Novartis’ advanced breast cancer drug Kisqali® (ribociclib) is first cancer treatment recommended by NICE under updated cancer appraisal process*
Nov 16, 2017
Advanced breast cancer is an incurable disease, responsible for 90 per cent of all breast cancer-related deaths1
Ribociclib in combination with an aromatase inhibitor is a new and effective treatment option for women in England and Wales with the most common form of advanced breast cancer, giving them the possibility of living on average two years without their disease progressing2
Ribociclib is taken orally once daily, allowing women with advanced breast cancer to take their treatment at home, with or without food3
*Kisqali is the first cancer treatment recommended by NICE within 90 days of marketing authorisation through the updated review process
Camberley, UK, November 16, 2017 – Novartis today announced Kisqali® (ribociclib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer.
Postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer will have access to ribociclib, a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor, as a first-line treatment in combination with an aromatase inhibitor. Ribociclib will be routinely available on the NHS with immediate effect.
“This is a breakthrough moment for the advanced breast cancer community in England and Wales. The combination of ribociclib with an aromatase inhibitor offers women the very real possibility of two years of control of their breast cancer without the need for chemotherapy,” said Dr Alistair Ring, Consultant Medical Oncologist at The Royal Marsden, London. “I see first-hand the devastating impact of this challenging disease on women and their families, so it is really positive news that we can now access ribociclib as a first line treatment.”
In the UK, around 55,000 women are diagnosed with breast cancer each year4. Thirty per cent of women with earlier stages of breast cancer will develop advanced disease5, which is responsible for 90% of all breast cancer-related deaths1. Eighty-five per cent of women diagnosed with advanced breast cancer will not live longer than five years6.
“With the NICE recommendation of ribociclib, postmenopausal women with advanced breast cancer now have a treatment they can fit into their everyday lives,” said Prof Mark Beresford, Co-Chair of the UK Breast Cancer Group (UKBCG), which represents Clinical and Medical Oncologists treating breast cancer in the UK. “This marks a significant milestone in the care we can offer not just through halting disease progression, but also the convenience of taking a daily pill at home. Anything to help women with this incurable disease maintain their quality of life is an essential development.”
“The impact caused by an advanced breast cancer diagnosis can put women and their loved ones through immense emotional strain. Up to 8,300 women a year in England and Wales could now benefit from this new and effective treatment option, allowing them to live longer without their disease worsening, maintain their quality of life and enjoy special moments with their children, family and friends,” said Barak Palatchi, General Manager of Novartis Oncology UK & Ireland. “Under the new NICE process, this is the first time a cancer medicine has been funded so soon after being licensed – showing that the system can work to bring innovation earlier, to benefit patients and the NHS.”
Ribociclib can be used in combination with letrozole, anastrozole or exemestane - giving oncologists the discretion to select the therapy they believe is most appropriate for each individual patient. The active ingredient for ribociclib is manufactured in the UK at Novartis’ Grimsby site.
The NICE recommendation follows EU licensing by the European Commission in August, which was based on the superior efficacy and an acceptable safety profile of ribociclib plus letrozole versus placebo plus letrozole in the pivotal Phase III MONALEESA-2 trial. The trial enrolled 668 postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer and showed that ribociclib plus letrozole, an aromatase inhibitor, reduced the risk of progression or death by 43% over placebo plus letrozole (median PFS=25.3 months ([95% CI: 23.0-30.3]) vs. 16.0 months ([95% CI: 13.4-18.2]); HR=0.568 ([95% CI: 0.457-0.704; p<0.0001])2. More than half of patients (55%) with measurable disease taking ribociclib plus letrozole experienced a tumour size reduction of at least 30%2. Adverse events are generally manageable with stepwise dose modification, allowing most patients to remain on treatment7.
The NICE recommendation has been published in its final draft guidance. Novartis is awaiting the NICE Technology Appraisal Guidance, the final step within the NICE approval process, which is scheduled for publication in December 2017 and will be available via the NICE website.
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 uncontrollably8.
Kisqali 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. Kisqali is taken in combination with four weeks of any aromatase inhibitor.
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
About the Kisqali Clinical Trial Programme Novartis is continuing to assess Kisqali through the robust MONALEESA clinical trial program, which includes two additional Phase III trials, MONALEESA-3 (NCT02422615) and MONALEESA-7 (NCT02278120) that are evaluating Kisqali in combination with multiple endocrine therapy partners across a broad range of patients, including premenopausal women. MONALEESA-3 is evaluating Kisqali in combination with fulvestrant compared to fulvestrant alone in postmenopausal women with HR+/HER2- advanced breast cancer who have received no or a maximum of one prior endocrine therapy. MONALEESA-7 is investigating Kisqali in combination with endocrine therapy and goserelin compared to endocrine therapy and goserelin alone in premenopausal women with HR+/HER2- advanced breast cancer who have not previously received endocrine therapy. These trials are fully enrolled.
Novartis is enrolling two multi-centres, randomised, double-blind Phase III clinical trials, EarLEE-1 (NCT03078751) and EarLEE-2 (NCT03081234), to evaluate the safety and efficacy of Kisqali with endocrine therapy as adjuvant therapy in pre- and postmenopausal women who have not previously received treatment with CDK4/6 or aromatase inhibitors. EarLEE-1 will assess Kisqali with adjuvant endocrine therapy compared to adjuvant endocrine therapy alone in women with HR+/HER2- high-risk early breast cancer. EarLEE-2 will investigate Kisqali with adjuvant endocrine therapy compared to adjuvant endocrine therapy alone in women with HR+/HER2- intermediate-risk early breast cancer.
The CompLEEment study (NCT02941926) is evaluating the safety and efficacy of Kisqali plus letrozole in men and pre- or postmenopausal women with HR+/HER2- advanced breast cancer with no prior hormonal therapy for advanced disease. The open-label, multi-centres, Phase IIIb CompLEEment-1 trial is fully enrolled at 26 sites across the UK.
About Novartis in Advanced Breast Cancer For more than 25 years, Novartis has been at the forefront of driving scientific advancements for breast cancer patients and improving clinical practice in collaboration with the global community. With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease.
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 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
In the UK, Novartis develops, manufactures and markets innovative medicines, devices and diagnostic tests which help improve patient outcomes. Based on four sites across the north and south of England, 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 by manufacturing the active pharmaceutical ingredients used worldwide in many medicines. In 2016 Novartis in the UK invested almost £40million in R&D and is the largest commercial sponsor of clinical trials. For more information, please visit www.novartis.co.uk.
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).
KISQALI® (ribociclib) Summary of Product Characteristics. Camberley, United Kingdom: Novartis Europharm Limited; 2017.
Jani, W. et al. First-line ribociclib plus letrozole for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC): MONALEESA-2 safety results. J Clin Oncol 35, suppl; abstr 1047 (2017).
Hortobagyi G, Stemmer S, Burris H, et al. Ribociclib as a first-line therapy for HR-positive, advanced breast cancer. New England Journal of Medicine. 2016.