*DJ Novartis highlights pioneering innovation in CML with data from Scemblix(R) Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA

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Press Release: Novartis highlights pioneering innovation in CML with data from Scemblix(R) Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA

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-- Primary results of the Scemblix(R) 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(R)* 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
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Basel, 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(R) (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:

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Medicine Abstract Title Abstract Number/
Presentation Details

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Scemblix                                                    ASC4FIRST, a pivotal phase 3 study of asciminib (ASC)        Abstract #LBA6500 
vs investigator-selected tyrosine kinase inhibitors          Oral presentation 
(IS TKIs) in newly diagnosed patients (pts) with chronic     Friday, May 31 
myeloid leukemia (CML): Primary results                      2:45 - 5:45pm CDT 
----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Kisqali(R) (ribociclib)                                     Baseline (BL) characteristics and efficacy endpoints         Abstract #512 
for patients (pts) with node-negative (N0) HR+/HER2-         Rapid oral presentation 
early breast cancer (EBC): NATALEE trial                     Friday, May 31 

2:45 - 4:15pm CDT

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Kisqali                                                     On-treatment (tx) dynamic circulating tumor DNA changes      Abstract #1012 
( ctDNA) associated with progression-free survival           Clinical Science Symposium 
(PFS) and overall survival (OS) of patients (pts)            Sunday, June 2 
with HR+/HER2- advanced breast cancer (ABC) in MONALEESA-3   4:30 - 6:00pm CDT 

(ML-3)

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Kisqali                                                     Short-term risk of recurrence in patients (pts) with         Abstract #541 

HR+/HER2- early breast cancer (EBC) treated with endocrine Poster presentation therapy (ET) in randomized clinical trials (RCTs): Sunday, June 2
A meta-analysis 9:00am - 12:00pm CDT

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Kisqali                                                     Real-world (RW) risk recurrence among patients (pts)         Abstract #e12533 
diagnosed with stage II-III HR+/HER2- early breast           Online publication 

cancer (EBC) treated with endocrine therapy (ET) in
the US

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Pluvicto(TM) (INN: lutetium ((177) Lu) vipivotide           Health-related quality of life and pain in a phase           Abstract #5003 
tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan)   3 study of [(177) Lu]Lu-PSMA-617 in taxane-naïve        Oral presentation 
patients with metastatic castration-resistant prostate       Saturday, June 1 
cancer (PSMAfore)                                            3:00 - 6:00pm CDT 
----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Pluvicto                                                    Baseline ctDNA analyses and associations with outcomes       Abstract #5008 
in taxane-naive patients with mCRPC treated with (177)       Oral presentation 
Lu-PSMA-617 versus change of ARPI in PSMAfore                Saturday, June 1 

3:00 - 6:00pm CDT

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Pluvicto                                                    Real-world clinical outcomes and economic burden of          Abstract #e17043 
early discontinuation of taxane therapy among patients       Online publication 

with metastatic castration-resistant prostate cancer

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Pluvicto                                                    Patient characteristics, treatment patterns and early        Abstract #e17048 
trends of lutetium Lu 177 vipivotide tetraxetan ((177)       Online publication 

Lu-PSMA-617) use by US urologists and oncologists

----------------------------------------------------------  -----------------------------------------------------------  --------------------------- 
Lutathera(R) (INN: lutetium ((177) Lu) oxodotreotide        Safety and time to response of [(177) Lu]Lu-DOTATATE         Abstract #4131 
/ USAN: lutetium Lu 177 dotatate)                           in patients with newly diagnosed advanced grade 2            Poster presentation 
and grade 3, well-differentiated gastroenteropancreatic      Saturday, June 1 
neuroendocrine tumors: Sub-analysis of the phase 3           1:30 - 4:30pm CDT 

randomized NETTER-2 study
---------------------------------------------------------- ----------------------------------------------------------- ---------------------------

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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.

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Key highlights of data accepted by EHA include:

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Medicine Abstract Title Abstract Number/
Presentation Details

-----------------------  --------------------------------------------------------------  -------------------------- 
Scemblix                 Asciminib (ASC) provides superior efficacy and excellent        Abstract #S103 
safety and tolerability vs tyrosine kinase inhibitors           Plenary oral presentation 

(TKI) in newly diagnosed chronic myeloid leukemia Saturday, June 15

(CML) in the pivotal ASC4FIRST study                            2:45 - 4:15pm CEST 
-----------------------  --------------------------------------------------------------  -------------------------- 
Scemblix                 Asciminib (ASC) is well tolerated in pediatric patients         Abstract #P1865 
with chronic myeloid leukemia in chronic phase (CML-CP):        e-Poster presentation 

interim pharmacokinetics and safety results from ASC4KIDS

-----------------------  --------------------------------------------------------------  -------------------------- 
Fabhalta(R) (iptacopan)  Effects of oral iptacopan monotherapy, including increased      Abstract #P829 
paroxysmal nocturnal hemoglobinuria red blood cell              Poster presentation 
clone size, are sustained in anti-c5-treated patients           Friday, June 14 
with anemia: final APPLY-PNH data                               9:00am CEST 
-----------------------  --------------------------------------------------------------  -------------------------- 
Fabhalta                 Effects of oral iptacopan monotherapy, including increased      Abstract #P822 
paroxysmal nocturnal hemoglobinuria red blood cell              Poster presentation 
clone size, are maintained in complement inhibitor-naïve   Friday, June 14 
patients: final APPOINT-PNH data                                9:00am CEST 
-----------------------  --------------------------------------------------------------  -------------------------- 
Fabhalta                 Patient experience of iptacopan in three clinical               Abstract #P1918 
trials for paroxysmal nocturnal hemoglobinuria                  e-Poster presentation 
-----------------------  --------------------------------------------------------------  -------------------------- 

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

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