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Novartis’ CDK4/6 inhibitor Kisqali® (ribociclib) shows superior median PFS in combination with endocrine therapy compared to endocrine therapy as first-line treatment in premenopausal women with advanced breast cancer

Novartis
Posted on: 07 Dec 17

·         Kisqali plus an oral endocrine partner halts disease progression for nearly two years (median Progression Free Survival (PFS) 23.8 vs 13.0 months for endocrine therapy plus goserelin and placebo) and shows a rapid response as early as eight weeks[1]

 

·         MONALEESA-7 presented as a late-breaking oral abstract at the 2017 San Antonio Breast Cancer Symposium (SABCS)[1]

 

·         Kisqali is the only CDK4/6 inhibitor to show efficacy in combination with tamoxifen and goserelin (median PFS 22.1 vs 11.0 months). Additionally, Kisqali plus aromatase inhibitor and goserelin demonstrated additional 14 month PFS compared to aromatase inhibitor plus goserelin and placebo (median PFS 27.5 vs 13.8 months)[1]

 

·         Women taking Kisqali experienced a sustained and clinically meaningful improvement in pain as early as eight weeks[1]

 

·         Women taking Kisqali maintained their health-related Quality of Life for a longer time compared to those taking endocrine therapy alone[1]

 

Camberley, UK, December 6, 2017 – Novartis today announced results from the Phase III MONALEESA-7 trial in premenopausal or perimenopausal women with the most common form of advanced breast cancer, also known as hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer. Kisqali® (ribociclib) in combination with an aromatase inhibitor or tamoxifen plus goserelin as initial endocrine-based therapy demonstrated significantly prolonged progression-free survival (PFS) compared to endocrine therapy plus goserelin and placebo[1]. These data will be presented today as a late-breaker oral presentation at the 2017 San Antonio Breast Cancer Symposium (SABCS) (Abstract #GS2-05).

Kisqali in combination with tamoxifen or an aromatase inhibitor plus goserelin demonstrated a median PFS of 23.8 months (95% CI: 19.2 months-not reached) compared to 13.0 months (95% CI: 11.0-16.4 months) for tamoxifen or an aromatase inhibitor plus goserelin and placebo (HR=0.553; 95% CI: 0.441-0.694; p<0.0001)[1]. Premenopausal women treated with Kisqali combination therapy saw a response as early as eight weeks as demonstrated by separation of the PFS curves compared to endocrine therapy plus goserelin and placebo[1].

“The results from MONALEESA-7 are impressive and pending approval for use in premenopausal or perimenopausal women in the UK, ribociclib will provide a valuable treatment option whilst allowing greater flexibility in the choice of partner endocrine therapy,” 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. “Premenopausal breast cancer can be a more aggressive disease than postmenopausal breast cancer, and whilst also facing a poorer prognosis, these women have unique needs and experiences. Effective and tolerable treatment options are imperative to the future management of this challenging stage of disease.”

In the UK, around 55,000 women are diagnosed with breast cancer each year[2]. Thirty per cent of women with earlier stages of breast cancer will develop advanced disease[3], which is responsible for 90% of all breast cancer-related deaths[4]. Eighty-five per cent of women diagnosed with advanced breast cancer will not live longer than five years[5]. Premenopausal breast cancer is a biologically distinct and more aggressive disease than postmenopausal breast cancer, and it is the leading cause of cancer death in women 20-59 years old[6],[7].

MONALEESA-7 is the only Phase III study to evaluate a CDK4/6 inhibitor in combination with tamoxifen and establishes the safety and efficacy of Kisqali in this combination as first-line treatment for advanced breast cancer (median PFS of 22.1 vs 11.0 months; HR=0.585; 95% CI: 0.387-0.884)[1]. Kisqali in combination with an aromatase inhibitor demonstrated an additional 14 months progression-free survival over endocrine therapy plus goserelin and placebo (median PFS of 27.5 vs 13.8 months; HR=0.569; 95% CI: 0.436-0.743)[1].

Premenopausal women taking Kisqali benefitted for a longer time until health-related quality of life (QoL) deterioration compared to those taking endocrine therapy plus goserelin and placebo[1]. Women taking Kisqali also had a clinically meaningful improvement in pain symptoms as early as eight weeks; this improvement was sustained[1]. 

“We are delighted that the benefits of Kisqali continue to be demonstrated for women with advanced breast cancer,” said Barak Palatchi, General Manager of Novartis Oncology UK & Ireland. “The results seen in MONALEESA-7 are an essential ongoing development following our recent positive NICE recommendation for the treatment of postmenopausal patients with Kisqali, within 90 days of licence. We will work with all relevant stakeholders to make sure this additional treatment option is available for patients.”

No new safety signals were observed in the MONALEESA-7 trial; adverse events were generally consistent with those observed in MONALEESA-2, identified early and generally managed through dose interruptions or reductions[1]. Combination treatment with Kisqali was well tolerated with a discontinuation rate due to adverse events of 3.6% compared to 3.0% in patients who received endocrine therapy plus goserelin and placebo[1]. The most common (≥5%) grade 3/4 adverse events in patients receiving Kisqali combination therapy compared to endocrine therapy plus goserelin and placebo were neutropenia (60.6% vs 3.6%) and leucopenia (14.3% vs 1.2%)[1].

About MONALEESA-7

MONALEESA-7 is a Phase III randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of Kisqali in combination with tamoxifen or a non-steroidal aromatase inhibitor plus goserelin versus tamoxifen or an aromatase inhibitor plus goserelin and placebo, in premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer who had not previously received endocrine therapy for advanced disease. More than 670 women ranging from 23-58 years in age were randomized in the MONALEESA-7 trial. The first patient assessment occurred at eight weeks; separation of the PFS curves at this time was not a pre-specified endpoint of the study[1].

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[8].

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[9].

The most common adverse events of Kisqali plus letrozole were neutropenia, leucopenia, headache, back pain, nausea, fatigue, diarrhoea, vomiting, constipation, alopecia and rash, this safety data is based on the Phase III MonaLEEsa-2 clinical study[9].

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 programme, which includes MONALEESA-3 (NCT02422615). 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. This trial is 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 30 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 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.

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Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 07/12/2017

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