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

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:

Medicine	Abstract Title	Abstract 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:

Medicine	Abstract Title	Abstract 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

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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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