Novartis’ Kisqali smashes Phase 3 primary endpoint in breast cancer for second time

pharmafile | November 8, 2017 | News story | Research and Development Cancer, Kisqali, Novartis, breast cancer, pharma 

Novartis has revealed that its immunotherapy drug Kisqali (ribociclib) met its primary endpoint of progression-free survival in its second Phase 3 trial.

The therapy was tested in combination with oral hormonal therapies and goserelin in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer, comparing its efficacy against endocrine treatment alone.

The trial is the first in 20 years to show the success of a CDK4/6 inhibitor in such a combination in this patient group.

“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,” explained Samit Hirawat, Executive Vice President and Head of Global Drug Development at Novartis Oncology. “The MONALEESA-7 trial is the first CDK 4/6 inhibitor Phase 3 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.”

Full data from the trial will be unveiled in December, presented at the 40th annual San Antonio Breast Cancer Symposium.

Matt Fellows

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