Novartis data demonstrates consistent efficacy and tolerability of Kisqali combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease

Novartis International AG / Novartis data demonstrates consistent efficacy and tolerability of Kisqali combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

•  Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine therapy alone; consistent with the overall study populations[3] 

• In patients with visceral metastasis, increased PFS benefit was seen regardless of burden of disease (=< 3 or > 3 lesions)[3]
   

Approximately 41% of postmenopausal women with HR+ advanced breast cancer will develop their first metastasis in visceral organs, such as the lungs or liver, which is often associated with a poor prognosis[1],[2]

Basel, December 8, 2018 - Novartis today announced data from subgroup analyses of the three pivotal Phase III MONALEESA trials showing that Kisqali (ribociclib) plus endocrine therapy extended progression-free survival (PFS) compared to endocrine therapy alone, regardless of the presence of visceral metastases in pre-, peri- and postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer[1]. These data will be presented today at the San Antonio Breast Cancer Symposium (SABCS) (Abstract #P6-18-07).     

"Nearly 60% of patients enrolled in the MONALEESA clinical trials had visceral metastases, and all benefited from treatment with ribociclib in combination with endocrine therapy," said Denise Yardley, MD, Principal Investigator, Sarah Cannon Research Institute. "These results, coupled with the NCCN and ABC4 recommended treatment guidelines for HR+ advanced breast cancer patients with visceral metastases, support the use of ribociclib combination therapy as a standard of care in this patient population."

In patients with visceral metastases, Kisqali plus endocrine therapy extended median PFS by 11.5 months in MONALEESA-2 (24.9 months vs 13.4 months) and 13.4 months in MONALEESA-7 (23.8 months vs 10.4 months) compared to endocrine therapy alone. Median PFS for patients with visceral metastases in the MONALEESA-3 trial still has not been reached compared to 16.5 months median PFS in patients receiving endocrine therapy alone.