Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care

Novartis International AG / Novartis breakthrough therapy LEE011 plus letrozole demonstrates superior progression-free survival as first-line treatment for HR+/HER2- advanced breast cancer compared to a standard of care . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• LEE011 (ribociclib) plus letrozole reduced the risk of progression or death by 44% over letrozole alone, significantly extending progression-free survival (PFS) across all patient subgroups
   

Results showed that the combination significantly improved tumor shrinkage, as more than half of women with measurable disease saw their tumor size shrink by at least 30%[1]
 

Data presented today as late-breaker during the ESMO 2016 Presidential Symposium and published simultaneously in The New England Journal of Medicine to be the basis of worldwide regulatory filings

Basel, October 8, 2016 - Results from the pivotal Phase III MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS) compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (median PFS, 95% CI (19.3 months - not reached) vs. 14.7 months (13.0 - 16.5 months); HR=0.556;  p=0.00000329)[1]. Novartis announced today that the data will be featured in the official press briefing at the European Society for Medical Oncology (ESMO) 2016 Congress and presented as a late-breaker during the Presidential Symposium at 16:30 CEST (Abstract LBA1_PR). The results will also be published simultaneously online in The New England Journal of Medicine.

The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone. The combination significantly improved PFS across all patient subgroups, regardless of disease characteristics or demographics[1]. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% (overall response rate (ORR) in patients with measurable disease = 53% vs 37%, p=0.00028)[1].