/2022 ASCO Express - Ribociclib brings new evidence of overall survival benefit to breast cancer patients

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2022 ASCO Express - Ribociclib brings new evidence of overall survival benefit to breast cancer patients

Novartis China

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Ribociclib is currently the only CDK4/6 inhibitor to have observed a consistent overall survival (OS) benefit in all three phase III clinical trials, with the longest median OS value to date in HR+/HER2- metastatic breast cancer 1-10
After the dose of Ribociclib is reduced as required, Ribociclib combined with letrozole can still maintain OS benefit in the first-line treatment of postmenopausal women with HR+/HER2 metastatic breast cancer 11
Match-adjusted indirect comparison analysis showed that patients' quality of life was better when ribociclib plus AI was used as first-line treatment compared with abeciclib plus aromatase inhibitor (AI) 12

Novartis recently announced new overall survival (OS) and quality of life (QoL) analysis data for Ribociclib combined with endocrine therapy in patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

In a new exploratory analysis of data from the phase III MONALEESA-2 study, ribociclib plus letrozole sustained OS benefit in the first-line treatment of postmenopausal patients with HR+/HER2- metastatic breast cancer, including those who required ribociclib dose adjustment (Abstract #1017). In this analysis, a median OS of 66.0 months was observed in patients who had at least one dose reduction of ribociclib from a starting dose of 600 mg, compared with 60.6 months in patients who did not have a dose reduction (95% CI: 57.6 to 75.7 and 42.5 to 79.2, respectively). In addition, OS benefit was observed in all patient subgroups treated with ribociclib plus letrozole 11.

"Ribociclib is currently the only CDK4/6 inhibitor to demonstrate a statistically significant overall survival benefit in all of its Phase III clinical studies," said Reshema Kemps-Polanco, executive vice president, U.S. Oncology, Novartis Innovative Medicines. "Overall survival is the ultimate goal of oncology clinical trials and what patients want: to live longer and live better. We are excited about Ribociclib's quality-of-life data and in HR Extremely proud of the longest median overall survival in +/HER2- metastatic breast cancer.”

The MAIC* (Match-Adjusted Indirect Comparison) study demonstrates that ribociclib plus an aromatase inhibitor improves symptom-related quality of life, indirectly compared with abeciclib plus an aromatase inhibitor, in the first-line treatment of postmenopausal patients with HR+/HER2- metastatic breast cancer (Abstract #1015). MAIC study results support that ribociclib combined with an aromatase inhibitor is superior in time to sustained deterioration (TTSD), including loss of appetite, diarrhea, fatigue and arm symptoms.

“As a clinician and clinical researcher who treats patients with metastatic breast cancer, I have always strived to find therapies that would give patients longer survival while maintaining their quality of life,” said Hope S. Rugo, M.D., professor of medicine and director of Breast Oncology and Clinical Trials Education and Clinical Trials Education at the UC Helen Diller Family Comprehensive Cancer Center. “Our indirect comparison of ribociclib plus an aromatase inhibitor helped us gain an initial understanding of symptoms that may impact quality of life and the differences between treatment options.”

*MAIC is a method used to compare the effectiveness of treatments after adjusting for differences in patient populations when head-to-head trials are not available.

About Ribociclib

Ribociclib is currently the only CDK4/6 inhibitor that has been proven to have an overall survival benefit in all three phase III clinical studies 1 - 9 , and is recognized by the National Comprehensive Cancer Network (NCCN) guidelines as the only CDK4/6 inhibitor that has an overall survival benefit in the first-line treatment of HR + / HER2 - metastatic breast cancer 13 . In addition, according to the ESMO Clinical Benefit Scale (MCBS), Ribociclib has the highest score among current CDK4/6 inhibitors, and its score for the first-line treatment of premenopausal HR + / HER2 - metastatic breast cancer patients reaches a full score of 5 points 14 . In addition, the score of Ribociclib combined with letrozole or fulvestrant in the first-line treatment of postmenopausal patients with HR + / HER2 - metastatic breast cancer was 4 points 15 .

Ribociclib has been approved in more than 95 countries around the world, including the U.S. Food and Drug Administration (FDA) and the European Commission, in combination with aromatase inhibitors or fulvestrant for the treatment of women with HR+/HER2- advanced or metastatic breast cancer, as initial endocrine-based therapy or after disease progression during endocrine therapy 10,16 . The FDA approved Ribociclib in combination with fulvestrant as initial treatment for men on endocrine therapy or after disease progression after endocrine therapy 16 .

Novartis treats breast cancer with scientific excellence, collaboration and a passion for patients. We have taken a bold approach to research, including patient populations often overlooked in clinical trials, identifying new pathways or mutations that may play a role in disease progression, and developing therapies that not only maintain but improve patients' quality of life. Over the past 30 years and today, our mission has been to provide treatments that improve and extend the lives of patients with metastatic breast cancer.