Novartis Announces Updated Overall Survival Data for Kisqali With Fulvestrant

The drug combination achieved a median overall survival of more than 5 1/2 years in the first-line setting for postmenopausal women with HR+/HER2- aBC1, the company says.

Novartis announced updated median overall survival (OS) for ribociclib (Kisqali) in combination with fulvestrant in the first-line subgroup of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced or metastatic breast cancer.

The analysis of individuals treated in the first-line setting with ribociclib plus fulvestrant showed a significant OS benefit for nearly 16 months compared with those treated with fulvestrant alone. The updated exploratory OS analysis from the phase 3 MONALEESA-3 study is being presented as a late-breaker mini-oral presentation at the 2022 European Society of Medical Oncology (ESMO) Breast Cancer Congress.

“MONALEESA-3 results continue to demonstrate the survival benefit of treatment with ribociclib for postmenopausal women with advanced breast cancer,” Dennis Slamon, MD, director of Clinical/Translational Research at the Jonsson Comprehensive Cancer Center at University of California in Los Angeles, said in a statement.

“Whether partnered with fulvestrant or an aromatase inhibitor in the first-line setting, ribociclib offers oncologists a CDK4/6 inhibitor with consistent benefit in providing women with HR+/HER2- advanced breast cancer more quality time, regardless of their disease characteristics,” Slamon said.

In the MONALEESA-3 exploratory analysis, individuals were further evaluated for a median of 71 months, more than 2 1/2 years of additional follow-up since the final key secondary endpoint OS analysis. The key secondary endpoint OS analysis was presented at the ESMO Congress 2019 and published in the New England Journal of Medicine.

The final OS analysis showed a statistically significant OS benefit for the combination and a relative reduction in the risk of death by 28% compared with fulvestrant alone in the full population.

The new updated analysis with a median follow-up of 5 years showed that in the first-line setting, ribociclib with fulvestrant achieved 67.6 months median OS compared with 51.8 months with fulvestrant alone.

Additionally, those treated with the combination experienced more than 1 1/2 years of additional delay to subsequent use of chemotherapy at 49.2 months compared with fulvestrant alone at 29 months.

With this extended follow-up, the estimated survival rate at 5 years was approximately 56.5% for women who received the combination in the first line compared with 42.1% for women who received fulvestrant alone.

Additionally, approximately 16.5% of individuals in the ribociclib with fulvestrant arm were still ongoing on therapy at this longer follow-up compared with 8.6% of those in the fulvestrant arm.

There were no new adverse events observed.

“The unique profile of Kisqali continues to be reinforced, with results from MONALEESA-3 pushing the boundaries of how using a Kisqali-combination treatment regimen can extend lives of postmenopausal women living with HR+/HER2- advanced breast cancer without compromising quality of life,” Jeff Legos, executive vice president and global head of Oncology and Hematology Development at Novartis, said in the statement.

Ribociclib is the only CDK4/6 inhibitor with proven OS benefits across all 3 phase 3 advanced trails and the only CDK4/6 inhibitor with OS benefits in first-line HR-, HER+ advanced breast cancer, Novartis said in the statement.


New Novartis data demonstrate only Kisqali offers more life in the first-line setting for postmenopausal HR+/HER2- advanced breast cancer patients. Novartis. News release May 4, 2022. Accessed May 4, 2022.