Novartis report longest median OS in breast cancer study

Novartis has announced updated median overall survival (OS) results for Kisqali (ribociclib), in combination with fulvestrant, in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer.

The results were taken from exploratory analysis of OS after an additional 16.9 months of follow-up of the Phase III MONALEESA-3 trial, and showed Kisqali combination with fulvestrant continued to demonstrate a clinically relevant OS benefit of more than a year compared with fulvestrant alone.

After a median follow-up of 56.3 months, the average OS for patients taking Kisqali in combination with fulvestrant was 53.7 months versus 41.5 months for fulvestrant alone. This follows previously reported data from trials that show a 28% reduction in the risk of death.

Dennis J. Slamon, Director of Clinical/Translational Research at the University of California, Los Angeles Jonsson Comprehensive Cancer Center, said: “Successfully demonstrating overall survival improvements in an incurable disease like metastatic breast cancer is a significant achievement, and is what we ultimately strive for in most clinical trials.

“When the MONALEESA-7 trial achieved median OS of nearly five years at SABCS 2020, it was the first time we saw a median survival this long with a CDK4/6 inhibitor in the metastatic setting. It is encouraging to see median OS results of nearly four and a half years in the MONALEESA-3 study, underscoring that ribociclib offers hope for patients to have a longer life while preserving quality of life.”

In the follow-up assessment, the need for chemotherapy was delayed to four years (48.1 months) in patients taking Kisqali in combination with fulvestrant and 28.8 months in the patients taking fulvestrant alone, and adverse events were consistent with previously reported Phase III trial results.

Susanne Schaffert, President of Novartis Oncology, said: “As overall survival data mature, we’re proud that Kisqali continues to distinguish itself, offering more life for both younger and older women living with metastatic breast cancer.

“These data confirming the sustained efficacy of Kisqali for a broad range of people with HR+/HER2- metastatic breast cancer regardless of line of therapy are unique and inspiring. Our exploration of the benefits of Kisqali continues as we evaluate its potential in the adjuvant setting.”

Kat Jenkins