Novartis Eagerly Awaits NICE Decision Following EU Licensing for Kisqali®▼(Ribociclib) for Women With Advanced Breast Cancer

CAMBERLEY, England, August 24, 2017 /PRNewswire/ --

• Advanced breast cancer is an incurable disease, responsible for 90 per cent of all breast cancer-related deaths^[1] 
• Ribociclib in combination with an aromatase inhibitor is a new and effective treatment option offering postmenopausal women with the most common form of advanced breast cancer the possibility of two years without their disease progressing^[2] 
• Timely access to ribociclib hangs on NICE's decision to fund via the NHS 

Novartis today announced Kisqali^® (ribociclib) has received authorisation from the European Commission for the treatment of advanced breast cancer. Ribociclib is now licensed for use in Europe as a first-line treatment in combination with an aromatase inhibitor in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.

"The availability of treatments such as ribociclib is a significant clinical advance for women living in the UK with this type of breast cancer," said Dr Mark Verrill, Consultant Medical Oncologist at the Freeman Hospital, Newcastle. "Ribociclib, which is an oral treatment that can be taken at home, slows down the progression of advanced breast cancer for an average of over two years in combination with an aromatase inhibitor in postmenopausal women. I had first-hand experience of using ribociclib in the MONALEESA-2 trial, and look forward to a swift agreement with NICE so that access is not an issue for postmenopausal women in England and Wales who could be offered this new treatment."

In the UK, around 55,000 women are diagnosed with breast cancer each year^[3]. Thirty per cent of women with earlier stages of breast cancer will develop advanced disease^[4], which is responsible for 90% of all breast cancer-related deaths^[1]. Eighty five per cent of women diagnosed with advanced breast cancer will not live longer than five years^[5].

"We are delighted to receive European marketing authorisation for ribociclib in combination with an aromatase inhibitor. This is great news for so many postmenopausal women with the most common form of advanced breast cancer as the combination has proven to significantly increase the delay in disease progression over current standard of care," said Barak Palatchi, General Manager of Novartis Oncology UK & Ireland. "The new NICE process to assess funding cancer medicines on the NHS is a welcome development and we are working closely with NICE to ensure eligible patients in England and Wales have access to ribociclib at the earliest opportunity."

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 EU licence follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was based on the superior efficacy and an acceptable safety profile of Kisqali 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 Kisqali 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 percent^[2]. Adverse events are generally manageable with simple stepwise dose modification, allowing most patients to remain on treatment^[6].

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 too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably^[7].

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-centre, Phase IIIb CompLEEment-1 trial is currently enrolling participants in 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.

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 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 119,000 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 2015 Novartis in the UK invested over £50million in R&D and is the largest commercial sponsor of clinical trials. For more information, please visit http://www.novartis.co.uk.

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References 

1. American Cancer Society. Unlocking the Mysteries of Metastasis. Available at: http://blogs.cancer.org/expertvoices/2013/01/23/unlocking-the-mysteries-of-metastasis/ [Accessed August 2017]

2. 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). 

3. Cancer Research UK [Online]. Breast cancer incidence (invasive) statistics. Available from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer#heading-Zero [Accessed July 2017].  

4. O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. October 2005, 10(suppl.): 20-29. 

5. Cancer Research UK [Online]. Breast cancer survival statistics. Available from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer#heading-Three [Accessed August 2017]. 

6. Janni, 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). 

7. 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. 

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