Kisqali Phase 3 Trial Meets Primary Endpoint for Patients With Early Breast Cancer


Ribociclib plus endocrine therapy demonstrates a reduction in the risk of disease recurrence in patients with HR+/HER2- early breast cancer.

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Ribociclib (Kisqali) from Novartis plus endocrine therapy met its primary endpoint of invasive disease-free survival in a broad population of individuals with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer and at risk of recurrence, according to positive topline results from a phase 3 trial.

The Independent Data Monitoring Committee has recommended stopping the NATALEE (NCT03701334) trial due to the primary endpoint being met.

“While most patients are diagnosed and treated early with the aim to cure breast cancer, the risk of cancer returning, often as metastatic disease, peaks within 3 years after diagnosis, but never goes away completely,” Dennis Slamon, MD, director of clinical/translational research at the University of California of Los Angeles, said in the statement.

“There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life,” he said. “The NATALEE trial, where ribociclib was given for 3 years plus [endocrine therapy], was designed with these unmet needs in mind, and it is extremely encouraging that this study met its primary endpoint.”

Ribociclib and endocrine therapy significantly reduced the risk of disease recurrence compared with the standard adjuvant endocrine therapy alone. Investigators also found that it had consistent benefits for individuals with stage 2 and 3 early breast cancer, regardless of nodal involvement.

Because of the study protocol, patient follow-up will continue to evaluate long-term outcomes, which will include overall survival (OS).

The NATALEE trial was conducted in collaboration with Translational Research in Oncology. The secondary endpoints of the trial included OS, quality of life, and safety. Investigators explored the lower starting dose of 400 mg of ribociclib than the dose approved for treatment in metastatic breast cancer in the 600-mg dosage.

“The positive topline results from NATALEE represent a major milestone in our ambition to expand the benefits of [ribociclib] to patients with earlier stages of breast cancer, building on the heritage of this effective treatment in HR+/HER2- metastatic breast cancer,” Shreeram Aradhye, MD, president of Global Drug Development and chief medical officer at Novartis, said in a statement.

“These data have the potential to be paradigm-shifting for patients at risk of recurrence, including those with no nodal involvement, who have limited well-tolerated options to prevent recurrence. Our teams are working on submissions to health authorities around the world with the hope to bring [ribociclib] to many more patients diagnosed with breast cancer,” Aradhye said.

The findings built on the legacy of ribociclib in metastatic breast cancer, where it has consistently demonstrated an OS benefit while improving or preserving quality of life across 3 phase 3 trials.

Updates to the NCCN Clinical Practice Guidelines in Oncology for breast cancer, which were released in January 2023, recommended ribociclib as the only category 1 preferred CDK4/6 inhibitor for the first-line treatment of individuals with HR+/HER2- metastatic breast cancer when combined with an aromatase inhibitor.


Novartis Kisqali phase III NATALEE trial meets primary endpoint at interim analysis demonstrating clinically meaningful benefit in broad population of patients with early breast cancer. News release. Novartis. March 27, 2023. Accessed March 27, 2023.

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