Data Reinforce Overall Survival, Quality of Life Benefits With Ribociclib in Metastatic Breast Cancer

Novartis has announced new overall survival (OS) and quality of life analyses for ribociclib (Kisqali) combined with endocrine therapy for individuals with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer.

The new data are being presented at the 2022 American Society of Clinical Oncology Annual Meeting (Abstract #1017).

“[Ribociclib] is the only CDK4/6 inhibitor to have consistently demonstrated statistically significant overall survival across its entire phase 3 program,” Reshema Kemps-Polanco, executive vice president of US Oncology at Novartis, said in a statement. “[OS] is the ultimate goal of oncology clinical trials and what patients hope for: to live longer and to thrive. We are extremely proud of our quality of life data and that [ribociclib] has the longest median overall survival ever reported in HR+/HER2- metastatic breast cancer.”

In the new analysis of data from the phase 3 MONALEESA-2 study, ribociclib plus letrozole maintained an OS benefit for individuals who are postmenopausal with HR+/HER2- metastatic breast cancer treated in the first line, including for those who required dose modifications of ribociclib.

Investigators found that the median OS was 66 months for individuals with at least 1 dose reduction of ribociclib from the starting dose of 600 mg compared to 60.6 months in individuals who did not have a dose reduction. Further, an OS benefit was observed in all individual subgroups treated with ribociclib and letrozole.

“As a clinician and clinical researcher who treats patients with metastatic breast cancer, I always strive to find a therapy that gives patients more time while also maintaining the quality of that time,” Hope Rugo, MD, professor of medicine and director of Breast Oncology and Clinical Trials Education at the University of California San Francisco’s Helen Diller Family Comprehensive Cancer Center, said in the statement. “Our indirect comparison of ribociclib plus aromatase inhibitor gives initial insight into variations in symptoms that may impact quality of life and may vary between different treatment options.”

A matching-adjusted indirect comparison is a method used to estimate the comparative efficacy of treatment after adjusting for differences in the patient populations where head-to-head trials do not exist. A matching adjusted indirect comparison (MAIC) showed that treatment with ribociclib combined with aromatase inhibitor is associated with better symptom-related quality of life when indirectly compared to Verzenio (Eli Lilly & Company) and aromatase inhibitor in the first-line setting for individuals who are menopausal with HR+/HER2- metastatic breast cancer.

Investigators reported that the results from the MAIC favored ribociclib combined with aromatase inhibitor in time to sustained deterioration, including appetite loss, arm symptoms, diarrhea, and fatigue.

Ribociclib has been approved in more than 95 countries, including by the FDA and the European Commission, for the treatment of women with HR+/HER2- advanced or metastatic breast cancer in combination either with an aromatase inhibitor or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

Additionally, ribociclib in combination with fulvestrant is approved as initial endocrine-based therapy or following disease progression on endocrine therapy in mean by the FDA.

Reference

New CDK4/6i data at ASCO reinforce Novartis Kisqali as only drug in class with consistently proven overall survival benefit in HR+/HER2- metastatic breast cancer. Novartis. News release. June 3, 2022. Accessed June 3, 2022. https://www.novartis.com/news/media-releases/new-cdk46i-data-asco-reinforce-novartis-kisqali-only-drug-class-consistently-proven-overall-survival-benefit-hrher2-metastatic-breast-cancer