Novartis announces results from RIGHT Choice Phase II trial of Kisqali

Novartis announced results from the RIGHT Choice Phase II trial evaluating Kisqali plus endocrine therapy against combination chemotherapy in the first-line setting for pre- and perimenopausal patients with aggressive forms of hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer, including patients with visceral crisis. Kisqali demonstrated a nearly one-year progression-free survival, or PFS, benefit in the study, "supporting the superiority of Kisqali plus ET for this hard-to-treat patient population," the company said. Data from this open-label, multi-national trial will be presented as a late-breaker oral presentation at the 2022 San Antonio Breast Cancer Symposium, or SABCS, and included in the SABCS press program. 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; Kisqali plus ET doubled the median PFS vs. combination CT at 24.0 months compared to 12.3 months in the first-line setting. Median time to treatment failure with Kisqali plus ET was 18.6 months compared to 8.5 months with combination CT. Furthermore, patients in the Kisqali plus ET arm of the trial reported lower rates of treatment-related serious adverse events and lower rates of discontinuation due to treatment-related AEs, compared to patients in the combination CT trial arm. Overall, the Kisqali safety profile was consistent with previously reported data, the company said. Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology at Novartis, added: "RIGHT Choice adds to the breadth of data that supports Kisqali as the first-line treatment of choice for patients with MBC, including those with visceral crisis."