Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH

• Late-breaking final iDFS analysis from NATALEE investigating Kisqali^® (ribociclib) in broad population of patients with stage II and III HR+/HER2- early breast cancer, including those with node-negative disease

• 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

• Nearly 4 year follow-up efficacy and safety results from end of study treatment update ofASCEMBL with Scemblix^® (asciminib) in patients with Ph+ chronic phase-chronic myeloid leukemia (CP-CML) after ≥2 Prior Tyrosine Kinase Inhibitors

Basel, November 20, 2023 — Novartis will present 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. The new data will highlight the latest advances across our breast cancer and hematology portfolios and pipeline, such as the Phase III NATALEE trial and Phase III APPLY-PNH trial.

“We’re developing new therapies across a range of cancers and blood disorders as well as evaluating the potential of our priority medicines in earlier stages of disease,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. “Among the new findings we will present at SABCS and ASH this year are additional follow-up Kisqali data from NATALEE, adding to the body of evidence of ribociclib in early breast cancer, as well as new 48-week data from the Phase III APPLY-PNH trial for iptacopan.”

Key highlights of data accepted by SABCS include:

Medicine	Abstract Title	Abstract Number/ Presentation Details
Kisqali® (ribociclib)*	Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: final invasive disease–free survival (iDFS) analysis from the NATALEE trial	Abstract #GS03-03  Oral Presentation  Friday, December 8  8:15 – 11:15 AM CT
Kisqali® (ribociclib)*	Invasive disease-free survival as a surrogate for overall survival in patients with hormone receptor−positive/human epidermal growth factor receptor 2−negative early breast cancer: a real-world analysis	Abstract #PO1-17-07 Poster Session Wednesday, December 6 12:00 – 2:00 PM CT
Kisqali® (ribociclib)*	Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2− early breast cancer: a discrete choice survey study	Abstract #PO2-01-09 Poster Session Wednesday, December 6 5:00 – 7:00 PM CT

Key highlights of data accepted by ASH include:  

Medicine or Disease State	Abstract Title	Abstract Number/ Presentation Details
Iptacopan (LNP023)	Factor B Inhibition with Oral Iptacopan Monotherapy Demonstrates Sustained Long-Term Efficacy and Safety in Anti-C5-Treated Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia: Final 48-Week Results from the Multicenter, Phase III APPLY-PNH Trial	Abstract #571  Oral Presentation  Sunday, December 10  4:30 PM PT
Iptacopan (LNP023)	Patient-Reported Improvements in Fatigue and Health-Related Quality of Life in the Phase 3 Studies APPLY-PNH and APPOINT-PNH Evaluating the Use of Iptacopan in C5 Inhibitor-Treated and Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria	Abstract #487  Oral Presentation  Sunday, December 10  9:30 AM PT
Iptacopan (LNP023)	Categorization of Hematological Responses to Oral Iptacopan Monotherapy in Anti-C5-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia in the Phase III APPLY-PNH Trial and Complement Inhibitor-Naïve Patients in the Phase III APPOINT-PNH Trial	Abstract #4084  Poster Presentation  Monday, December 11  6:00 – 8:00 PM PT
Iptacopan (LNP023)	Clinical Breakthrough Hemolysis (BTH) during Monotherapy with the Oral Factor B Inhibitor Iptacopan Is Generally Not Severe and Managed without Treatment Discontinuation: 48-Week Data from the Phase III APPLY-PNH and APPOINT-PNH Trials in Paroxysmal Nocturnal Hemoglobinuria (PNH)	Abstract #1338  Poster Presentation  Saturday, December 9  5:30 – 7:30 PM PT
Scemblix® (asciminib)	Sustained Efficacy and Safety with Asciminib (ASC) after Almost 4 Years of Median Follow-up from ASCEMBL, a Phase 3 Study of ASC vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) after ≥2 Prior Tyrosine Kinase Inhibitors (TKIs): An End of Study Treatment (EOS Tx) Update, Including Results from Switch Population	Abstract #4536  Poster Presentation  Monday, December 11  6:00 – 8:00 PM PT
Scemblix® (asciminib)	With up to 8 Years of Therapy, Asciminib (ASC) Monotherapy Demonstrated Continued Favorable Efficacy, Safety, and Tolerability in Patients (Pts) with Philadelphia Chromosome–Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) without the T315I Mutation: Final Results from the Phase 1 X2101 Study	Abstract #450  Oral Presentation    Sunday, December 10    10:45 AM PT
Sickle Cell Disease	Targeted Degradation of the Wiz Transcription Factor for Gamma Globin De-Repression	Abstract #2  Plenary Scientific Session  Sunday, December 10  2:00 – 4:00 PM PT
Kymriah® (tisagenlecleucel)	Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up	Abstract #601  Oral Presentation  Sunday, December 10  4:30 PM PT
Jakavi® (ruxolitinib)	Ruxolitinib in Patients With Chronic Graft-Versus-Host Disease: 3-Year Final Analysis of Efficacy and Safety From the Phase III REACH3 study	Abstract #654  Oral Presentation  Sunday, December 10  5:45 PM PT
Immune Thrombocytopenia (ITP)	The lack of tolerable treatment options that can induce durable responses without fear of relapse after discontinuation represents a significant unmet need for patients (pts) with immune thrombocytopenia (ITP): Results from the ITP world impact survey (I-WISh) 2.0	Abstract #1212  Poster Presentation  Saturday, December 9  5:30 – 7:30 PM PT

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* Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.   

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