Novartis has had received positive topline results from its global MONALEESA-7 trial of Kisqali for metastatic breast cancer, the company announced in a press release.
The trial achieved the "primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer," according to the release.
MONALEESA-7 is the first prospective global Phase II trial in over 20 years and is specifically meant for premenopausal women diagnosed with advanced breast cancer.
"There remains a significant unmet treatment need in younger women diagnosed with premenopausal advanced breast cancer, as the disease tends to be more aggressive with a poorer prognosis," Samit Hirawat, executive vice president and head of global drug development at Novartis Oncology, said in the release. "The MONALEESA-7 trial is the first CDK 4/6 inhibitor Phase III trial designed specifically for this patient population, and we are excited that the study met its primary endpoint, which may allow us to expand the population of patients who can benefit from treatment with Kisqali."
MONALEESA-7 is a Phase III randomized and double-blind, placebo-controlled trial that looks into the efficacy and safety of Kisqali when combined with oral hormonal therapies and goserelin compared to endocrine treatment alone, according to the release.