Press Release: Novartis highlights new 96-week results from Phase III Scemblix(R) ASC4FIRST trial at ASH and late-breaking analysis from Phase III Kisqali(R)...

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-- Longer-term 96-week results from Scemblix(R) 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(R)* 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 66(th) American Society of Hematology (ASH) Annual Meeting & Exposition and the 2024 San Antonio Breast Cancer Symposium(R) (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 Abstract Title Abstract Number/

Disease Presentation Details

State

------------ ---------------------------------------------------------------- ------------------------

Scemblix(R) Asciminib (ASC) Demonstrates Favorable Safety and Abstract #475

Tolerability Compared with Each Investigator-Selected Oral Presentation

Tyrosine Kinase Inhibitor (IS TKI) in Newly Diagnosed Sunday, December 8

Chronic Myeloid Leukemia in Chronic Phase (CML-CP) 9:30 -- 11:00 AM PT

in the Pivotal Phase 3 ASC4FIRST Study

------------ ---------------------------------------------------------------- ------------------------

Scemblix Efficacy and Safety of Asciminib in Chronic Myeloid Abstract #479

Leukemia in Chronic Phase (CML-CP): Interim Results Oral Presentation

from the Phase 2 ASC2ESCALATE Trial in the Cohort Sunday, December 8

of Patients (Pts) after 1 Prior Tyrosine Kinase Inhibitor 9:30 -- 11:00 AM PT

(TKI)

------------ ---------------------------------------------------------------- ------------------------

Scemblix Asciminib Shows High Efficacy and Favorable Tolerability Abstract #4526

at 80 Mg Once Daily and 40 Mg Twice Daily in Patients Poster Presentation

with Chronic Phase Chronic Myelogenous Leukemia Previously Monday, December 9

Treated with 2 or More Tyrosine Kinase Inhibitors: 6:00 -- 8:00 PM PT

Primary Analysis from the ASC4OPT Study

------------ ---------------------------------------------------------------- ------------------------

Scemblix Treatment with Asciminib as a Second Line after One Abstract #3812

Prior Tyrosine Kinase Inhibitor (TKI) in Patients Poster Presentation

with Chronic-Phase Chronic Myeloid Leukemia (CML-CP)-- Sunday, December 8

a Chart Review Study in the United States 6:00 -- 8:00 PM PT

------------ ---------------------------------------------------------------- ------------------------

Ianalumab A Phase 2 Study of Ianalumab in Patients with Primary Abstract #710

(VAY736) Immune Thrombocytopenia Previously Treated with at Oral Presentation

Least Two Lines of Therapy: Interim Results from VAYHIT3 Monday, December 9

10:30 AM -- 12:00 PM PT

------------ ---------------------------------------------------------------- ------------------------

Rapcabtagene Rapcabtagene Autoleucel (YTB323) in Patients (Pts) Abstract #67

autoleucel with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Oral Presentation

(YTB323) (R/R DLBCL): Phase II Trial Clinical Update Saturday, December 7

9:30 -- 11:00 AM PT

------------ ---------------------------------------------------------------- ------------------------

Fabhalta(R) Oral Iptacopan Monotherapy Leads to Long-Term Improvements Abstract #4079

in Patient (Pt)-Reported Health-Related Quality of Poster Presentation

Life (HRQoL) and Investigator-Assessed Signs and Symptoms Monday, December 9

of Paroxysmal Nocturnal Hemoglobinuria (PNH): 48-Week 6:00 -- 8:00 PM PT

(Wk) Results from the Phase III APPLY-PNH and APPOINT-PNH

Trials

------------ ---------------------------------------------------------------- ------------------------

Fabhalta The Effect of Oral Iptacopan Monotherapy on Hematological Abstract #4087

Parameters in Patients with Paroxysmal Nocturnal Hemoglobinuria Poster Presentation

(PNH) Is Consistent Regardless of the Type of Prior Monday, December 9

Anti-C5 Treatment Received: A Post Hoc Analysis of 6:00 -- 8:00 PM PT

24-Week Data from the Randomized Phase III APPLY-PNH

Trial

------------ ---------------------------------------------------------------- ------------------------

Fabhalta Baseline Characteristics of Individuals with Paroxysmal Abstract #2327

Nocturnal Hemoglobinuria in an App-Based Home-Reported Poster Presentation

Outcomes Study to Evaluate Disease Burden Saturday, December 7

5:30 -- 7:30 PM PT

------------ ---------------------------------------------------------------- ------------------------

Pelabresib Updated Results from the Phase 3 Manifest-2 Study Abstract #3178

(CPI-0610) of Pelabresib in Combination with Ruxolitinib for Poster Presentation

Janus Kinase Inhibitor--Naïve Patients with Myelofibrosis Sunday, December 8

6:00 PM - 8:00 PM PT

------------ ---------------------------------------------------------------- ------------------------

Key abstracts accepted by SABCS include:

Medicine or Abstract Title Abstract Number/

Disease Presentation Details

State

------------- ---------------------------------------------------------- -----------------------

Kisqali(R) Distant disease-free survival (DDFS) across key subgroups Abstract #P4-09-22

(ribociclib)* from the phase 3 NATALEE trial of ribociclib (RIB) Poster Session

plus a nonsteroidal aromatase inhibitor (NSAI) in Thursday, December 12

patients with HR+/HER2- early breast cancer (EBC) 5:30 -- 7:30 PM CST

------------- ---------------------------------------------------------- -----------------------

Kisqali Impact of ribociclib dose reduction on efficacy in Abstract #P1-11-16

patients with hormone receptor-- positive/human epidermal Poster Session

growth factor receptor 2--negative (HR+/HER2-) early Wednesday, December 11

breast cancer (EBC) in NATALEE 12:30 -- 2:00 PM CST

------------- ---------------------------------------------------------- -----------------------

Kisqali Risk of recurrence in real-world (RW) NATALEE- and Abstract #P2-12-02

monarchE-eligible populations of patients with HR+/HER2- Poster Session

early breast cancer (EBC) in an electronic health Wednesday, December 11

record (EHR)-derived database 5:30 -- 7:00 PM CST

------------- ---------------------------------------------------------- -----------------------

Kisqali Tolerability of First-Line (1L) Treatment (tx) With Abstract #P3-10-14

Ribociclib (RIB) for Metastatic Breast Cancer (MBC) Poster Session

Using 2 Large US Data Sources Thursday, December 12

12:30 -- 2:00 PM CST

------------- ---------------------------------------------------------- -----------------------

Kisqali Impact of body mass index (BMI) on the safety and Abstract #P2-09-20

efficacy of ribociclib (RIB) in patients (pts) with Poster Session

HR+/HER2- advanced breast cancer (ABC): pooled analysis Wednesday, December 11

of the MONALEESA (ML)-2, -3, and -7 trials 5:30 -- 7:00 PM CST

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November 25, 2024 01:15 ET (06:15 GMT)