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Novartis to seek approval of Kisqali plus fulvestrant for postmenopausal women with advanced breast cancer

Novartis on Sunday announced positive results from the third Phase III trial of Kisqali in advanced or metastatic breast cancer.

According to Novartis, the trial Monaleesa-3 showed Kisqali plus fulvestrant significantly prolonged progression-free survival (PFS) compared to fulvestrant alone in postmenopausal women with hormone-receptor positive advanced breast cancer.

Monaleesa-3 is the largest phase III trial to evaluate efficacy and safety of a CDK4/6 inhibitor plus fulvestrant in multiple advanced breast cancer patient populations – first-line and second-line settings, Novartis noted.

Notably, Kisqali in combination with fulvestrant demonstrated a median PFS of 20.5 months compared to 12.8 months for fulvestrant alone across both treatment arms. The median PFS for the subgroup of patients receiving Kisqali plus fulvestrant in the first-line setting, including only de novo patients and those whose disease relapsed >12 months since end of neo(adjuvant) endocrine therapy, was not reached compared to 18.3 months for fulvestrant alone. In patients receiving treatment in the second-line setting, or those who relapsed <12 months since end of neo(adjuvant) endocrine therapy, the median PFS was 14.6 months compared to 9.1 months for fulvestrant alone, Novartis revealed.

Dennis J. Slamon, from University of California, LA Jonsson Comprehensive Cancer Center, noted that nearly 70% of women who received (Kisqali) ribociclib plus fulvestrant in this setting were estimated to remain progression-free at the median follow-up of 16.5 months.

Fifty percent of the women in the trial had lung and/or liver metastases and showed a consistent treatment benefit compared with the overall population. Follow-up to measure overall survival is ongoing as these data remain immature.

Samit Hirawat, Head, Novartis Oncology Global Drug Development, said: “These results along with the other MONALEESA studies build a compelling case that Kisqali combination therapy should be a cornerstone of first-line treatment of HR+/HER2- advanced breast cancer.”

Novartis said it is looking to seek approval of Kisqali plus fulvestrant for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer from the FDA.

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