Novartis Says Kisqali And Endocrine Therapy Reduces Cancer Recurrence Risk By 25%

(RTTNews) - Novartis (NVS), when presenting at the American Society of Clinical Oncology Annual Meeting, on Friday, said that its breast cancer drug Kisqali significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer in a pivotal phase III trial, dubbed NATALEE.

NATALEE is a global phase III open-label trial to evaluate the efficacy and safety of Kisqali with endocrine therapy (ET) as adjuvant treatment versus ET alone in patients s with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

In addition to meeting the primary endpoint of lowering the risk of cancer recurrence, the trial results were also consistent across all secondary endpoints, including distant disease-free survival and recurrence-free survival, with a trend for improved overall survival, the company noted.

Novartis plans to submit the phase III data to regulatory authorities in the US and Europe before the end of this year.

Commenting on the trial results, Dennis J. Slamon, NATALEE trial lead investigator, said, "These landmark results will fundamentally change how we treat patients with stage II and III HR+/HER2- early breast cancer who are in need of new, well-tolerated options that prevent their cancer from coming back."

Kisqali is already approved for the combination treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- metastatic breast cancer.

The drug generated sales of $415 million in the first quarter of 2023, an increase of 74% over the year-ago quarter.

NVS closed Thursday's trading at $97.11, up 0.89%. In premarket trading today, the stock is up 1.37% at $98.44.