Novartis has unveiled Phase III data showing that partnering Kisqali with an endocrine therapy significantly prolonged progression-free survival (PFS) compared to an endocrine therapy alone in patients with breast cancer.

In the Phase III MONALEESA-7 trial, Kisqali in combination with tamoxifen or an aromatase inhibitor plus goserelin in premenopausal or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast demonstrated a median PFS of 23.8 months compared to 13.0 months for tamoxifen or an aromatase inhibitor plus goserelin.

Premenopausal women treated with Kisqali combination therapy saw a response as early as eight weeks compared to endocrine therapy alone, the drug giant noted.

“The strength of the MONALEESA-7 data is impressive and will give oncologists an important option if ribociclib is approved as treatment for this patient population as well as greater flexibility in the choice of endocrine therapy given with this agent,” said Debu Tripathy, chair of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center.

“Women who are premenopausal at the time of their breast cancer diagnosis tend to have more aggressive disease with poorer prognosis along with unique needs and experiences, so it is critical we determine which treatments will be most effective while also well tolerated.”

MONALEESA-7 trial also evaluated Kisqali in combination with tamoxifen and an aromatase inhibitor, which showed PFS of 22.1 versus 11.0 months for the latter regimen alone, while in combination with an aromatase inhibitor it demonstrated an additional 14 months progression-free survival over endocrine therapy alone (median PFS of 27.5 vs 13.8 months).

Also of note, premenopausal women taking Kisqali benefited for a longer time until health-related quality of life (QoL) deterioration compared to those taking endocrine therapy alone, and experienced a clinically meaningful improvement in pain symptoms as early as eight weeks.

Novartis plans to discuss MONALEESA-7 data with global health authorities worldwide, presumably with a view to expanding the drug’s scope of treatment.

Kisqali, a selective cyclin-dependent kinase inhibitor, is cleared by the European Commission as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. It is not currently approved for use in premenopausal patients.