Novartis Highlights Scemblix and Kisqali Data at ASH and SABCS
Key Insights
Scemblix demonstrated favorable safety and tolerability in newly diagnosed chronic myeloid leukemia (search) patients in the ASC4FIRST Phase III study.
Kisqali showed promising distant disease-free survival across key subgroups in HR+/HER2- early breast cancer (search) from the Phase III NATALEE trial.
Novartis is presenting over 65 abstracts at ASH and SABCS, showcasing advancements in hematologic diseases and cancers.
Novartis presented data from over 65 abstracts at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition and the 2024 San Antonio Breast Cancer (search) Symposium® (SABCS), highlighting advancements in treatments for hematologic diseases and cancers.
Scemblix (asciminib) Shows Promise in Chronic Myeloid Leukemia
Longer-term 96-week results from the Scemblix® ASC4FIRST Phase III study in first-line Philadelphia chromosome-positive chronic myeloid leukemia (search) in chronic phase (Ph+ CML-CP) were presented. The study demonstrated favorable safety and tolerability compared to investigator-selected tyrosine kinase inhibitors (TKIs) in newly diagnosed patients. These findings build upon the recent FDA approval of Scemblix based on 48-week data.
Additional Scemblix data included interim results from the Phase 2 ASC2ESCALATE trial in patients after one prior TKI, and primary analysis from the ASC4OPT study in patients previously treated with two or more TKIs. A chart review study in the United States also examined Scemblix treatment as a second-line therapy after one prior TKI in CML-CP patients.
Kisqali (ribociclib) Demonstrates Efficacy in Early Breast Cancer
A late-breaking 4-year analysis from the Phase III NATALEE trial of Kisqali® plus a nonsteroidal aromatase inhibitor (NSAI) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (search) (EBC) was presented. The analysis focused on distant disease-free survival (DDFS) across key subgroups, providing further evidence of Kisqali's benefit in this patient population.
Additional Kisqali data included the impact of dose reduction on efficacy in the NATALEE trial, risk of recurrence in real-world NATALEE- and monarchE-eligible populations, tolerability of first-line treatment in metastatic breast cancer (search), impact of body mass index on safety and efficacy in advanced breast cancer, and a subgroup analysis of first-line ribociclib plus endocrine therapy versus combination chemotherapy in clinically aggressive HR+/HER2- advanced breast cancer.
Further Pipeline Updates
Beyond Scemblix and Kisqali, Novartis presented data on other investigational and approved therapies, including: Ianalumab (VAY736) in primary immune thrombocytopenia (search), Rapcabtagene autoleucel (YTB323) in relapsed/refractory diffuse large B-cell lymphoma (search), Fabhalta® (iptacopan) in paroxysmal nocturnal hemoglobinuria (search) (PNH), and Pelabresib (CPI-0610) in myelofibrosis (search). These updates demonstrate the breadth of Novartis's research and development programs in hematologic diseases and cancers.