Novartis (NYSE: NVS) on Tuesday said its drug Kisqali plus endocrine therapy (ET) showed a significant benefit in survival (PFS) for one year compared to combined chemotherapy (CT) in patients with advanced breast cancer in a second trial.
PFS is the length of time/after treatment the patient lives with the disease without progression.
The study, called RIGHT Choice, evaluated Kisqali (ribociclib) in combination with ET versus CT as a first-line treatment for pre- and perimenopausal patients with hormone receptor-positive, epidermal growth factor receptor-2 negative (HR+/ HER2-) metastatic breast cancer (MBC) including patients with visceral disease.
The Swiss pharmaceutical giant said Kisqali demonstrated a PFS benefit of almost one year, supporting the growth of Kisqali plus ET in this group of difficult patients.
Kisqali plus ET almost doubled the median PFS to 24 months, compared to 12.3 months with CT in the first line.
The median time to treatment failure with Kisqali plus ET was 18.6 months compared to 8.5 months with combined CT, according to the company.
In addition, patients on the Kisqali combo reported significantly lower rates of treatment-related adverse events (AEs) and less distress due to treatment-related AEs, compared to patients in the CT group.
Novartis noted that CHOICE is the first randomized trial comparing CDK4/6i plus ET versus plus CT in aggressive HR+/HER2-MBC.
“Kisqali is a unique CDK4/6 inhibitor with the strongest evidence base for overall survival and quality of life in many patients, including those with advanced disease,” said Jeff Legos, senior vice president, Global Head of Oncology and Hematology. at Novartis.