In premenopausal or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer, Kisqali (ribociclib) combined with an aromatase inhibitor or tamoxifen and goserelin was shown to significantly prolong progression-free survival (PFS) compared to endocrine therapy and goserelin alone. Novartis announced the results of the Phase 3 MONALEESA-7 trial at the 2017 San Antonio Breast Cancer Symposium (SABCS). 

Kisqali, a selective cyclin-dependent kinase inhibitor, was approved in March 2017 to treat postmenopausal women with with HR+/HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor. 

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MONALEESA-7 was a double-blind study and included >670 women who were randomized to Kisqali in combination with tamoxifen or an aromatase inhibitor plus goserelin vs tamoxifen or an aromatase inhibitor plus goserelin. Results found a median PFS of 23.8 months (95% CI: 19.2 months-not reached) for the Kisqali group vs 13.0 months (95% CI: 11.0-16.4 months) for tamoxifen or an aromatase inhibitor plus goserelin (hazard ratio [HR] 0.553; 95% CI: 0.441-0.694; P<0.0001).

Women who received Kisqali combination therapy had a response as early as 8 weeks vs those who received endocrine therapy alone. 

“[This] data will give oncologists an important option if ribociclib is approved as treatment for this patient population,” said lead author Dr. Debu Tripathy, University of Texas MD Anderson Cancer Center.

The most common (≥5%) grade 3/4 adverse events in patients receiving Kisqali combination therapy compared neutropenia (60.6%) and leukopenia (14.3%), similar to the rates observed in previous studies.

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