Novartis has reported positive results from the Phase III MONALEESA-7 trial of KisqaliCDK4/6 inhibitor in combination tamoxifen and an aromatase inhibitor in premenopausal or perimenopausal women with hormone-receptor positive.

The enrolled patients were also suffering from human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer and had not previously received endocrine therapy for advanced disease.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The Phase III randomised, double-blind, placebo-controlled MONALEESA-7 trial evaluated 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 goserelinon the selected patients.

According to Novartis, the trial has established the safety and efficacy of the Kisqali combination therapy as first-line treatment for advanced breast cancer.

The Kisqali combination has also demonstrated an additional 14 months progression-free survival over endocrine therapy alone.

“We designed the robust MONALEESA clinical trial programme to be inclusive of all women and men with HR+/HER2- advanced breast cancer.”

Perimenopausal women taking Kisqali experienced a clinically meaningful improvement in pain, as early as eight weeks of the trialand were able to sustain and maintain their health-related quality of life (QoL) for a longer period compared to those taking only endocrine therapy.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Novartis Oncology Global Drug Development head Samit Hirawat said: “Research in premenopausal advanced breast cancer is extremely limited as these women traditionally have been excluded from clinical trials or reduced to a subgroup in trials designed for their postmenopausal counterparts.

“We designed the robust MONALEESA clinical trial programme to be inclusive of all women and men with HR+/HER2- advanced breast cancer.”

The MONALEESA-7 trial includes more than 670 women aged 23 to 58 years.

The trial carried out evaluation of its first patient at eight weeks since the beginning of the study.