Ribociclib Can Add Almost 1 Year to Overall Survival for Patients With Aggressive Form of Breast Cancer


Ribociclib with endocrine therapy was found to increase the median overall survival of patients with HR+/HER2- advanced breast cancer with visceral metastases to nearly 5 years.

Ribociclib (Kisqali; Novartis) was found to add nearly 1 year to overall survival (OS) in patients with aggressive hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (aBC).

In a pooled exploratory analysis of the MONALEESA phase 3 program presented at the 2022 European Society of Medical Oncology Congress (ESMO), researchers found that first-line treatment with ribociclib and endocrine therapy increased the median OS by 10.6 months, compared to endocrine therapy alone.

“Patients who have visceral metastases typically have a worse prognosis and often demonstrate resistance to treatment, so as a clinician it is encouraging to see significant survival benefit with ribociclib in the first-line setting in patients with more aggressive disease,” said Denise A. Yardley, MD, senior investigator, Breast Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, in a press release.

Ribociclib, a CDK4/6 inhibitor, is the only inhibitor that was found to benefit the OS of patients with HR+/HER2- aBC in all its phase 3 trials. National Comprehensive Cancer Network (NCCN) guidelines also recognize ribociclib as the only CDK4/6 inhibitor to benefit OS in patients with HR+/HER2- aBC.

The subgroup of patients with this aggressive form of aBC may have visceral metastases on the liver. Compared to endocrine therapy as a sole first-line treatment, ribociclib plus endocrine therapy increased the median OS from 38.1 months to 44.2 months.

Further, among patients who have 3 or more organs with visceral metastases, first-line treatment with ribociclib and endocrine therapy increased the median OS by 8.4 months compared to endocrine therapy alone, with the median OS rising from 49.3 months to 57.7 months.

According to Magnitude of Clinical Benefit Scale, which was created by ESMO, ribociclib had the highest ratings out of every CDK4/6 inhibitor on the scale.

“Ribociclib is the only CDK4/6 inhibitor to show a consistent overall survival benefit in combination with endocrine therapy, while also maintaining quality of life across the phase 3 program,” Yardley said in the press release.

Ribociclib, combined with an aromatase inhibitor or fulvestrant, is approved by the FDA as a first-line endocrine-based therapy for HR+/HER2- advanced or metastatic breast cancer. It has also been approved in more than 95 countries worldwide.

“The goal for advanced breast cancer treatment is to help people live longer, and we are proud that Kisqali continues to deliver a significant survival benefit while also maintaining quality of life, even for those with harder-to-treat disease,” said Jeff Legos, executive vice president, global head of Oncology and Hematology at Novartis, in the press release. “We are committed to demonstrating what makes Kisqali a unique CDK4/6 inhibitor, thus providing patients and oncologists confidence in this therapeutic option.”


Novartis. Novartis Kisqali® adds one more year of survival benefit for broadest set of patients, including those with aggressive HR+/HER2- advanced breast cancer. Novartis website. September 9, 2022. Accessed on September 9, 2022. https://www.novartis.com/news/media-releases/novartis-kisqali-adds-one-more-year-survival-benefit-broadest-set-patients-including-those-aggressive-hrher2-advanced-breast-cancer

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