
Novartis data underscore pioneering scientific innovation in Hematology and Oncology at ASH and SABCS
25.11.2025 07:15:00 CET | GlobeNewswire by notified | Press release
- Positive results from ianalumab pivotal Phase III trial in ITP patients previously treated with corticosteroids to be presented as late-breaker
- Scemblix data across clinical and real-world settings offer new evidence informing CML care amid evolving patient needs
- 96-week pelabresib Phase III data represent longest follow-up of first-line myelofibrosis patients in randomized combination trial
- Kisqali NATALEE and MONALEESA data add to evidence of long-term benefits for early and metastatic breast cancer patients
Basel, November 25, 2025 – Novartis will present data from over 70 abstracts, including investigator-initiated trials at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium® (SABCS). Featured among these latest advances in hematology and oncology are 11 oral presentations, with the Phase III VAYHIT2 trial for ianalumab in immune thrombocytopenia (ITP) accepted as a late-breaker abstract.
“For decades, Novartis has redefined the future of hematology and oncology, and we’re building on that foundation with compelling new data presented at ASH and SABCS,” said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. “These data underscore how we seek to set new standards for transformative care, with the aim of turning cutting-edge innovation into meaningful impact for patients.”
Key highlights of data accepted by ASH include:
| Abstract Title | Abstract Number/ Presentation Details |
| Ianalumab (VAY736) | |
| Primary results from VAYHIT2, a randomized, double-blind, Phase 3 trial of ianalumab plus eltrombopag versus placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatment | Abstract #LBA-2 Oral Presentation December 9, 7:45 – 8:00 am ET |
| Secondary analysis results from VAYHIT3, a Phase 2 study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapy | Abstract #844 Oral Presentation December 8, 3:30 – 3:45 pm ET |
| Scemblix® (asciminib) | |
| Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysis | Abstract #1997 Poster Presentation December 6, 5:30 – 7:30 pm ET |
| Improved long-term tolerability with asciminib (ASC) vs investigator-selected (IS) tyrosine kinase inhibitors (TKIs) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Week 96 exploratory analysis of the phase 3 ASC4FIRST trial | Abstract #5549 Poster Presentation December 8, 6:00 – 8:00 pm ET |
| Asciminib (ASC) in chronic myeloid leukemia in chronic Phase (CML-CP): Efficacy and safety results of the Phase 2 ASC2ESCALATE trial in the cohort of patients (pts) with 1 prior tyrosine kinase inhibitor (TKI) | Abstract #906 Oral Presentation December 8, 4:00 – 4:15 pm ET |
| A comparison of real-world outcomes of asciminib versus ATP-competitive tyrosine kinase inhibitors as second-line treatment in patients with chronic myeloid leukemia in chronic phase | Abstract #724 Oral Presentation December 7, 5:15 – 5:30 pm ET |
| Pelabresib (DAK539) | |
| Durable efficacy and long-term safety with pelabresib plus ruxolitinib in JAK Inhibitor–Naive myelofibrosis: 96-week Results from the Phase III MANIFEST-2 study | Abstract #910 Oral Presentation December 8, 3:30 – 3:45pm ET |
| Rapcabtagene autoleucel (YTB323) | |
| Rapcabtagene autoleucel (YTB323) for patients with first line high-risk large B-cell lymphoma: phase II interim results | Abstract #670 Oral Presentation December 7, 5:15 – 5:30 pm ET |
| Fabhalta® (iptacopan) | |
| Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin increases in patients with paroxysmal nocturnal hemoglobinuria with baseline hemoglobin levels 10 to <12 g/dL on anti-C5 therapy: Subgroup analysis of the APPULSE-PNH Phase 3b trial | Abstract #4981 Poster Presentation December 8, 6:00 – 8:00 pm ET |
| Long-term safety and efficacy of iptacopan in patients with paroxysmal nocturnal hemoglobinuria: 4- and 5-year follow-up of patients from phase 2 studies who entered the roll-over extension program | Abstract #3198 Poster Presentation December 7, 6:00 – 8:00 pm ET |
| The 2-year efficacy and safety of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria with a history of aplastic anemia on concomitant immunosuppressive therapy who entered the roll-over extension program | Abstract #4978 Poster Presentation December 8, 6:00 – 8:00 pm ET |
Key highlights of data accepted by SABCS include:
| Kisqali® (ribociclib) | |
| Pooled analysis of patients (pts) treated with 1st-line (1L) ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) studies: long-term progression-free survival (PFS) | Abstract # PD5-10 Poster Spotlight Presentation December 11, 8:09 – 8:12 am CST |
| Five-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC) | Abstract # PS3-09-08 Poster Presentation December 11, 12:30 – 2:00 pm CST |
| Progression-free survival (PFS) and overall survival (OS) results from the phase 3 MONALEESA-3 trial of postmenopausal patients with hormone receptor–positive (HR+)/HER2-negative (HER2−) advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL): A subgroup analysis of patients with invasive lobular carcinoma (ILC) | Abstract # PS1-10-27 Poster Presentation December 10, 12:30 – 2:00 pm CST |
| Ribociclib drug-drug interaction and concomitant medication management in early and advanced breast cancer patients | Abstract # PS3-09-15 Poster Presentation December 11, 12:30 – 2:00 pm CST |
| Real-world patient (pt) and caregiver experiences with breast cancer (BC) risk of recurrence (ROR) in the US: Results of an Online Survey and Social Media Analysis | Abstract # PS1-04-17 Poster Presentation December 10, 12:30 – 2:00 pm CST |
| Repower: a real-world noninterventional study of outcomes and experiences in patients with hormone receptor-positive (HR+)/human epidermal growth fact receptor 2-negative (HER2−) early breast cancer (EBC) treated with an adjuvant cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) plus endocrine therapy (ET) | Abstract # PS3-08-27 Poster Presentation December 11, 12:30 – 2:00 pm CST |
Product Information
For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.
Novartis in hematology
Our legacy in hematology runs deep, shaped by over 25 years of progress, partnerships and a commitment to keep asking questions, challenging norms and striving for better answers in a uniquely complex field. In the past two decades, we have delivered more than 10 medicines across more than 15 blood cancers and serious blood disorders including leading the era of targeted therapies in cancer and bringing the first CAR-T therapy to patients.
Innovation in hematology has brought significant progress, yet patients and clinicians continue to face persistent challenges. We’re forging the future of hematology, powered by our foundation in scientific discovery to deliver meaningful change for patients with unmet needs.
Novartis in breast cancer
For over 30 years, Novartis has been at the forefront of driving scientific advancements for individuals affected by breast cancer and enhancing clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease.
Disclaimer
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About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.
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