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

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  • 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-ChargeTM platform

Basel, November 22, 2022 — 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:

MedicineAbstract TitleAbstract Number/ Presentation Details 
Kisqali® (ribociclib)* 

Primary results from the randomized Phase II RIGHT Choice trial of premenopausal patients with aggressive HR+/HER2− advanced breast cancer treated with ribociclib + endocrine therapy vs physician’s choice combination chemotherapy  Abstract #GS1-10

Oral Presentation 

Tuesday, December 6 

5:15 PM ET 

Kisqali® (ribociclib)*  Pooled analysis of post-progression treatments after first-line ribociclib + endocrine therapy in patients with HR+/HER2- advanced breast cancer in the MONALEESA-2, -3, and -7 studies  Abstract #P4-01-42

Poster Presentation 

Thursday, December 8

8:00 AM ET

Kisqali® (ribociclib)* 

Pooled gene expression analysis and association with treatment response in patients with HR+/HER2− advanced breast cancer in the MONALEESA-2, -3, and -7 trials  Abstract #PD17-08

Poster Discussion 

Friday, December 9

8:00 AM ET

Piqray® (alpelisib) 

Long-term and very-long-term disease control in patients from BYLieve study cohort A with PIK3CA-Mutant, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer  Abstract #PD13-06

Poster Discussion 

Thursday, December 8

6:00 PM ET
Piqray® (alpelisib) 

Metformin (MET) for the prevention of alpelisib (ALP)-related hyperglycemia (HG) in PIK3CA-mutated, hormone receptor-positive (HR[+]) HER2-negative (HER2[-]) advanced breast cancer (ABC): The METALLICA study Abstract #PD8-02

Poster Discussion 

Wednesday, December 7

6:00 PM ET

Key highlights of data accepted by ASH:

MedicineAbstract TitleAbstract Number/ Presentation Details 
Iptacopan (LNP023) 

Oral monotherapy with iptacopan, a proximal complement inhibitor of factor B, has superior efficacy to intravenous terminal complement inhibition with standard of care Eculizumab or Ravulizumab and favorable safety in patients with paroxysmal nocturnal hemoglobinuria and residual anemia: Results from the randomized, active-comparator-controlled, open-label, multicenter, Phase III APPLY-PNH study Abstract #LBA-2

Oral Presentation

Tuesday, December 13

9:15 AM ET

Iptacopan (LNP023)  Dose–exposure–response relationships of biomarkers and efficacy measures with iptacopan, a complement factor B inhibitor, in patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH) with or without concomitant anti-C5 therapy Abstract #2571

Poster Presentation

Sunday, December 11

6:00 – 8:00 PM ET
Scemblix® (asciminib) 

Efficacy and safety results from ASC4MORE, a randomized study of asciminib (ASC) add-on to imatinib (IMA), continued IMA, or switch to nilotinib (NIL) in patients (pts) with chronic-phase chronic myeloid leukemia (CML-CP) not achieving deep molecular responses (DMRs) with ≥1 year of IMA   Abstract #80

Oral Presentation 

Saturday, December 10 

9:45 AM ET 

Scemblix® (asciminib) 

Dynamics of response and response factors in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after ≥2 prior tyrosine kinase inhibitors (TKIs) in the phase 3 ascembl study   Abstract #3008

Poster Presentation 

Sunday, December 11 

6:00 PM - 8:00 PM ET 

Scemblix® (asciminib) 

ASC4FIRST: A Phase III study of asciminib vs investigator-selected tyrosine kinase inhibitor in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP)   Abstract #3012

Poster Presentation 

Sunday, December 11 

6:00 PM - 8:00 PM ET 

Scemblix® (asciminib) 

ASC4START: A Phase IIIb, open-label, randomized study of tolerability and efficacy of asciminib versus nilotinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase   Abstract #3021

Poster Presentation 

Sunday, December 11 

6:00 PM – 8:00 PM ET 
Kymriah® 

(tisagenlecleucel) 
Long-term clinical outcomes and correlative efficacy analyses in patients (pts) with relapsed/refractory follicular lymphoma (r/r FL) treated with tisagenlecleucel in the ELARA trial   Abstract #608

Oral Presentation 

Sunday, December 11 

4:45 PM ET  
Kymriah® 

(tisagenlecleucel) 

Real-world outcomes for patients with relapsed or refractory (r/r) aggressive B-cell non-Hodgkin's lymphoma (aBNHL) treated with commercial tisagenlecleucel: subgroup analyses from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry Abstract #656

Oral Presentation 

Sunday, December 11 

4:45 PM ET 

YTB323

(rapcabtagene autoleucel)
YTB323 (rapcabtagene autoleucel) demonstrates durable efficacy and a manageable safety profile in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL): Phase I study update  Abstract #439

Oral Presentation 

Sunday, December 11  

9:30 AM ET 

Jakavi® (ruxolitinib)  Ruxolitinib in pediatric patients with treatment-naive or steroid refractory acute graft versus host disease: Primary findings from the Phase I/II REACH4 study  Abstract #572

Oral Presentation 

Sunday, December 11  

12:15 PM ET 
Sabatolimab 

(MBG453) 

Primary results of STIMULUS-MDS1: A randomized, double-blind, placebo-controlled Phase II study of TIM-3 inhibition with sabatolimab added to hypomethylating agents (hmas) in adult patients with higher-risk myelodysplastic syndromes (MDS) 

Abstract #853

Oral Presentation 

Monday, December 12 

2:45 PM ET 

Sabatolimab 

(MBG453) 

Disease characteristics and International Prognostic Scoring Systems (IPSS, IPSS-R, IPSS-M) in adult patients with higher-risk myelodysplastic syndromes (MDS) participating in two randomized, double-blind, placebo-controlled studies with intravenous sabatolimab 

added to hypomethylating agents (HMA) (STIMULUS-MDS1 and MDS2) 

Abstract #559

Oral Presentation

Sunday, December 11

12:00 PM ET

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,” “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 108,000 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

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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.

Novartis Media Relations
E-mail: media.relations@novartis.com

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