September 21, 2020: “Novartis proudly announces that Kisqali® (ribociclib) has achieved a score of five out of five on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for first-line premenopausal patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
This perfect score was achieved as a result of the significant overall survival benefit and the quality of life improvements demonstrated by Kisqali plus endocrine therapy for premenopausal women in the Phase III MONALEESA-7 trial.
Related News: Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer
Kisqali also received an ESMO-MCBS score of four out of five, the highest score achieved by any CDK 4/6 inhibitor in combination with fulvestrant for first-line postmenopausal patients, based on the statistically significant overall survival benefit observed in the Phase III MONALEESA-3 study and maintained quality of life.
A score of four out of five was also granted for Kisqali plus fulvestrant in the second-line setting based on the MONALEEA-3 study.
Achieving a five on the ESMO-MCBS is the highest grade in the non-curative setting, and Kisqali received the highest scores across the board in advanced or metastatic breast cancer due to the body of evidence supporting the overall survival and quality of life benefits it provides.
The ESMO-MCBS is a validated tool for physicians to assess the value of cancer treatments, and ultimately make informed treatment decisions for their patients.
Additionally, new Kisqali data will be presented during the ESMO Virtual Congress 2020 further build on the robust body of evidence. Key presentations include:
- An analysis that found Kisqali plus endocrine therapy demonstrated consistent improvement in overall survival in patients with endocrine-resistant HR+/HER2- advanced breast cancer, which is typically more challenging to treat.
Treatment with Kisqali in patients with endocrine resistance led to a 30% and 41% reduction in the risk of death in the MONALEESA-3 and -7 studies over standard endocrine therapy, respectively. Safety was consistent with the overall study populations in both trials.
- An oral presentation of a robust pooled analysis of patient-reported outcomes from MONALEESA-2, -3, and -7 trials in first-line patients, which demonstrated improvement in quality of life for patients with HR+/HER2- advanced breast cancer upon receiving Kisqali plus endocrine therapy with consistency in different subgroups analyzed.
- A matching-adjusted indirect comparison (MAIC), a method used to estimate the comparative effectiveness of treatments after adjusting for differences in the patient populations where head-to-head trials do not exist, indicated that patients taking Kisqali plus fulvestrant as first-line therapy may live significantly longer than those taking palbociclib plus letrozole, based on the MONALEESA-3 and PALOMA-1 trials, respectively.
A trend toward improved progression free survival (PFS) for Kisqali plus fulvestrant versus palbociclib plus letrozole was also observed.
“The totality of these data presented at ESMO confirm the proven overall survival and quality of life benefits with Kisqali, reinforcing it as the standard of care for advanced breast cancer patients,” said Susanne Schaffert, PhD, President, Novartis Oncology.
“We are proud to continue advancing the science across multiple breast cancer patient populations, including exploring the potential of Kisqali in early breast cancer.”
Kisqali® (ribociclib)
Kisqali is the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent and sustained efficacy compared to endocrine therapy alone.
Overall survival results from MONALEESA-7 and MONALEESA-3 were presented at ASCO 2019 and ESMO 2019 respectively, demonstrating Kisqali plus endocrine therapy significantly extends life in pre/perimenopausal or postmenopausal women with HR+/HER2- advanced breast cancer.
Overall survival follow-up is ongoing for the Phase III MONALEESA-2 trial.
Kisqali was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial.
Kisqali in combination with an aromatase inhibitor was approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA in July 2018 and by the EC in December 2018.
Regulatory filings are underway with other health authorities worldwide.
Novartis is continuing to reimagine cancer by investigating Kisqali in early breast cancer.
The NATALEE study is a Phase III clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO).
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.”
https://www.novartis.com/news/media-releases/novartis-kisqali-receives-highest-rating-any-cdk46-inhibitor-esmo-magnitude-clinical-benefit-scale
