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

-- 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

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:

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

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

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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May 15, 2024 10:00 ET (14:00 GMT)