Novartis breast cancer drug cuts recurrence risk by 25 per cent in early-stage patients

The Swiss drugmaker has announced the findings at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting following its pivotal Phase III NATALEE trial.

Data showed that Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2 per cent. The results were broadly consistent regardless of patients’ menopausal status or cancer progression status.

According to the National Cancer Institute, the findings could be good news specifically for women who are diagnosed in the earlier stages of the disease and those who are hormone-receptor positive, and HER2 negative, who make up 70 per cent of the breast cancer population.

“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,” said Dr Dennis J. Slamon, director of clinical/translational research at the UCLA Jonsson Comprehensive Cancer Center and executive director of translational research in oncology.

“Addressing this unmet need across such a broad patient population could help streamline treatment decisions for healthcare providers and keep many more at-risk patients cancer-free without disrupting their daily lives.”

Dr Shreeram Aradhye, president, global drug development and chief medical officer at Novartis, said: “Patients diagnosed with HR+/HER2- early breast cancer remain at risk of cancer recurrence, given that one-third of patients diagnosed with stage II and more than half of those diagnosed with stage III will unfortunately experience a return of their cancer.

“The compelling data from NATALEE highlight the potential of Kisqali to reduce the risk of cancer recurrence in this at-risk population, including node-negative patients, while maintaining a favorable safety profile.

“These potentially practice-changing results reinforce the unique and well-established profile of Kisqali as a proven treatment in HR+/HER2- metastatic breast cancer.”

Fran Visco, National Breast Cancer Coalition president and member of the NATALEE steering committee, said: “After an early breast cancer diagnosis, patients live with a persistent and lifelong worry that their cancer will return.

“The National Breast Cancer Coalition partners with industry and scientists to help find treatments that will make certain that does not happen.”

She added: “Educated patient advocate participation in all phases of research, especially in designing and implementing clinical trials, is critical to making certain patients have meaningful options, and we are grateful that Novartis welcomed our collaboration and participation in all aspects of the NATALEE trial.”

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