Novartis has reported positive results from MONALEESA-3, a Phase III trial examining the efficacy and safety of Kisqali (ribociclib) in combination with fulvestrant compared to fulvestrant alone for the treatment of advanced or metastatic breast cancer.
The randomised, double-blind, placebo-controlled study enrolled a total of 726 postmenopausal women with HR+/HER2- advanced breast cancer who received no prior or only one line of prior endocrine therapy for advanced disease.
Out of the enrolled patients, 367 were treatment-naïve (first-line setting) and 345 had received up to one line of prior endocrine therapy for advanced disease (second-line setting).
During the trial, patients were randomised at 2:1 to receive Kisqali and fulvestrant or fulvestrant alone.
Results of the trial showed that Kisqali in combination with fulvestrant reported a median progression-free survival (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 and fulvestrant combination in the first-line setting was not reached compared to 18.3 months for fulvestrant alone.
Results have also found that the median PFS in patients receiving treatment in the second-line setting was 14.6 months compared to 9.1 months for fulvestrant alone.
MONALEESA-3 did not find any new safety signals.
Novartis Oncology Global Drug Development head Samit Hirawat said: “MONALEESA-3 data add to the robust body of evidence demonstrating the broad potential of Kisqali to treat pre and postmenopausal women living with advanced breast cancer in various endocrine combinations and multiple lines of therapy.
“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.”
Kisqali is a selective cyclin-dependent kinase inhibitor, which helps slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6.