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MONALEESA-2 Trial Of Novartis' LEE011 (ribociclib) Stopped Due To Positive Efficacy Results At Interim Analysis In HR+/HER2- Advanced Breast Cancer

Shanghai Biopharmaleader Co.,Ltd | Updated: May 20, 2016

Independent Data Monitoring Committee recommends stopping the trial early as it met the primary endpoint, significantly extending progression-free survival (PFS) compared to letrozole alone, at pre-planned interim analysis[1]
LEE011 (ribociclib), a CDK4/6 inhibitor, in combination with letrozole, showed clinically meaningful improvement in PFS in postmenopausal women who had received no prior therapy for advanced breast cancer[1]
Full results will be presented at an upcoming medical congress; Novartis will initiate discussions with regulatory authorities worldwide
BASEL, Switzerland I May 18, 2016 I Novartis announced today that the MONALEESA-2 independent Data Monitoring Committee recommended stopping the trial early as results of a pre-planned interim analysis showed the trial met the primary endpoint of clinically meaningful improvement in PFS[1]. MONALEESA-2 is a pivotal Phase III trial of LEE011(ribociclib), a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole, compared to letrozole alone in postmenopausal women who had received no prior therapy for their hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer[1].

'We are excited that these results validate our belief that LEE011 in combination with letrozole can be a beneficial treatment option for women diagnosed with HR+/HER2- advanced breast cancer,' said Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology. 'Novartis is dedicated to continuing to discover and develop innovative targeted therapies that help improve and extend the lives of women living with this disease.'

As part of the company's ongoing commitment to addressing the needs of patients living with advanced breast cancer, Novartis will be evaluating possible expanded access programs in some regions to help ensure women who may benefit from LEE011 have access to it.

The adverse events observed with LEE011 in combination with letrozole in MONALEESA-2 were generally consistent with their respective known adverse event profiles[1].

The MONALEESA-2 trial will continue to assess overall survival data. Detailed efficacy and safety data will be submitted for presentation at a major medical congress and Novartis will begin discussions with global health authorities about regulatory filings.  About MONALEESA-2

MONALEESA-2 (Mammary ONcology Assessment of LEE011's Efficacy and SAfety-2) is a Phase III randomized, double blind, placebo controlled, multicenter global registration trial to evaluate the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer[1].

The trial was conducted at 294 clinical trial sites globally and randomized 668 patients in a 1:1 ratio stratified by the presence of liver and/or lung metastases[1]. Patients received LEE011 600 mg/daily (three weeks on and one week off), or placebo, in combination with letrozole 2.5 mg/daily per the approved label[1].

The primary endpoint of the trial was PFS[1]. Secondary endpoints included: overall survival, overall response rate, clinical benefit rate, health-related quality of life, safety and tolerability[1].

 

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