Novartis presents 96-week Scemblix ASC4FIRST and 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.

  • 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  

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

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

Fabhalta

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:

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

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