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Novartis’ new drug increases survival chances of patients with aggressive breast cancer

The pharma major claims that Kisqali is the only CDK4/6 inhibitor with proven overall survival benefit across all its three pivotal Phase III advanced breast cancer trials.

Novartis’ new drug increases survival chances of patients with aggressive breast cancer
The health regulator's decision is in line with an advisory panel's recommendation to not approve the drug. (File)

Novartis on Friday announced that its Kisqali adds one more year of survival benefit for patients with aggressive HR+/HER2- advanced breast cancer. According to the pharma major’s press statement, the results from a new pooled exploratory analysis across the entire MONALEESA Phase III program have revealed this significant outcome.

“This subgroup analysis found that patients with visceral metastases—including liver metastases and multiple metastatic sites, which are typically associated with a poor prognosis—who were treated with Kisqali (ribociclib) plus endocrine therapy in the first-line setting, achieved a median OS of 62.7 months compared to 52.1 months for those treated with endocrine therapy alone (HR=0.79; 95% CI: 0.65-0.97)1. Data from this analysis will be presented at the European Society of Medical Oncology (ESMO) Congress in Paris, France,” the company stated on Friday.

The pharma major claims that Kisqali is the only CDK4/6 inhibitor with proven overall survival benefit across all its three pivotal Phase III advanced breast cancer trials.

“Patients who have visceral metastases typically have a worse prognosis and often demonstrate resistance to treatment, so as a clinician it is encouraging to see significant survival benefit with ribociclib in the first-line setting in patients with more aggressive disease. Ribociclib is the only CDK4/6 inhibitor to show a consistent overall survival benefit in combination with endocrine therapy, while also maintaining quality of life across the Phase III programme,” Denise A. Yardley, MD, Senior Investigator, Breast Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, USA said in a statement.

According to the company, those with liver metastases on Kisqali plus endocrine therapy in the first-line achieved 44.2 months median OS compared to 38.1 months for those on endocrine therapy alone (HR=0.77; 95% CI: 0.55-1.07).

For patients with visceral metastases in three or more organs, first-line treatment with Kisqali-endocrine therapy achieved 57.7 months median OS compared to 49.3 months for those on endocrine therapy alone (HR=0.81; 95% CI: 0.63-1.03)1, it stated.

“The goal for advanced breast cancer treatment is to help people live longer, and we are proud that Kisqali continues to deliver a significant survival benefit while also maintaining quality of life, even for those with harder-to-treat disease. We are committed to demonstrating what makes Kisqali a unique CDK4/6 inhibitor, thus providing patients and oncologists confidence in this therapeutic option,” said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology at Novartis stated on Friday.

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