Novartis highlights scientific advances with Kisqali, iptacopan, Scemblix and YTB323 data at SABCS and ASH

• First data to be presented as a late-breaker abstract from global pivotal APPLY-PNH trial of investigational oral monotherapy iptacopan in paroxysmal nocturnal hemoglobinaria (PNH), a rare and serious complement-mediated blood disorder
  
  
• New data evaluating the superiority of first-line (1L) Kisqali^® plus endocrine therapy vs. combination chemotherapy in pre-menopausal patients with HR+/HER2- metastatic breast cancer with aggressive disease, including patients with visceral disease
  
  
• New analysis from Scemblix^® ASCEMBL trial on factors of response in pre-treated patients with Ph+ CML-CP and trial-in-progress update from ASC4FIRST, investigating Scemblix in newly diagnosed patients
  
  
• New follow-up data from the ongoing Phase I trial with our next generation CAR-T cell therapy rapcabtagene autoleucel (YTB323) in r/r DLBCL using the Novartis-developed T-Charge^TM platform

EAST HANOVER, N.J., Nov. 22, 2022 /PRNewswire/ -- Novartis will present data on the latest advancements in breast cancer and hematology at the 2022 San Antonio Breast Cancer Symposium (SABCS), December 6-10, and the American Society of Hematology (ASH) Annual Meeting, December 10-13. More than 130 abstracts, from both Novartis-sponsored trials and investigator-initiated trials using Novartis compounds, were accepted at the meetings, reinforcing Novartis leadership and innovation in priority oncology therapeutic areas.

"Novartis continues to pioneer critical medicines that redefine treatment goals in cancer and non-malignant hematology," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "At SABCS and ASH this year, we'll share new clinically-relevant and patient-focused data for Kisqali in aggressive metastatic breast cancer, and for Scemblix and YTB323 in life-threatening blood cancers, and potentially practice-changing data for iptacopan in PNH, underscoring the strength of our promising pipeline."

Key highlights of data accepted by SABCS: 

Key highlights of data accepted by ASH: 

Product Information 
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications. 

For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartisoncology.com/news/product-portfolio. 

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," "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
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation – an affiliate of 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. Novartis employs nearly 14,500 people in the United States. For more information, please visit https://www.novartis.us

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

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SOURCE Novartis US

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