Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial

Novartis International AG / Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Kisqali is the only CDK4/6 inhibitor to show superior overall survival in advanced breast cancer (HR=0.712; p=0.00973)[1]

• After a median of 42 months follow-up, the survival rate was 70.2% for women who received Kisqali combination therapy compared to 46.0% for women who received endocrine therapy alone[1]

• Advanced breast cancer in premenopausal women is the leading cause of cancer death in women 20-59 years old[2],[3]

• MONALEESA-7 overall survival results will be presented as a late-breaker at the 2019 ASCO Annual Meeting and will be published in The New England Journal of Medicine

The digital press release with multimedia content can be accessed here: 

Basel, June 1, 2019 - Novartis today announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer[1]. MONALEESA-7 overall survival results will be featured in a press briefing today, presented as a late-breaker at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract# LBA1008), and will be published in The New England Journal of Medicine.
  
The significant extension in survival met the early efficacy stopping criteria at a pre-specified interim analysis following 192 deaths (median OS, not reached vs. 40.9 [95% CI: 37.8-NE] months; HR=0.712 [0.535-0.948]; p=0.00973). Overall survival rates in the intent-to-treat population (n=672) at 42 months were 70.2% for Kisqali combination therapy compared to 46.0% for endocrine therapy alone. At the time of data cut-off, 35% of women taking Kisqali combination therapy were continuing the treatment. No new safety signals were observed[1]. Kisqali is not indicated for use with tamoxifen.