Novartis announced Saturday that in the Phase III MONALEESA-7 trial, Kisqali (ribociclib) in combination with endocrine therapy significantly improved overall survival (OS) versus endocrine therapy alone as initial treatment in pre- and perimenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer. The results were presented at the American Society of Clinical Oncology (ASCO) annual meeting.
The company announced in 2017 that the study met its primary endpoint of progression-free survival (PFS), with results later showing that the CDK 4/6 inhibitor was associated with median PFS of 23.8 months, versus 13 months for those on tamoxifen or an aromatase inhibitor plus goserelin. Susanne Schaffert, CEO of Novartis Oncology, said "Kisqali is the only CDK4/6 inhibitor to achieve statistically significant overall survival benefit in combination with endocrine therapy."
The data disclosed at ASCO showed that median OS has not yet been reached in patients treated with Kisqali, while it was 40.9 months for those given endocrine therapy alone. Novartis noted that OS rates in the intent-to-treat population at 42 months were 70.2 percent for Kisqali combination therapy compared to 46 percent for endocrine therapy alone.
Further results from subgroup analyses showed that Kisqali plus an aromatase inhibitor demonstrated a 30-percent reduced risk of death compared to an aromatase inhibitor alone, while Kisqali plus tamoxifen was associated with a 20.9-percent reduced risk of death compared to tamoxifen alone.
Kisqali gained expanded FDA approval last year to include use in combination with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The agency also authorised Kisqali in combination with AstraZeneca's Faslodex (fulvestrant) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. The drug generated sales of $235 million in 2018, with analysts estimating that the product will bring in annual revenue of about $1.2 billion by 2024.
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