Novartis Highlights 96-Week Scemblix ASC4FIRST & Kisqali NATALEE Trial Results

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

Overview

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

Words from the EVEP: Novartis

• 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.

Art gallery-style exhibit by Novartis

• 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:

• 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.

• Scemblix: Asciminib 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.

• Scemblix: Treatment 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.

• Fabhalt: The 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.

• Fabhalta: Baseline 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 Myelofibrosis 
-- Abstract #3178 
-- Poster Presentation 
-- Sunday, December 8 
--6:00 PM - 8:00 PM PT.

Key abstracts accepted by SABCS include:
• 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.

• Kisqali: Risk 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

• Kisqali: Tolerability 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.

• Kisqali: Impact 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.

• Kisqali: First-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.

About the company: Novartis

• Novartis is an innovative medicines company. 
• Every day, the company 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. 
• Its medicines reach more than 250 million people worldwide.

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