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

On November 20, 2023 Novartis reported that it 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) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Novartis, NOV 20, 2023, https://www.novartis.com/news/media-releases/novartis-showcases-significant-data-updates-from-kisqali-iptacopan-and-scemblix-sabcs-and-ash [SID1234637853]). 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.

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"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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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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