Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its 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.

MONALEESA-7 is the first prospective global Phase III trial in more than 20 years, designed specifically for premenopausal women diagnosed with advanced breast cancer, to demonstrate superiority of any CDK4/6 inhibitor in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in this patient population[1].

"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," said Samit Hirawat, Executive Vice President and Head, Global Drug Development at Novartis Oncology. "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. We look forward to presenting MONALEESA-7 study data at SABCS next month and discussing these results with regulatory agencies worldwide."

MONALEESA-7 is a Phase III randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Kisqali in combination with oral hormonal therapies and goserelin versus endocrine treatment alone in premenopausal or perimenopausal women with HR+/HER2- advanced breast cancer who had not previously received endocrine therapy for advanced disease. More than 670 women ranging from 25-58 years in age were randomized in the MONALEESA-7 trial[1].

No additional safety signal was identified in the MONALEESA-7 study[1]. Results of MONALEESA-7 trial will be presented at the 40th annual San Antonio Breast Cancer Symposium (SABCS) in December. Novartis plans to begin discussions with global health authorities worldwide.

About Kisqali® (ribociclib)

Kisqali (ribociclib) is the only CDK4/6 inhibitor approved based on a first-line, Phase III trial that met its primary endpoint early. It is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.  Kisqali is not approved for use in premenopausal patients.

Kisqali is approved for use in 42 countries around the world, including the United States, European Union. Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

About the Kisqali Clinical Trial Program

With more than 2,000 patients, the MONALEESA program is the largest Phase III clinical program researching use of a CDK4/6 inhibitor in advanced breast cancer[1].

The MONALEESA-7 findings add to the body of evidence from MONALEESA-2 supporting the benefit of Kisqali plus hormone therapy in first-line treatment of HR+/HER2- advanced or metastatic breast cancer. Novartis is continuing to evaluate Kisqali in combination with multiple hormonal therapies across a broad range of patients, including in the adjuvant setting.

MONALEESA-3 is a Phase III study evaluating Kisqali in combination with fulvestrant compared to fulvestrant alone in postmenopausal women with HR+/HER2- advanced breast cancer who have received no or a maximum of one prior endocrine therapy.

CompLEEment is an open-label, multicenter, Phase IIIb study evaluating the safety and efficacy of Kisqali plus letrozole in men and pre- or postmenopausal women with HR+/HER2- advanced breast cancer who have not received prior hormonal therapy for advanced disease.

EarLEE-1 and EarLEE-2 are multi-center, randomized, double-blind Phase III clinical trials that will evaluate the safety and efficacy of Kisqali with endocrine therapy as adjuvant therapy in pre- and postmenopausal women who have not previously received treatment with a CDK4/6 inhibitor. EarLEE-1 will assess Kisqali plus adjuvant endocrine therapy compared to adjuvant endocrine therapy alone in women with HR+/HER2- high-risk early breast cancer and EarLEE-2 will enroll women with HR+/HER2- intermediate-risk early breast cancer.