Novartis’ Kisqali the only CDK4/6 inhibitor consistent significant overall survival across entire Phase III program

Novartis’ Kisqali the only CDK4/6 inhibitor consistent significant overall survival across entire Phase III program

June 3, 2022 Off By Dino Mustafić

Novartis today announced new overall survival (OS) and quality of life (QoL) analyses which evaluated Kisqali® (ribociclib) plus endocrine therapy for patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting,  Novartis said.

In a new exploratory analysis of data from the Phase III MONALEESA-2 study, Kisqali plus letrozole maintained an OS benefit for postmenopausal patients with HR+/HER2- metastatic breast cancer treated in the first-line, including for those patients who required dose modification of Kisqali (Abstract #1017), Novartis said in a press release. Median OS seen in this analysis was 66.0 months in patients with at least one Kisqali dose reduction from the 600mg starting dose compared to 60.6 months in patients who did not have a dose reduction (95% CI: 57.6-75.7 and 42.5-79.2, respectively),  Novartis said. Additionally, it said that an OS benefit was observed in all patient subgroups treated with Kisqali and letrozole.

“Kisqali is the only CDK4/6 inhibitor to have consistently demonstrated statistically significant overall survival across its entire Phase III program,” said Reshema Kemps-Polanco, Executive Vice President, US Oncology at Novartis. “Overall survival is the ultimate goal of oncology clinical trials and what patients hope for—to live longer, and to thrive. We are extremely proud of our quality of life data and that Kisqali has the longest median overall survival ever reported in HR+/HER2- metastatic breast cancer.”

Novartis said that 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 treatment with Kisqali plus aromatase inhibitor is associated with better symptom-related QoL when indirectly compared to Verzenio®* plus an aromatase inhibitor in the first-line setting for postmenopausal patients with HR+/HER2- metastatic breast cancer (Abstract #1015). Results from the MAIC favored the Kisqali-aromatase inhibitor combination in time to sustained deterioration (TTSD), including appetite loss (HR=0.46; 95% CI: 0.27-0.81), diarrhea (HR=0.23; 95% CI: 0.23-0.79), fatigue (HR=0.63; 95% CI: 0.41-0.96) and arm symptoms (HR=0.49; 95% CI: 0.30-0.79), the company said.

“As a clinician and clinical researcher who treats patients with metastatic breast cancer, I always strive to find a therapy that gives patients more time while also maintaining the quality of that time,” said Dr. Hope S. Rugo, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education, University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. “Our indirect comparison of ribociclib plus aromatase inhibitor gives initial insight into variations in symptoms that may impact quality of life and may vary between different treatment options.”