Novartis' Kisqali hits main goal of late-stage breast cancer study

Novartis announced Wednesday that a Phase III study of Kisqali (ribociclib) met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, HER2-negative advanced breast cancer.

"The MONALEESA-7 trial is the first CDK 4/6 inhibitor Phase III trial designed specifically for this patient population," noted Samit Hirawat, head of global drug development at Novartis Oncology, adding that the results "may allow us to expand the population of patients who can benefit from treatment with Kisqali."

The study included more than 670 women ranging from 25 to 58 years in age and investigated the efficacy and safety of Kisqali in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in premenopausal or perimenopausal women with hormone-receptor positive, HER2-negative advanced breast cancer who had not previously received endocrine therapy for advanced disease. The company said that "no additional" safety signals were observed in the trial.

Novartis indicated that findings from the study will be presented at the San Antonio Breast Cancer Symposium (SABCS) next month. Hirawat added "we look forward to…discussing these results with regulatory agencies worldwide."

FirstWord reports in this therapy area - KOL Insight Breast Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

In March, Kisqali gained FDA approval in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone-receptor positive, HER2-negative advanced or metastatic breast cancer. The oral drug, formerly known as LEE011, gained European clearance in this indication in August and is currently authorised in 42 countries. Kisqali was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Otsuka's Astex Pharmaceuticals unit.

In 2015, Pfizer's Ibrance (palbociclib) became the first CDK4/6 inhibitor approved by the FDA for the treatment of postmenopausal women with oestrogen receptor-positive, HER2-negative metastatic breast cancer. Meanwhile, in September, the FDA authorised Eli Lilly's CDK4/6 inhibitor Verzenio (abemaciclib) to treat certain adults with hormone-receptor positive, HER2-negative breast cancer.

For related analysis, see Physician Views Poll Results: Like Kisqali, there is some room for Verzenio in an Ibrance-dominated market.

To read more Top Story articles, click here.