On November 22, 2022 Novartis reported that it 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) (Free ASH Whitepaper) Annual Meeting, December 10-13 (Press release, Novartis, NOV 22, 2022, https://www.novartis.com/us-en/news/media-releases/novartis-highlights-scientific-advances-kisqali-iptacopan-scemblix-and-ytb323-data-sabcs-and-ash [SID1234624357]). 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.
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"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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper):
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
Product Information
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