Press Release: New Novartis data at ASCO and EHA showcase momentum of pioneering portfolio with promising pipeline

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-- NATALEE subanalysis evaluates Kisqali in pre-menopausal early breast

cancer patients, amid rising diagnosis rates in younger patients

-- Pluvicto analysis and Scemblix ASC4START primary endpoint results provide

insights into use in earlier settings

-- Fabhalta APPULSE-PNH full results build on Phase III program, reporting

new data from expanded PNH population in adults switching from anti-C5

-- Ianalumab Phase II data in immune thrombocytopenia and longer-term

pelabresib Phase III data in myelofibrosis show breadth of pipeline in

hematologic diseases

Basel, May 15, 2025 -- Novartis will present data from 60 company or investigator sponsored abstracts that have the potential to change clinical practice, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2025 Congress.

"The breadth of our oncology and hematology portfolio -- anchored by Kisqali, Pluvicto, Scemblix and Fabhalta -- demonstrates our leadership in both solid tumors and hematologic diseases," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "At ASCO and EHA, we will present new data on these priority medicines as well as updates from our pipeline and our industry-leading radioligand therapy research."

Novartis will also highlight its US partnerships with the National Football League (NFL), Alliance for Breast Cancer Policy, and ZERO Prostate Cancer, which encourage people to make proactive decisions about their health and advance patient-centered policy solutions to help improve outcomes.

"We're witnessing a profound shift in how people move through their cancer journey, with cancer diagnoses occurring at younger ages and, simultaneously, older patients living longer and approaching aging with new vigor," said Victor Bultó, President, US, Novartis. "As a leader in driving medical advances in oncology, we have the responsibility to also make a difference in areas beyond treatment innovation. By partnering across the ecosystem, our goal is to advance the conversation around earlier detection and meet the evolving needs of this next generation of cancer patients."

Key highlights of data accepted by ASCO include:

Medicine Abstract Title Abstract Number/ Presentation

Details

Kisqali(R) Efficacy and safety of ribociclib (RIB) + nonsteroidal Abstract #516

(ribociclib)* aromatase inhibitor (NSAI) in NATALEE: Analysis across Rapid Oral

menopausal status and age June 1, 8:00 -- 9:30am CDT

Kisqali(R) Real-world (RW) analysis of characteristics and risk Abstract #527

(ribociclib) of recurrence (ROR) in Black patients (pts) with HR+/HER2- Poster Presentation

early breast cancer (EBC) eligible for NATALEE June 2, 9:00am -- 12:00pm CDT

Kisqali(R) Adjuvant WIDER: A phase 3b trial of ribociclib (RIB) Abstract #TPS617

(ribociclib) + endocrine therapy (ET) as adjuvant treatment (tx) Poster Presentation

in a close-to-clinical-practice patient (pt) population June 2, 9:00am -- 12:00pm CDT

with HR+/HER2- early breast cancer (EBC)

Kisqali(R) First-line (1L) ribociclib (RIB) + endocrine therapy Abstract #1069

(ribociclib) (ET) vs combination chemotherapy (combo CT) in clinically Poster Presentation

aggressive hormone receptor (HR)+/HER2- advanced breast June 2, 9:00am -- 12:00pm CDT

cancer (ABC): A subgroup analysis of patients (pts)

with or without liver metastases (mets) from RIGHT

Choice

Scemblix(R) Efficacy and safety of asciminib (ASC) in patients Abstract #6516

(asciminib) (pts) with chronic-phase chronic myeloid leukemia Rapid Oral

(CML-CP) after 1 tyrosine kinase inhibitor (TKI): May 30, 1:00 -- 2:30pm CDT

Interim analysis (IA) of the phase 2 ASC2ESCALATE

trial

Scemblix(R) Primary endpoint results of the phase 3b ASC4START Abstract #6501

(asciminib) trial of asciminib (ASC) vs nilotinib (NIL) in newly Oral Presentation

diagnosed chronic phase chronic myeloid leukemia (CML-CP): June 2, 3:00 -- 6:00pm CDT

