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Novartis Highlights New Data on Kisqali, Iptacopan, and Scemblix at SABCS and ASH

• Final analysis of the NATALEE trial showed Kisqali (ribociclib) significantly improved invasive disease-free survival in HR+/HER2- early breast cancer patients. • APPLY-PNH trial data demonstrated iptacopan monotherapy's sustained efficacy and safety in anti-C5-treated PNH patients with persistent anemia over 48 weeks. • Scemblix (asciminib) showed sustained efficacy and safety after nearly 4 years in CML-CP patients who failed ≥2 prior tyrosine kinase inhibitors.

Novartis presented data from over 100 trials across its breast cancer and hematology portfolios at the 2023 San Antonio Breast Cancer Symposium (SABCS) and the American Society of Hematology (ASH) Annual Meeting & Exposition, showcasing advances in therapies and pipeline development.

Kisqali (ribociclib) in Early Breast Cancer

Final results from the Phase III NATALEE trial investigating Kisqali (ribociclib) plus nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2- early breast cancer, including those with node-negative disease, were presented. The data demonstrated a significant improvement in invasive disease-free survival (iDFS) in a broad population of patients. These findings add to the growing body of evidence supporting the use of ribociclib in early breast cancer.

Iptacopan in Paroxysmal Nocturnal Hemoglobinuria (PNH)

New 48-week efficacy and safety data from the Phase III APPLY-PNH trial of investigational oral monotherapy iptacopan in anti-C5-treated adult patients with paroxysmal nocturnal hemoglobinuria (PNH) and persistent anemia were presented. The results showed sustained efficacy and a favorable safety profile, suggesting iptacopan could be a valuable treatment option for PNH patients.

Scemblix (asciminib) in Chronic Myeloid Leukemia (CML)

Nearly 4-year follow-up efficacy and safety results from the end-of-study treatment update of ASCEMBL with Scemblix (asciminib) in patients with Ph+ chronic phase-chronic myeloid leukemia (CP-CML) after ≥2 prior tyrosine kinase inhibitors (TKIs) were reported. The data demonstrated sustained efficacy and a manageable safety profile, reinforcing Scemblix as a viable option for CML patients who have failed multiple prior TKI therapies.
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Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH
finance.yahoo.com · Nov 20, 2023

Novartis to present over 100 trial data at SABCS and ASH 2023, including NATALEE trial's final iDFS analysis for Kisqali...

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