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Novartis highlights new 96-week results from Phase III Scemblix® ASC4FIRST trial at ASH and late-breaking analysis from Phase III Kisqali® NATALEE trial at SABCS

  • Longer-term 96-week results from Scemblix® ASC4FIRST Phase III study in first-line Ph+ CML-CP to be presented following recent FDA approval based on 48-week data
  • Late-breaking Kisqali®* 4-year analysis on distant disease-free survival in key subgroups with HR+/HER2- early breast cancer from Phase III NATALEE trial also to be presented
  • Pipeline updates demonstrate advancement in research and development programs in hematologic diseases and cancers  

Basel, November 25, 2024 – Novartis will present data from more than 65 abstracts, including investigator-initiated trials at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition and the 2024 San Antonio Breast Cancer Symposium® (SABCS).

“By prioritizing research in areas of greatest medical need and focusing on earlier stages of disease, we aim to change the treatment paradigm for people who require additional treatment options,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis. “The new data being presented at ASH and SABCS underscore our commitment to patients with cancer or blood disorders and follow new, expanded indications for Scemblix and Kisqali along with recent updates in national treatment guidelines.”

In addition to late-breaking data, Novartis will host an art gallery-style exhibit at SABCS featuring personal letters and stories written by people impacted by breast cancer, sharing their raw, authentic perspectives on aspects of the breast cancer journey. These letters and stories aim to uplift patients, encourage reflection, and demonstrate strength and unity among the breast cancer community.

Key abstracts accepted by ASH include: 

Medicine or Disease State      Abstract Title      Abstract Number/ Presentation Details       
Scemblix®Asciminib (ASC) Demonstrates Favorable Safety and Tolerability Compared with Each Investigator-Selected Tyrosine Kinase Inhibitor (IS TKI) in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) in the Pivotal Phase 3 ASC4FIRST Study

 

 

Abstract #475
Oral Presentation
Sunday, December 8
9:30 – 11:00 AM PT
Scemblix   Efficacy and Safety of Asciminib in Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Interim Results from the Phase 2 ASC2ESCALATE Trial in the Cohort of Patients (Pts) after 1 Prior Tyrosine Kinase Inhibitor (TKI)

 

 

Abstract #479
Oral Presentation
Sunday, December 8
9:30 – 11:00 AM PT
ScemblixAsciminib Shows High Efficacy and Favorable Tolerability at 80 Mg Once Daily and 40 Mg Twice Daily in Patients with Chronic Phase Chronic Myelogenous Leukemia Previously Treated with 2 or More Tyrosine Kinase Inhibitors: Primary Analysis from the ASC4OPT Study

 

Abstract #4526
Poster Presentation
Monday, December 9
6:00 – 8:00 PM PT
ScemblixTreatment with Asciminib as a Second Line after One Prior Tyrosine Kinase Inhibitor (TKI) in Patients with Chronic-Phase Chronic Myeloid Leukemia (CML-CP)– a Chart Review Study in the United States

 

Abstract #3812
Poster Presentation
Sunday, December 8
6:00 – 8:00 PM PT
Ianalumab (VAY736)A Phase 2 Study of Ianalumab in Patients with Primary Immune Thrombocytopenia Previously Treated with at Least Two Lines of Therapy: Interim Results from VAYHIT3

 

 

Abstract #710
Oral Presentation
Monday, December 9
10:30 AM – 12:00 PM PT
Rapcabtagene autoleucel (YTB323)Rapcabtagene Autoleucel (YTB323) in Patients (Pts) with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL): Phase II Trial Clinical Update

 

 

Abstract #67
Oral Presentation
Saturday, December 7
9:30 – 11:00 AM PT
Fabhalta®Oral Iptacopan Monotherapy Leads to Long-Term Improvements in Patient (Pt)-Reported Health-Related Quality of Life (HRQoL) and Investigator-Assessed Signs and Symptoms of Paroxysmal Nocturnal Hemoglobinuria (PNH): 48-Week (Wk) Results from the Phase III APPLY-PNH and APPOINT-PNH Trials

 

Abstract #4079
Poster Presentation
Monday, December 9
6:00 – 8:00 PM PT
FabhaltaThe Effect of Oral Iptacopan Monotherapy on Hematological Parameters in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Is Consistent Regardless of the Type of Prior Anti-C5 Treatment Received: A Post Hoc Analysis of 24-Week Data from the Randomized Phase III APPLY-PNH Trial

 

Abstract #4087
Poster Presentation
Monday, December 9
6:00 – 8:00 PM PT
FabhaltaBaseline Characteristics of Individuals with Paroxysmal Nocturnal Hemoglobinuria in an App-Based Home-Reported Outcomes Study to Evaluate Disease Burden

 

Abstract #2327
Poster Presentation
Saturday, December 7
5:30 – 7:30 PM PT
Pelabresib (CPI-0610)Updated Results from the Phase 3 Manifest-2 Study of Pelabresib in Combination with Ruxolitinib for Janus Kinase Inhibitor–Naïve Patients with MyelofibrosisAbstract #3178
Poster Presentation
Sunday, December 8
6:00 PM – 8:00 PM PT

Key abstracts accepted by SABCS include: 

Medicine or Disease State      Abstract Title      Abstract Number/ Presentation Details       
Kisqali® (ribociclib)*    Distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2- early breast cancer (EBC)

 

 

Abstract #P4-09-22
Poster Session
Thursday, December 12
5:30 – 7:30 PM CST

 

Kisqali     Impact of ribociclib dose reduction on efficacy in patients with hormone receptor– positive/human epidermal growth factor receptor 2–negative (HR+/HER2-) early breast cancer (EBC) in NATALEE

 

 

Abstract #P1-11-16
Poster Session
Wednesday, December 11
12:30 – 2:00 PM CST
KisqaliRisk of recurrence in real-world (RW) NATALEE- and monarchE-eligible populations of patients with HR+/HER2- early breast cancer (EBC) in an electronic health record (EHR)-derived database

 

Abstract #P2-12-02
Poster Session
Wednesday, December 11
5:30 – 7:00 PM CST

 

KisqaliTolerability of First-Line (1L) Treatment (tx) With Ribociclib (RIB) for Metastatic Breast Cancer (MBC) Using 2 Large US Data Sources

 

Abstract #P3-10-14
Poster Session
Thursday, December 12
12:30 – 2:00 PM CST

 

KisqaliImpact of body mass index (BMI) on the safety and efficacy of ribociclib (RIB) in patients (pts) with HR+/HER2- advanced breast cancer (ABC): pooled analysis of the MONALEESA (ML)-2, -3, and -7 trials

 

Abstract #P2-09-20
Poster Session
Wednesday, December 11
5:30 – 7:00 PM CST

 

KisqaliFirst-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive HR+/HER2- advanced breast cancer (ABC): a subgroup analysis of RIGHT Choice by intrinsic subtype & gene & signature expression

 

Abstract #PS2-06
Poster Presentation
Thursday, December 12
7:00 – 8:30 AM CST

 

Product Information     
For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.

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About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

# # #

* Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

Novartis Media Relations
E-mail: media.relations@novartis.com

 

  
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