Ianalumab

Positive results from ianalumab pivotal Phase III trial in ITP patients previously treated with corticosteroids to be presented as late-breakerScemblix 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 trialKisqali 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 treatmentAbstract #LBA-2Oral PresentationDecember 9, 7:45 – 8:00 am ETSecondary analysis results from VAYHIT3, a Phase 2 study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapyAbstract #844Oral PresentationDecember 8, 3:30 – 3:45 pm ETScemblix® (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 analysisAbstract #1997Poster PresentationDecember 6, 5:30 – 7:30 pm ETImproved 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 trialAbstract #5549Poster PresentationDecember 8, 6:00 – 8:00 pm ETAsciminib (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 #906Oral PresentationDecember 8, 4:00 – 4:15 pm ETA 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 phaseAbstract #724Oral PresentationDecember 7, 5:15 – 5:30 pm ETPelabresib (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 studyAbstract #910Oral PresentationDecember 8, 3:30 – 3:45pm ETRapcabtagene autoleucel (YTB323)Rapcabtagene autoleucel (YTB323) for patients with first line high-risk large B-cell lymphoma: phase II interim resultsAbstract #670Oral PresentationDecember 7, 5:15 – 5:30 pm ETFabhalta® (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 trialAbstract #4981Poster PresentationDecember 8, 6:00 – 8:00 pm ETLong-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 programAbstract #3198Poster PresentationDecember 7, 6:00 – 8:00 pm ETThe 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 programAbstract #4978Poster PresentationDecember 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 # PD5-10Poster Spotlight PresentationDecember 11, 8:09 – 8:12 am CSTFive-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 # PS3-09-08Poster PresentationDecember 11, 12:30 – 2:00 pm CSTProgression-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 PresentationDecember 10, 12:30 – 2:00 pm CSTRibociclib drug-drug interaction and concomitant medication management in early and advanced breast cancer patientsAbstract # PS3-09-15Poster PresentationDecember 11, 12:30 – 2:00 pm CSTReal-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 # PS1-04-17Poster PresentationDecember 10, 12:30 – 2:00 pm CSTRepower: 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 # PS3-08-27Poster PresentationDecember 11, 12:30 – 2:00 pm CST Product InformationFor full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.Novartis in hematologyOur 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. 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Novartis has broad disease aspirations for ianalumab, the anti-BAFF monoclonal antibody (mAb) it gained via its $2.9-billion takeout of MorphoSys. With regulatory filings on track for an early 2026 submission in Sjögren's disease, the Swiss pharma has turned its attention to its next indication of interest, revealing updated Phase III data on Monday to make the mAb's case in immune thrombocytopenia (ITP).In August, Novartis had reported that ianalumab met its primary and key secondary endpoints in the VAYHIT2 study, which enrolled 153 adults with primary ITP and platelet counts <30 G/L following corticosteroid treatment failure. Detailed results were shared Monday in a late-breaking abstract ahead of the American Society of Hematology (ASH) meeting (see – Spotlight On: Late-breakers to watch at ASH 2025).The trial randomised participants to receive four monthly intravenous infusions of ianalumab at either a 3 mg/kg or 9 mg/kg dosage, or placebo, given on top of the thrombopoietin receptor agonist eltrombopag. On the study's main measure of time to treatment failure (TTF) — defined as platelet count <30 G/L after 8 weeks, need for rescue therapy after 8 weeks, new ITP treatment at any time, inability to taper/stop eltrombopag or death — patients receiving the 9 mg/kg dose achieved a median TTF of 13 months, significantly longer than the 4.7 months seen on placebo. In addition, 62% of high-dose ianalumab recipients had a stable response at 6 months versus 39.2% of those in the placebo group, a statistically significant finding for the key secondary endpoint. Stable response was defined as having ≥75% of platelet counts between weeks 19 and 25 being ≥50x109/L without rescue or new ITP treatment.The mAb also reduced fatigue, helped patients taper off eltrombopag, and delayed the need for subsequent therapy, Novartis reported. On the safety front, ianalumab was well tolerated, with no increase in infection risk. The adverse event (AE) rates were similar between the two arms, with no treatment-related AEs leading to ianalumab discontinuation. "Ianalumab may be disease-modifying when used early in the course of ITP," abstract authors concluded.Meanwhile, ianalumab is also being evaluated in other autoimmune indications including systemic lupus erythematosus, lupus nephritis, warm autoimmune haemolytic anaemia, and diffuse cutaneous systemic sclerosis, and analysts estimates the drug could generate peak annual sales of $5 billion.