benefiting those with stage II or III EBC regardless of lymph node involvement. Specific data will be presented at an upcoming medical conference. According to the NATALEE study protocol, Novartis will continue to evaluate long-term outcomes of patient follow-up, including overall survival (OS).

Ribociclib is a CDK4/6 inhibitor that blocks the proliferation of cancer cells by preventing tumor cells from transitioning from the G1 phase to the S phase. In March 2017, this product was approved for the first time in the United States. To date, its FDA-approved indications include: in combination with an aromatase inhibitor as initial endocrine therapy for HR+/HER2- locally advanced or metastatic cancer in adult patients; in combination with fulvestrant as initial endocrine therapy or for disease progression after failure of initial endocrine therapy in postmenopausal women or male patients with HR+/HER2- advanced or metastatic cancer.

Currently, there are five CDK4/6 inhibitors available on the global market, but only abemaciclib has been approved for HR+/HER2- early breast cancer. In terms of market performance, except for Hengrui's Airekang (dalpiciclib, sales data not disclosed), the sales figures of the other four CDK4/6 inhibitors are shown in the chart below.

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