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Trial of ribociclib for advanced breast cancer meets primary endpoint
A phase 3 trial designed to evaluate the addition of ribociclib to letrozole for certain women with advanced breast cancer met its primary endpoint of PFS, according to the drug’s manufacturer.
An independent data monitoring committee recommended the trial be stopped early due to the PFS benefit demonstrated in a pre-planned interim analysis.
The randomized, double blind, multicenter MONALEESA-2 trial included 668 postmenopausal women with treatment-naive hormone receptor-positive, HER-2–negative breast cancer.
All women received letrozole. Half of the study participants received the CDK4/6 inhibitor ribociclib (LEE011, Novartis), administered in 600-mg daily doses for 3 weeks followed by 1 week off. The other half of study participants received placebo.
Researchers will continue to evaluate OS data, and full safety and efficacy results will be submitted for presentation at a future medical congress.
“We are excited that these results validate our belief that [ribociclib] in combination with letrozole can be a beneficial treatment option for women diagnosed with [hormone receptor-positive, HER-2–negative] advanced breast cancer,” Alessandro Riva, global head of oncology development and medical affairs at Novartis Oncology, said in a company-issued press release. “Novartis is dedicated to continuing to discover and develop innovative targeted therapies that help improve and extend the lives of women living with this disease.”