Time to treatment discontinuation due to adverse events

(TTDAE)

Pluvicto(R) Clinical outcomes of prompt versus deferred 177Lu-PSMA-617 Abstract #e17030

(lutetium Lu 177 vipivotide tetraxetan) initiation for metastatic castration-resistant prostate Online Publication

cancer (mCRPC) based on prior androgen receptor pathway

inhibitor (ARPI) and taxane chemotherapy exposure:

a real-world PRostatE Cancer dISease observatION (PRECISION)

data platform analysis

Pluvicto(R) Real-world outcomes among patients with metastatic Abstract #e17035

(lutetium Lu 177 vipivotide tetraxetan) castration-resistant prostate cancer (mCRPC) receiving Online Publication

guideline-recommended therapies after treatment with

177Lu-PSMA-617: a real-world PRostatE Cancer dISease

observatION (PRECISION) data platform analysis

Pluvicto(R) PSMA-delay castration (DC): An open-label, multicenter, Abstract #TPS5127

(lutetium Lu 177 vipivotide tetraxetan) randomized phase 3 study of [177Lu]Lu-PSMA-617 versus Poster Presentation

observation in patients with metachronous PSMA-positive June 2, 9:00am -- 12:00pm CDT

oligometastatic prostate cancer (OMPC)

Key highlights of data accepted by EHA include:

Medicine Abstract Title Abstract Number/ Presentation

Details

Fabhalta(R) APPULSE-PNH: Oral iptacopan monotherapy demonstrates Abstract #S183

(iptacopan) clinically meaningful hemoglobin (Hb) increases in Oral Presentation

patients (pts) with paroxysmal nocturnal hemoglobinuria June 13, 5:00 -- 6:15pm CEST

(PNH) and Hb >=10 g/dL on anti-C5 therapy

Fabhalta(R) The 2-year safety and efficacy of iptacopan monotherapy Abstract #PF660

(iptacopan) in patients with paroxysmal nocturnal hemoglobinuria Poster Presentation

(PNH) from APPLY- and APPOINT-PNH studies who entered June 13, 6:30 -- 7:30pm CEST

the roll-over extension program (REP)

Scemblix(R) Asciminib (ASC) shows superior tolerability vs nilotinib Abstract #S166

(asciminib) (NIL) in newly diagnosed chronic myeloid leukemia Oral Presentation

in chronic phase (CML-CP): Primary endpoint results June 13, 5:00 -- 6:25pm CEST

of the phase (Ph) 3b ASC4START trial

Scemblix(R) Improved patient-reported outcomes (PROs) with asciminib Abstract #PS1588

(asciminib) (ASC) vs investigator-selected tyrosine kinase inhibitors Poster Presentation

(IS-TKIs) in newly diagnosed chronic myeloid leukemia June 14, 6:30 -- 7:30pm CEST

(CML): ASC4FIRST wk 48 analysis

Scemblix(R) Interim analysis (IA) results from ASC2ESCALATE support Abstract #PF595

(asciminib) asciminib (ASC) as a treatment (Tx) option in chronic-phase Poster Presentation

chronic myeloid leukemia (CML-CP) after 1 tyrosine June 13, 6:30 -- 7:30pm CEST

kinase inhibitor (TKI)

Pelabresib Pelabresib in combination with ruxolitinib for janus Abstract #S223

(DAK539) kinase inhibitor-naive patients with myelofibrosis: Oral Presentation

72-week follow-up with long-term efficacy outcomes June 12, 5:00 -- 6:15pm CEST

of the phase III MANIFEST-2 study

Ianalumab A Phase 2 Study of Ianalumab in patients with primary Abstract #S312

(VAY736) immune thrombocytopenia previously treated with at Oral Presentation

least two lines of therapy (VAYHIT3) June 15, 11:00am -- 12:15pm CEST

Rapcabtagene autoleucel Rapcabtagene Autoleucel (YTB323) in patients with Abstract #PF1152

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May 15, 2025 09:00 ET (13:00 GMT)