Kisqali meet endpoints in MONALEESA-7 trial in advanced or metastatic breast cancer.-Novartis.

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.

More than 670 women ranging from 25-58 years in age were randomized in the MONALEESA-7 trial. No additional safety signal was identified in the MONALEESA-7 study. 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.

Comment: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. The MONALEESA-7 trial is the first CDK 4/6 inhibitor Phase III trial designed specifically for this patient population.

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. 2. 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. 3. 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.4. 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. 5. 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 6. EarLEE-2 will enroll women with HR+/HER2- intermediate-risk early breast cancer.