Novartis to present new data across oncology portfolio including Kisqali Phase III NATALEE trial in early breast cancer at ASCO

• Primary analysis of NATALEE, the first and only positive Phase III study of a CDK4/6 inhibitor in a broad population of patients with stage II and III HR+/HER2- early breast cancer at risk of recurrence, including those with no nodal involvement, to be presented
  
  
• New analyses from the Pluvicto VISION trial in prostate cancer and the JDQ443 KontRASt-01 trial in KRAS G12C-mutated lung cancer among 40+ Novartis abstracts accepted at ASCO, underscoring strength of Novartis oncology portfolio and therapeutic platforms
  
  

Basel, April 26, 2023 — Novartis will present new data from its oncology portfolio at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, including advancements in breast cancer, prostate cancer and lung cancer from more than 40 Novartis-sponsored and investigator-led trials. Primary results from the NATALEE trial evaluating Kisqali^® (ribociclib) plus endocrine therapy in patients with stage II and stage III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer at risk of cancer recurrence, regardless of nodal involvement, will be presented.

“We look forward to sharing the primary analysis from the Phase III NATALEE trial of Kisqali in the investigational setting in a broad population of patients with early-stage breast cancer at ASCO,” said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. “These promising data, together with other key updates, illustrate how we continue to advance our pipeline in oncology, with the potential to help address the significant unmet needs of patients living with cancer.”

Key highlights of data accepted by ASCO include:

Medicine	Abstract Title	Abstract Number/ Presentation Details
Kisqali® (ribociclib)*	Phase III NATALEE trial of ribociclib + endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer	Abstract #LBA500 Oral presentation: Friday, June 2, 2:45 – 5:45pm CDT
Kisqali® (ribociclib)*	Outcomes with first-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs physician’s choice combination chemotherapy (combo CT) by age in pre/perimenopausal patients (pts) with aggressive HR+/HER2- advanced breast cancer (ABC): A subgroup analysis of the RIGHT Choice trial	Abstract #1063 Poster available: Sunday, June 4, 8:00 – 11:00am CDT
Kisqali® (ribociclib)*	Ribociclib (RIB) vs. palbociclib (PAL) in patients (pts) with hormone receptor-positive/HER2-negative/HER2-Enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC): A head-to-head phase III study. HARMONIA SOLTI-2101 / AFT-58	Abstract #TPS1125 Poster available: Sunday, June 4, 8:00 – 11:00am CDT
Pluvicto® (lutetium Lu 177 vipivotide tetraxetan)	Building a predictive model for outcomes with [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer using VISION data: Preliminary results	Abstract #5028 Poster available: Saturday, June 3, 8:00 – 11:00am CDT
Pluvicto® (lutetium Lu 177 vipivotide tetraxetan)	Tumor dosimetry of [177Lu]Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer: results from the VISION trial sub-study	Abstract #5046 Poster available: Saturday, June 3, 8:00 – 11:00am CDT
JDQ443	KontRASt-01 update: Safety and efficacy of JDQ443 in KRAS G12C-mutated solid tumors including non-small cell lung cancer (NSCLC)	Abstract #9007  Oral presentation: Tuesday, June 6, 9:45am – 12:45pm CDT
PHE885	Updated phase I study results of PHE885, a T-Charge manufactured BCMA-directed CAR-T cell therapy, for patients (pts) with r/r multiple myeloma (RRMM)	Abstract #8004 Oral presentation: Saturday, June 3, 1:15 – 4:15pm CDT

Product Information
For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. We deliver high-value medicines that alleviate society’s greatest disease burdens through technology leadership in R&D and novel access approaches. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. About 103,000 people of more than 140 nationalities work together to bring Novartis products to nearly 800 million people around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library.
For questions about the site or required registration, please contact media.relations@novartis.com.

# # #

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

Novartis Media Relations E-mail: media.relations@novartis.com
Central			North America
Richard Jarvis	+41 79 584 2326		Julie Masow	+1 862 579 8456
Anja von Treskow Anna Schäfers	+41 79 392 9697 +41 79 801 7267		Michael Meo Mary Carmichael	+1 862 274 5414 +1 862 200 8344
			Marlena Abdinoor	+1 617 335 9525
Switzerland Satoshi Sugimoto	+41 79 619 2035
Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com
Central			North America
Samir Shah		+41 61 324 7944	Sloan Simpson		+1 862 345 4440
Nicole Zinsli-Somm		+41 61 324 3809	Parag Mahanti		+1 973 876 4912
Isabella Zinck		+41 61 324 7188

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.