Health Sciences Authority approves Novartis Kisqali® for the treatment of Stage IV metastatic breast cancer in postmenopausal women
- Kisqali (LEE011/ Ribociclib), a CDK4/6 inhibitor, in combination with letrozole, showed clinically meaningful improvement in pain and reduction in tumor size
Singapore, July 16, 2018 – The Health Sciences Authority has approved Novartis Kisqali (Ribociclib, LEE011), earlier this year as a first-line treatment option for postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. The approval follows the results of Phase III MONALEESA-2 trial which was conducted at many global sites including National Cancer Centre Singapore.
The MONALEESA-2 study demonstrated a significantly longer duration of progression-free survival by reducing risk of disease progression or death by 43% among those receiving Kisqali in combination with letrozole, compared to letrozole alone in postmenopausal women who had received no prior therapy for advanced breast cancer. As early as eight weeks after starting treatment, Kisqali was associated with an earlier and sustained tumor shrinkage and reduction in pain. 3 out of every 4 (76%) patients receiving Kisqali in combination with letrozole saw a reduction in tumor size, as compared to 67% of the patients receiving letrozole alone.
“The MONALEESA-2 study has proven that Kisqali in combination with letrozole helps to shrink the tumor more effectively, and patients may experience better relief of symptoms such as pain. This is a significant breakthrough that promises to improve the outcomes for patients with advanced breast cancer, keeping the tumour under control for longer duration than anti-hormone treatment alone” said Dr Yap Yoon Sim, Senior Consultant, National Cancer Centre Singapore, principal investigator of MONALEESA-2 study and Global Steering Committee member.
Following the approval by the US Food and Drug Administration (FDA) in March 2017, Kisqali, in combination with aromatase inhibitor was added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 1 treatment option for HR+/HER2- post postmenopausal metastatic breast cancer patients.
With this therapy approved for use in 45 countries around the world, including Singapore, the United States and European Union member states, the manufacturing plant in Novartis Asia Pacific headquarters located at Tuas Biomedical Park, in Singapore has been designated to manufacture the drug for supply worldwide.
Breakthrough therapy for patients with advanced or Stage IV metastatic breast cancer
Around the world, an estimated 250,000 women are diagnosed with advanced breast cancer each year . In Singapore, 910 Singaporean women were diagnosed between 2011 and 2015, a 32% increase from 697 Singaporean women between 2006 and 2010.
Advanced or stage IV metastatic breast cancer is the most advanced stage of breast cancer that has spread beyond the breast to other parts of the body, such as brain, bones or liver. Treatment at this stage is not curative but aims at improving quality of life and prolongation of life.
Among 9 Singaporean patients from the National Cancer Centre Singapore who were enrolled in the MONALEESA-2 study was Christina Ng, “I was diagnosed with advanced breast cancer in 2014 after a scan revealed cancerous nodules in my lungs. At the point of the diagnosis, I was experiencing excruciating pain in my underarm which rendered me immobile at times because the pain could last up to more than an hour each time it occurred. With a leap of faith, I decided to take part in the Clinical Trial in August 2014 after my doctor told me about it. The results have been very heartening. The mass at my underarm has shrunk by 90% and I no longer experience the pain. I am very grateful to have the time to do the things I enjoy and for all the moments with my husband and two children.”
With novel treatment option such as Kisqali in combination with letrozole, it enhances the effectiveness of endocrine therapy in advanced Stage IV breast cancer, and delay the development of resistance in advanced breast cancer to improve outcomes for patients.
As part of the robust MONALEESA clinical trial program, Novartis continues to assess the safety and efficacy of Kisqali plus letrozole with an expanded patient population. Approximately 60 breast cancer patients in Singapore – which includes 9 Singaporean patients from the MONALEESA-2 study – were treated with Kisqali in various clinical trials across multiple disease subtypes and study sites in Singapore.
About MONALEESA-2
For more than 30 years, Novartis has been at the forefront of driving scientific research to support patients with advanced breast cancer. MONALESSA-2 (Mammary ONcology Assessment of LEE011's Efficacy and SAfety-2) trial reaffirms the company’s commitment to continue to discover and develop innovative targeted therapies to help improve and extend the lives of women living with the disease.
MONALESSA-2 is a Phase III global registration trial that evaluates the safety and efficacy of Kisqali in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- (recurrent or metastatic breast cancer) who received no prior therapy for their advanced breast cancer.
The trial was conducted at 294 clinical trial sites globally and randomized 668 patients in a 1:1 ratio stratified by the presence of liver and/or lung metastases. Patients received Kisqali 600mg/daily for three weeks on and one week off, or placebo, in combination with letrozole 2.5mg/daily per the approved label. The primary endpoint of the trial was progression-free survival (PFS). Secondary endpoints included overall survival, overall response rate, clinical benefit rate, health-related quality of life, safety and tolerability.
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 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Kisqali was approved by the European Commission in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com
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References
I Health Sciences Authority. New Drug Approval, January 2018. Accessed May 17, 2018. Information retrieved from http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Western_Medicines/New_Drug_Approvals/2018/January.html#Kisqali
II Hortobagyi G, Stemmer S, Burris H, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole in hormone receptor-positive HER2-negative advanced breast cancer. Presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), June 4, 2017, Chicago, Illinois (abstract #1038).
III Janni, W., Alba, E., Bachelot, T. et al. First-line ribociclib plus letrozole in postmenopausal women with HR+, HER2- advanced breast cancer: Tumor response and pain reduction in phase 3 MONALEESA-2 trial. Breast Cancer Res Treat (2018). 169: 469. https://doi.org/10.1007/s10549-017-4658-x
IV NCCN Clinical Practice Guidelines in Oncology Breast Cancer Version 4.2017-February 9, 2018. Accessed on 14 Feb 2018
V Buckley N, Isherwood A. Breast Cancer. Decision Resources. March 2011:1-301.4
VI Singapore Cancer Registry Annual Registry Report 2015. National Registry of Disease Office.
https://www.nrdo.gov.sg/docs/librariesprovider3/Publications-Cancer/cancer-registry-annual-report-2015_web.pdf?sfvrsn=10. Accessed May 17, 2018
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