November 2nd, 2020

// Novartis’ MONALEESA-7 KISQALI® (ribociclib) study demonstrated statistically significant improvement in overall survival in pre- and perimenopausal women with HR+/HER2- advanced breast cancer

Novartis' MONALEESA-7 KISQALI® (ribociclib) study demonstrated statistically significant improvement in overall survival in pre- and perimenopausal women with HR+/HER2- advanced breast cancer

  • KISQALI® is the first CDK4/6 inhibitor to show statistically significant improvement in overall survival (key secondary endpoint) in advanced breast cancer in pre- and perimenopausal women.1
  • At the time of the final overall survival analysis, median overall survival was not reached in the KISQALI® arm and was 40.9 months in the placebo arm. The median duration of follow-up was 34.6 months.1
  • Advanced breast cancer is the leading cause of cancer death in women 20-59 years old.2,3 

DORVAL, QC, Nov. 2, 2020 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that statistically significant overall survival (OS) results for KISQALI® (ribociclib) in combination therapy have now been approved within the KISQALI® Product Monograph. The pivotal Phase III MONALEESA-7 trial evaluated KISQALI® with endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to placebo plus endocrine therapy, in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.1

At the time of the second (final) prespecified OS analysis, the study met its key secondary endpoint of OS, demonstrating a statistically significant improvement in OS, and was consistent for the non-steroidal aromatase inhibitor (NSAI) population and across exploratory subgroups.1

"This data with improved overall survival is very compelling for the medical community when making decisions about the optimal treatment for pre- and perimenopausal patients with advanced or metastatic breast cancer," said Dr. Karen Gelmon, Professor of Medicine, University of British Columbia and Medical Oncologist, BC Cancer.  

"Overall survival is considered a very important outcome in oncology clinical trials," said Dr. Nathaniel Bouganim, Medical Oncologist, McGill University Health Centre. "To achieve overall survival benefit in metastatic disease represents a promising advancement for patients, and the medical community looks forward to future data updates on ribociclib." 

For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body, such as the lungs, liver, bones or brain.4 It may happen before or after treatment, or it may develop from reoccurring breast cancer.5 Although there have been advancements in early detection and treatment, there is still no cure for metastatic breast cancer.

"When young women are diagnosed with metastatic breast cancer, many don't know what that means and have difficulty processing that the cancer is terminal. Once the news sinks in, they focus on living as well as they can for as long as they can," said MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer. "The new ribociclib data showing overall survival benefit in the most common type of breast cancer in young women is an exciting and significant step towards meeting the most urgent unmet need for these women."

KISQALI® is indicated in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. In pre/perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. KISQALI® is also indicated in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.1

"At Novartis, we are at the forefront of driving scientific advancements and are proud of our heritage in breast cancer. Our dedication to breast cancer is reflective of our continued development of multiple compounds within our current pipeline," said Daniel Hébert, Vice-President, Medical Affairs, Oncology, Novartis Pharmaceuticals Canada Inc. Novartis leads the industry in the discovery of new therapies and combinations, especially in HR-positive breast cancer, the most common form of the disease. "We are pleased to make yet another strong medical data announcement around KISQALI® and its potential for overall survival benefit."

KISQALI® is reimbursed in Quebec, New Brunswick, Nova Scotia, Manitoba and Saskatchewan under the respective provincial drug programs. Novartis continues to work towards securing coverage across the country. 

About KISQALI® (ribociclib)
KISQALI® is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. KISQALI® was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.  

About Novartis in Advanced Breast Cancer
Novartis tackles breast cancer with advanced science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.

About Novartis Pharmaceuticals Canada Inc. 
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2019, the company invested $51.8 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult    

About Novartis 
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at

KISQALI is a registered trademark. 


  1. KISQALI®, Product Monograph, October 6, 2020. Available at: Accessed on October 28, 2020. 
  2. Benz CC. Impact of aging on the biology of breast cancer. Crit Rev Oncol Hematol. 2008;66:65-74. 
  3. World Health Organization. Top cancer per country, estimated age-standardized mortality rates (world) in 2018, females, all ages. 2018. Available at:  Accessed on October 28, 2020. 
  4. Canadian Cancer Society. What is Metastatic Cancer? Available at: Accessed on October 28, 2020. 
  5. Canadian Breast Cancer Network. What is Metastatic Breast Cancer? Available at: Accessed on October 28, 2020. 
  6. Canadian Breast Cancer Network and Rethink Breast Cancer. Living with Metastatic Breast Cancer in Canada. Available at: Accessed on October 28, 2020.

SOURCE Novartis Pharmaceuticals Canada Inc.


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