INNOVATIVE healthcare solutions provider Novartis has announced results from the RIGHT Choice phase II trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) against combination chemotherapy (CT) in the first-line setting for pre- and perimenopausal patients with aggressive forms of hormone receptor-positive, including patients with visceral crisis.
CT has remained the preferred option for patients with rapidly progressing disease and visceral crisis with Kisqali demonstrated a nearly one-year progression-free survival (PFS) benefit in the study, thus supporting the superiority of Kisqali plus ET for this hard-to-treat patient population.
RIGHT Choice is the first randomised study comparing a CDK4/6i plus ET vs combination chemotherapy in aggressive HR+/HER2− MBC. Data from this open-label, mult-national trial was presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) recently.
“Younger patients with aggressive disease often show resistance to treatment,” Dr Yen-Shen Lu, Division Chief of Medical Oncology at Department of Oncology, National Taiwan University Hospital pointed out in a report on healthcare portal Pharmabiz.com.
“This results in worse prognosis – so it is encouraging to see RIGHT Choice data demonstrating a significant one-year benefit for this patient population when using ribociclib plus endocrine therapy compared to combination chemotherapy.”
According to Dr Yen, patients on the ribociclib arm also had lower rates of adverse events such as diarrhoea and fatigue compared to chemotherapy which could potentially impact the quality of life.
“With these improvements in outcomes and tolerability, oncologists should consider ribociclib plus ET as a treatment option for patients with aggressive forms of HR+/HER2− MBC, including patients with visceral crisis.”
The study enrolled 222 patients with aggressive forms of HR+/HER2− MBC, including more than 50% of patients with visceral crisis, as determined by investigators.
Ribociclib plus ET doubled the median PFS vs combination chemotherapy at 24 months compared to 12.3 months in the first-line setting. The median time to treatment failure with ribociclib plus ET was 18.6 months compared to 8.5 months with combination chemotherapy.
Furthermore, patients in the Ribociclib plus ET arm of the trial reported lower rates of treatment-related serious adverse events (AEs) and lower rates of discontinuation due to treatment-related AEs, compared to patients in the combination CT trial arm.
“Ribociclib is a unique CDK4/6 inhibitor with the most robust evidence demonstrating overall survival and quality of life benefits for a wide spectrum of patients, including those with aggressive disease,” said Novartis executive vice president and global head of oncology and hematology Jeff Legos.
“RIGHT Choice adds to the breadth of data that supports ribociclib as the first-line treatment of choice for patients with MBC, including those with visceral crisis.” – Dec 9, 2022