Ribociclib regimen reduces recurrence risk in subset of patients with early breast cancer
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The addition of ribociclib to adjuvant endocrine therapy significantly reduced the risk for disease recurrence among patients with hormone receptor-positive, HER2-negative early breast cancer, according to the agent’s manufacturer.
Ribociclib (Kisqali, Novartis), a category 1 preferred CDK 4/6 inhibitor, showed consistent benefit regardless of nodal involvement among patients with stage II and stage III early disease, a Novartis press release stated.
The randomized, open-label phase 3 NATALEE trial evaluated the efficacy and safety of ribociclib plus endocrine therapy vs. endocrine therapy alone as adjuvant therapy among about 5,100 patients with hormone receptor-positive, HER2-negative early breast cancer. The trial tested a lower ribociclib starting dose of 400 mg, compared with the 600 mg dose approved for treatment of metastatic breast cancer.
Researchers noted the study met its primary endpoint of invasive DFS, which incorporates locoregional relapse, ipsilateral and contralateral invasive breast cancer, distant recurrence and types of new cancer events or death due to any cause. An independent data monitoring committee has recommended the trial be stopped early after achieving this endpoint.
“While most patients are diagnosed and treated early with the aim to cure breast cancer, the risk [for] cancer returning, often as metastatic disease, peaks within 3 years after diagnosis, but never goes away completely,” Dennis J. Slamon, MD, director of clinical and translational research at University of California, Los Angeles Jonsson Comprehensive Cancer Center and NATALEE trial lead investigator, said in a press release. "There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life.”
Follow-up for long-term outcomes, including the secondary endpoint of OS, will continue and data will be presented at an upcoming medical meeting and submitted to regulatory agencies, according to Novartis.
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