Novartis has announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy.
The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
MONALEESA-7 overall survival results were featured in a press briefing, presented as a late-breaker at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract# LBA1008), and will be published in The New England Journal of Medicine.
The significant extension in survival met the early efficacy stopping criteria at a pre-specified interim analysis following 192 deaths. Overall survival rates in the intent-to-treat population at 42 months were 70.2% for Kisqali combination therapy compared to 46.0% for endocrine therapy alone. At the time of data cut-off, 35% of women taking Kisqali combination therapy were continuing the treatment.
Results from subgroup analyses showed that Kisqali plus an aromatase inhibitor demonstrated a 30.0% reduced risk of death compared to an aromatase inhibitor alone. Kisqali plus tamoxifen demonstrated a 20.9% reduced risk of death compared to tamoxifen alone. Kisqali is not indicated for use with tamoxifen.
Dr Sara Hurvitz, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit and Director of the Breast Cancer Clinical Trials Program at UCLA, said: “Impactful results like these ribociclib findings are what we wish for in every clinical trial, and to achieve overall survival improvement in an incurable disease, like metastatic breast cancer, is truly an outstanding advancement for patients.”
Susanne Schaffert, Ph.D., CEO, Novartis Oncology, added: “Kisqali is the only CDK4/6 inhibitor to achieve statistically significant overall survival benefit in combination with endocrine therapy, and we are so proud to share these powerful data with the medical and patient community.”
MJ DeCoteau, Executive Director of Rethink Breast Cancer, said, “Breast cancer is the leading cause of cancer death in women 20-59, so knowing an approved treatment has been proven to help them live longer is an outstanding advancement and provides new hope for women with this devastating disease.”