May 15, 2024
  • Primary results of the Scemblix® ASC4FIRST pivotal Phase III study in first-line Ph+ CML-CP supporting third US FDA Breakthrough Therapy designation, to be detailed in the ASCO Press Program and the EHA Plenary Session
     
  • Latest data from the Kisqali®* NATALEE trial, including efficacy endpoints for patients with node-negative stage II and III HR+/HER2- early breast cancer
     
  • New radioligand therapy portfolio data supporting overall platform leadership and ongoing expansion in research infrastructure and supply capabilities

East Hanover, May 15, 2024 – Novartis will present data from more than 60 abstracts, including investigator-initiated trials at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2024 Hybrid Congress. The primary results from ASC4FIRST, a pivotal Phase III study of Scemblix® (asciminib) versus standard of care tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib, and bosutinib) in newly diagnosed patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) will be shared at the ASCO official Press Program and at the EHA Plenary Session.

“Despite progress, people with CML continue to struggle to find treatment that is both efficacious and tolerable for them at diagnosis and beyond. We look forward to sharing the primary analysis from the pivotal Phase III ASC4FIRST trial, which builds on our over 20-year legacy to transform care for people diagnosed with CML,” said Jeff Legos, Executive Vice President, Global Head of Oncology, Novartis. “With these promising data, a new analysis of the NATALEE trial in patients with node-negative early breast cancer and additional updates from our RLT portfolio, we further our efforts to reimagine medicine for those with cancer in partnership with the scientific community.”

Key highlights of data accepted by ASCO include:

Medicine     

Abstract Title     

Abstract Number/ Presentation Details      

Scemblix

ASC4FIRST, a pivotal phase 3 study of asciminib (ASC) vs investigator-selected tyrosine kinase inhibitors (IS TKIs) in newly diagnosed patients (pts) with chronic myeloid leukemia (CML): Primary results

 

Abstract #LBA6500

Oral presentation

Friday, May 31

2:45 - 5:45pm CDT

 

Kisqali® (ribociclib)

 

Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2− early breast cancer (EBC): NATALEE trial

 

Abstract #512

Rapid oral presentation

Friday, May 31

2:45 - 4:15pm CDT

Kisqali

 

On-treatment (tx) dynamic circulating tumor DNA changes (∆ctDNA) associated with progression-free survival (PFS) and overall survival (OS) of patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA-3 (ML-3)

 

Abstract #1012

Clinical Science Symposium

Sunday, June 2

4:30 - 6:00pm CDT

 

Kisqali

 

Short-term risk of recurrence in patients (pts) with HR+/HER2− early breast cancer (EBC) treated with endocrine therapy (ET) in randomized clinical trials (RCTs): A meta-analysis

 

Abstract #541

Poster presentation

Sunday, June 2

9:00am - 12:00pm CDT

Kisqali     

Real-world (RW) risk recurrence among patients (pts) diagnosed with stage II-III HR+/HER2- early breast cancer (EBC) treated with endocrine therapy (ET) in the US

  

Abstract #e12533

Online publication

Pluvicto® (lutetium Lu 177 vipivotide tetraxetan)

 

Health-related quality of life and pain in a phase 3 study of [177Lu]Lu-PSMA-617 in taxane-naïve patients with metastatic castration-resistant prostate cancer (PSMAfore)

 

Abstract #5003        

Oral presentation

Saturday, June 1

3:00 - 6:00pm CDT

 

Pluvicto

Baseline ctDNA analyses and associations with outcomes in taxane-naive patients with mCRPC treated with 177Lu-PSMA-617 versus change of ARPI in PSMAfore

 

Abstract #5008        

Oral presentation

Saturday, June 1

3:00 - 6:00pm CDT

 

Pluvicto

Real-world clinical outcomes and economic burden of early discontinuation of taxane therapy among patients with metastatic castration-resistant prostate cancer

 

Abstract #e17043

Online publication

 

Pluvicto

Patient characteristics, treatment patterns and early trends of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) use by US urologists and oncologists

 

Abstract #e17048

Online publication

Lutathera® (lutetium Lu 177 dotatate)

 

Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study

Abstract #4131

Poster presentation

Saturday, June 1

1:30 - 4:30pm CDT

 

 

At the ASCO Annual Meeting, Novartis will also address health equity at the company’s booth on the meeting floor, with the More Than Just Words virtual reality experience. Meeting attendees will have the opportunity to immerse themselves in scenarios inspired by real-life microaggressions Black patients face due to bias in care, and explore resources co-created with leading multidisciplinary experts to help foster productive, nonbiased conversations about breast cancer risk, diagnosis, and care.

Key highlights of data accepted by EHA include:   

Medicine   

Abstract Title     

Abstract Number/ Presentation Details      

Scemblix

Asciminib (ASC) provides superior efficacy and excellent safety and tolerability vs tyrosine kinase inhibitors (TKI) in newly diagnosed chronic myeloid leukemia (CML) in the pivotal ASC4FIRST study

 

Abstract #S103

Plenary oral presentation

Saturday, June 15

2:45 - 4:15pm CEST

 

Scemblix

Asciminib (ASC) is well tolerated in pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP): interim pharmacokinetics and safety results from ASC4KIDS 

 

Abstract #P1865

e-Poster presentation

Fabhalta® (iptacopan)

 

Effects of oral iptacopan monotherapy, including increased paroxysmal nocturnal hemoglobinuria red blood cell clone size, are sustained in anti-c5-treated patients with anemia: final APPLY-PNH data

Abstract #P829

Poster presentation

Friday, June 14

9:00am CEST

Fabhalta

Effects of oral iptacopan monotherapy, including increased paroxysmal nocturnal hemoglobinuria red blood cell clone size, are maintained in complement inhibitor-naïve patients: final APPOINT-PNH data

 

Abstract #P822

Poster presentation

Friday, June 14

9:00am CEST

Fabhalta

 

Patient experience of iptacopan in three clinical trials for paroxysmal nocturnal hemoglobinuria

 

Abstract #P1918

e-Poster presentation

 

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 https://www.novartis.us and connect with us on LinkedIn, LinkedIn US, Facebook, X/Twitter, X/Twitter US and Instagram.

 

* Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals. 

 

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