Novartis’ Kisqali® (ribociclib) in combination with fulvestrant receives recommendation from Scottish Medicines Consortium (SMC) for the treatment of patients with the most common form of advanced breast cancer

• Breast cancer is the most common cancer in women in Scotland, accounting for 28.8% of all cancers diagnosed.^[i]
• Kisqali (ribociclib) in combination with fulvestrant is an effective treatment option for post-menopausal women in Scotland who are living with the most common form of advanced breast cancer. 

• Advanced breast cancer is an incurable disease – the recommendation gives women the possibility of living 5 months longer without their disease progressing compared with fulvestrant alone.[ii] 

• Ribociclib in combination with fulvestrant has demonstrated positive progression free survival (PFS) of 20.5 months vs. 12.8 months for placebo plus fulvestrant. [iii]

Camberley, UK, November 11^th, 2019 – Novartis today announced that, following appraisal by the Scottish Medicines Consortium (SMC), Kisqali® (ribociclib) a CDK4/6 inhibitor, in combination with fulvestrant (an endocrine (hormone) therapy), has been made available for routine use on NHS Scotland for post-menopausal women living with the most common form of advanced breast cancer.

The treatment combination is available for women with HR+/HER2- (hormone receptor positive, human epidermal growth factor receptor-2 negative) advanced breast cancer that is locally advanced or has spread to other areas of the body (metastatic). Women who have received prior hormone therapy are also eligible to access this new treatment.

In Scotland, breast cancer accounts for 28.8% of all cancers diagnosed, with 1 in 8.5 women developing breast cancer in their lifetime.ⁱ HR+/HER2- locally advanced or metastatic breast cancer is the most common form of advanced breast cancer. For women with this incurable disease, the new treatment combination could give them the possibility of living 5 months longer without their disease worsening.[iv]

“Ribociclib in combination with fulvestrant offers better therapy for women in Scotland who are affected by this incurable disease. Potentially delaying the need for more toxic chemotherapy, it provides control of the cancer for longer, whilst maintaining quality of life than can be achieved with endocrine therapy alone.” Comments Professor David Cameron, University of Edinburgh and NHS Lothian.

The SMC decision follows the positive recommendation by The National Institute for Health and Care Excellence (NICE) in July 2019 for the same indication.[v] The recommendation is based on the positive data from the MONALEESA-3 trial. The MONALEESA-3 primary report showed that ribociclib plus fulvestrant was effective for delaying the progression of HR+/HER2- advanced breast cancer in post-menopausal patients by 20.5 months compared with 12.8 months with fulvestrant and placebo alone.ⁱⁱⁱ

A further analysis of this study recently presented at the European Society for Medical Oncology (ESMO), showed that ribociclib plus fulvestrant extended overall survival by reducing the relative risk of death by 28% vs. fulvestrant and placebo alone.^iv

 “The SMC recommendation is an important development for patients with advanced breast cancer who need additional treatment options that can maintain their quality of life, provide them with more time without disease progression and offer overall survival” said Mari Scheiffele, General Manager of Novartis Oncology UK & Ireland.

About Kisqali^® (ribociclib)

Kisqali (ribociclib) 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 rapidly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.ⁱⁱ

Ribociclib is approved for use in the UK for the treatment of women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

Ribociclib can be taken with or without food as a once-daily oral dose of 600 mg (three 200 mg tablets) for three weeks, followed by one week off treatment. Ribociclib is taken in combination with four weeks of any aromatase inhibitor, or with 500 mg of fulvestrant that should be given by intramuscular injection on Days 1, 15, 29, and once monthly thereafter. Please refer to the SmPC of fulvestrant for additional details.

Ribociclib was first approved by the European Commission (EC) 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. Ribociclib in combination with an aromatase inhibitor was approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the EC in December 2018.^iv

About MONALEESA-3

MONALEESA-3 was a randomised, double-blind, placebo-controlled, multi-centre, phase III trial in postmenopausal women with HR+/HER2- mBC who received no or only 1 prior line of endocrine therapy for advanced or metastatic disease. Patients (N=726) were stratified by the presence of liver and/or lung metastases and prior endocrine therapy for advanced or metastatic disease. Patients were randomised (2:1) to receive either ribociclib 600 mg (3 weeks on, 1 week off) and fulvestrant 500 mg (intramuscular injection on Days 1, 15, 29, and once monthly thereafter) or placebo (3 weeks on, 1 week off) and fulvestrant 500 mg (intramuscular injection on Days 1, 15, 29, and once monthly thereafter). The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QOL, and safety.

About Novartis in Advanced Breast Cancer

Novartis tackles breast cancer with superior science, collaboration and a passion for transforming patient care. 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

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 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130 000 people of nearly 150 nationalities work at Novartis around the world. Find out more at www.novartis.com.

In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk.

[i] https://www.scotpho.org.uk/health-wellbeing-and-disease/cancer-breast/data/scottish/ [Last accessed October 2019]

[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] Slamon, J et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3. Journal of Clinical Oncology 2018.

[iv] Slamon, DJ, et al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor 2–negative (HER2−) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Presented at the European Society of Medical Oncology (ESMO) Congress, September 29, 2019, Barcelona, Spain (LBA7).

[v] https://www.nice.org.uk/guidance/ta593/chapter/1-Recommendations [Accessed November 2019]