Press Release: Novartis advances RLT innovation and reinforces leadership in prostate cancer, breast cancer and hematology with new data at ASCO and EHA

-- Pluvicto(R) PSMAddition oral presentation to highlight efficacy outcomes

by disease volume and de novo/recurrent metastatic hormone-sensitive

prostate cancer

-- Kisqali(R) NATALEE oral presentation to report prognostic and predictive

impact of gene expression from largest biomarker CDK4/6i trial dataset

-- Scemblix(R) ASC4FIRST oral presentation to feature longer-term 144-week

efficacy, safety and tolerability data in first-line Ph+ CML-CP

-- New Novartis pipeline data, including Phase 3 ianalumab in ITP as well as

Phase 1 actinium-based radioligand therapy, also to be presented

Basel, May 21, 2026 -- Novartis will present data from more than 65 company or investigator sponsored abstracts at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress.

"We are excited about sharing our latest advancements in radioligand therapy with new Pluvicto data and early insights from our actinium-based RLT," said Mark Rutstein, MD, Global Head, Oncology Development, Novartis. "With a legacy of bold science, our Kisqali and Scemblix data offer continued evidence of how we meaningfully move cancer treatment forward for patients."

Key ASCO data highlights include:

Abstract Title Abstract Number/

Presentation Details

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

Subgroup Analyses by Disease Volume and De Novo/Recurrent Abstract # 5020

mHSPC in the PSMAddition Study of [(177) Lu]Lu-PSMA-617 Rapid Oral

(225) Ac-PSMA-617 May 31, 4:30pm -- 6:00pm CDT

AcTION: Phase 1 Study of [(225) Ac]Ac-PSMA-617 (225Ac-PSMA-617) Abstract # 5010

in Men With Metastatic Castration-resistant Prostate Oral

Cancer (mCRPC) With or Without Prior [(177) Lu]Lu-PSMA June 1, 3:00pm -- 4:30pm CDT

(177Lu-PSMA) Radioligand Therapy (RLT)

Scemblix (asciminib)

ASC4FIRST wk 144 Analysis: Efficacy and Safety and Abstract #6583

Tolerability With Asciminib (ASC) vs Investigator-Selected Poster

Tyrosine Kinase Inhibitors (IS TKIs) in Newly Diagnosed June 1, 9:00am -- 12:00pm CDT

(ND) chronic myeloid leukemia in Chronic Phase (CML-CP)

Kisqali (ribociclib)

Prognostic and Predictive Impact of Baseline Gene Abstract #501

Expression (Exp) in the NATALEE Trial of Adjuvant Oral

(Adj) Ribociclib (RIB) + Nonsteroidal Aromatase Inhibitor May 30, 1:15pm -- 4:15pm CDT

(NSAI) in HR+/HER2- Early Breast Cancer (EBC)

Real-World (RW) Post-Progression Outcomes Following Abstract #1073

First-Line (1L) Ribociclib (RIB) + Aromatase Inhibitor Poster

(AI) Versus AI Alone in African American and Low Socio-Economic June 1, 1:30pm -- 4:30pm CDT

Status (SES) Patients (Pts) With Hormone Receptor--Positive/Human

Epidermal Growth Factor Receptor 2--Negative (HR+/HER2--)

Metastatic Breast Cancer (MBC) in the US

Real-World (RW) Post-Progression Outcomes After First-Line Abstract # e13044

(1L) Treatment With Ribociclib + an Aromatase Inhibitor Online publication

(AI) vs AI Alone in US Patients With Hormone Receptor--Positive/Human

Epidermal Growth Factor Receptor 2--Negative (HR+/HER2--)

Metastatic Breast Cancer (MBC)

Key EHA data highlights include:

Abstract Title Abstract Number/ Presentation

Details

Scemblix (asciminib)

ASC4FIRST wk 144 Analysis: Continued Superior Efficacy Abstract # S160

and Favorable Safety of Asciminib vs Investigator-Selected Oral

Tyrosine Kinase Inhibitors in Newly Diagnosed Chronic June 11, 4:45pm -- 6:00pm CEST

Phase Chronic Myeloid Leukemia

Ianalumab (VAY736)

Effect of Ianalumab Plus Eltrombopag on Patient-Reported Abstract # PF1340

Outcomes in Primary Immune Thrombocytopenia: Results Poster

From the VAYHIT2 Phase 3 Trial June 12, 6:45pm -- 7:45pm CEST

Pelabresib (DAK539)

Pelabresib Monotherapy in Myelofibrosis After Janus Abstract # PS1987

Kinase Inhibitor Failure: Results From Arm 1 of the Poster

Open-Label, Phase 2 MANIFEST Study June 13, 6:45pm -- 7:45pm CEST

Rapcabtagene autoleucel (YTB323)

Safety, Cellular Kinetics and Early Efficacy of Rapcabtagene Abstract # PF1241

Autoleucel (YTB323), a Rapidly Manufactured Autologous Poster

CD19 CAR-T Therapy, in Severe, Refractory Autoimmune June 12, 6:45pm -- 7:45pm CEST

Diseases

Fabhalta(R) (iptacopan)

Iptacopan demonstrates sustained efficacy and safety Abstract #PS1788

in paroxysmal nocturnal hemoglobinuria: up to 4 years Poster

of follow-up in patients from APPLY, APPOINT and roll-over June 13, 6:45pm -- 7:45pm

extension program CEST

Long-term hematologic control and safety in patients Abstract # PS1797

with paroxysmal nocturnal hemoglobinuria treated with Poster

iptacopan: 6-year follow-up from phase 2 studies and June 13, 6:45pm -- 7:45pm

roll-over extension program CEST

Novartis in oncology

The Novartis oncology strategy focuses on people living with cancer and those who care for them, from loved ones to clinical care teams, including their providers. For the past 30+ years, the aim has been to extend and improve lives by discovering differentiated, innovative and practice-changing medicines for patients.

As Novartis reimagines medicine, it collaborates with a wide range of patient advocacy groups and supports education, early cancer screening and diagnosis. With a broad research and development portfolio across solid tumors, hematology and radioligand therapy (RLT), Novartis is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," or similar expressions, or by express or implied discussions regarding: potential new products; potential new indications for existing products; potential product launches or potential future revenues from any such products; results of ongoing clinical trials; or potential future, pending or announced transactions; potential future sales or earnings; strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or our capital structure. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations could be affected by, among other things, uncertainties concerning: global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the success of our key products, commercial priorities and strategy; research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence, and new business models; potential significant breaches of information security or disruptions of our information technology systems; actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future global exchange rates; future demand for our products; and other risks and factors referred to in Novartis AG's most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

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