2023-03-28| Trials & Approvals

Novartis’ CDK4/6 Inhibitor Meets Phase 3 Endpoints In Breast Cancer

by Joy Lin
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Novartis has announced positive topline results from a Phase 3 trial of Kisqali (ribociclib) in early breast cancer. 

The trial, called Natalee, was stopped early by the recommendation of the Independent Data Monitoring Committee as the primary endpoint of invasive disease-free survival has been met. Kisqali plus endocrine therapy (ET) significantly reduced the risk of breast cancer recurring, and showed consistent benefit in patients with stage II and stage III EBC regardless of nodal involvement. According to Novartis, Natalee is the first trial to show such a benefit in this EBC population. 

Natalee’s results will be presented at an upcoming medical meeting, with submissions to regulatory authorities worldwide, said Novartis. 

Related Article: Novartis Snags Pediatric Brain Cancer Indication for Oncology Combination Therapy

Novartis Eyes Kisqali in Earlier Lines of Breast Cancer Treatment

“While most patients are diagnosed and treated early with the aim to cure breast cancer, the risk of cancer returning, often as metastatic disease, peaks within three years after diagnosis, but never goes away completely,” said Dennis J. Slamon, M.D., Director of Clinical/Translational Research at the University of California Natalee’s lead investigator. 

“There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life. The Natalee trial, where ribociclib was given for three years plus ET, was designed with these unmet needs in mind, and it is extremely encouraging that this study met its primary endpoint,” he said.

Kisqali inhibits CDK4/6 to prevent cancer cells from proliferating.  Approved to treat HR+/HER2- metastatic breast cancer (MBC) in 99 countries including the US and Europe, its consistent survival benefits while preserving or improving the quality of life has merited a recommendation from the NCCN Guidelines as the only Category 1 preferred CDK4/6 inhibitor for first-line MBC when combined with an aromatase inhibitor (AI). 

Novartis is aiming to bring Kisqali to an earlier-stage setting in breast cancer treatment. Succeeding in this can expand Kisqali’s market share, racking up the competition between Pfizer’s Ibrance (palbociclib) and Eli Lilly’s Verzenio (abemaciclib). 

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