Press Release: Novartis to unveil new data at ASCO and EHA from its robust portfolio, including overall survival in prostate and breast cancer

-- Overall survival and radiographic PFS from phase III study of

investigational radioligand therapy 177Lu-PSMA-617 VISION trial of

patients with metastatic castration-resistant prostate cancer to be

presented at ASCO plenary

-- New Kisqali (ribociclib)* overall survival data from extended follow-up

of MONALEESA-3 trial in patients with postmenopausal HR+/HER2- advanced

or metastatic breast cancer

-- Phase II results for oral, targeted factor B inhibitor iptacopan (LNP023)

as first line monotherapy in anti-C5 treatment-naïve patients with

paroxysmal nocturnal hemoglobinuria

-- Updated efficacy and safety results from pivotal ELARA trial of

Kymriah(R) (tisagenlecleucel) in relapsed or refractory follicular

lymphoma

-- Data demonstrate Novartis innovation for patients and strength of its

four therapeutic platforms: targeted therapies, radioligand therapy, cell

and gene therapy and immunotherapy

Basel, May 19, 2021 -- Novartis will present new data from its portfolio

of approved and investigational targeted, radioligand, cell and gene and

immunotherapies at the upcoming 2021 American Society of Clinical

Oncology (ASCO) Annual Meeting and the 2021 European Hematology

Association (EHA) Virtual Congress. More than 110 abstracts, including

Novartis-sponsored and investigator-initiated trials, will be presented

at the meetings.

"Our bold ambition is to extend and improve the lives of those living

with cancer and serious blood disorders, and ultimately find cures,"

said Susanne Schaffert, PhD, President, Novartis Oncology. "These

exciting data from across our four therapeutic platforms illustrate how

we are uniquely positioned to deliver transformative innovations that

may bring renewed hope for patients."

Key highlights of data accepted by ASCO:

-- Efficacy and safety results from Phase III VISION study of

investigational targeted radioligand therapy 177Lu-PSMA-617

-- Phase 3 study of 177Lu-PSMA-617 in patients with metastatic

castration-resistant prostate cancer (VISION) [Abstract #LBA4;

oral presentation (plenary): Sunday, June 6, 1:00 PM EDT]

-- Kisqali(R) (ribociclib)* overall survival analysis from MONALEESA-3

-- Updated overall survival (OS) results from the Phase III

MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2-

advanced breast cancer (ABC) treated with fulvestrant (FUL) +/-

ribociclib (RIB) [Abstract #1001; oral presentation: Saturday,

June 5, 1:30 PM EDT]

-- Piqray(R) (alpelisib) long-term disease control data from SOLAR-1

-- Long-term (LT) Disease Control in Patients (pts) With Hormone

Receptor-Positive (HR+), PIK3CA-Altered Advanced Breast Cancer

(ABC) Treated With Alpelisib (ALP) + Fulvestrant (FUL)

[Abstract #1054; poster session: Friday, June 4, 9:00 AM EDT]

-- Kymriah(R) (tisagenlecleucel) updated efficacy and safety results from

Phase II ELARA trial in patients with relapsed or refractory follicular

lymphoma

-- Efficacy and Safety of Tisagenlecleucel (Tisa-cel) in Adult

Patients (Pts) With Relapsed/Refractory Follicular Lymphoma (r/r

FL): Primary Analysis of the Phase 2 ELARA Trial [ASCO: Abstract

#7508; oral presentation: Monday, June 7, 11:30 AM EDT] / [EHA

encore: Abstract #S210; oral presentation: Friday, June 11, 9:00

AM CEST]

-- Investigational agent tislelizumab** RATIONALE 302 pivotal data in

advanced/unresectable metastatic esophageal squamous cell carcinoma and

Phase II data in patients with MSI-H or dMMR solid tumors

-- RATIONALE 302: Randomized, phase 3 study of tislelizumab versus

chemotherapy as second-line treatment for advanced

unresectable/metastatic esophageal squamous cell carcinoma

[Abstract #4012; poster discussion: Friday, June 4, 9:00 AM EDT]

-- A phase 2 study of tislelizumab monotherapy in patients with

previously treated, locally advanced unresectable or metastatic

microsatellite instability-high/mismatch repair deficient solid

tumors [Abstract #2569; poster discussion: Friday, June 4, 9:00 AM

EDT]

-- Early data demonstrating innovation in solid tumors with novel assets

TNO155 and NIS793; further combination studies and NIS793 Phase III

planned to start later this year

-- Initial results from a dose finding study of TNO155, a SHP2

inhibitor, in adults with advanced solid tumors [Abstract #3005;

oral abstract: Friday, June 4, 11:00 AM EDT]

-- Phase Ib study of the anti-TGF- monoclonal antibody (mAb)

NIS793 combined with spartalizumab (PDR001), a PD-1 inhibitor, in

patients (pts) with advanced solid tumors [Abstract #2509; poster

session: Friday, June 4, 9:00 AM EDT]

-- Analysis of pyrexia-related and efficacy outcomes with new pyrexia

management algorithm in patients with stage III BRAF-mutation positive

melanoma treated with adjuvant Tafinlar(R) (dabrafenib) and Mekinist(R)

(trametinib)

-- Improved pyrexia-related outcomes associated with an adapted

pyrexia adverse event (AE) management algorithm in patients (pts)

treated with adjuvant dabrafenib + trametinib (dab + tram):

Primary results of COMBI-APlus [Abstract #9525; poster session:

Friday, June 4, 9:00 AM EDT]

-- Tabrecta(R) (capmatinib)*** updated analysis from Phase II GEOMETRY

mono-1 trial

-- Capmatinib in MET exon 14-mutated, advanced NSCLC: Updated results

from the GEOMETRY mono-1 study [Abstract #9020; poster session:

Friday, June 4, 9:00 AM EDT]

-- Lutathera(R) (lutetium Lu 177 dotatate)**** final overall survival data

from Phase III NETTER-1 study in adults with somatostatin

receptor-positive midgut neuroendocrine tumors

-- Final overall survival in the phase 3 NETTER-1 study of

177Lu-DOTATATE in patients with midgut neuroendocrine tumors

[Abstract #4112; poster session: Friday, June 4, 9:00 AM EDT]

Key highlights of data accepted by EHA:

-- Iptacopan (LNP023) efficacy and safety results from Phase

II oral monotherapy trial as first-line treatment in patients with

paroxysmal nocturnal hemoglobinuria

-- First-Line Treatment of PNH Patients With Iptacopan Leads to Rapid

and Durable Hemoglobin Increase by Controlling Both Intra- and

Extra-Vascular Hemolysis [Abstract #S173; oral presentation:

Friday, June 11, 9:00 AM CEST]

-- Subgroup analyses of REACH2 trial evaluating Jakavi(R) (ruxolitinib)*****

in acute graft-versus-host disease

-- Efficacy and Safety of Ruxolitinib in Patients With

Steroid-Refractory Acute Graft-Vs-Host Disease After Crossover in

the Phase 3 REACH2 Study [Abstract #S236; oral presentation:

Friday, June 11, 9:00 AM CEST]

-- Results from X2105 study of sabatolimab (MBG453), a novel immuno-myeloid

therapy targeting TIM-3, in patients with a myelodysplastic syndromes and

acute myeloid leukemia

-- Sabatolimab Plus Hypomethylating Agents (HMAs) in Patients (Pts)

With High-/Very High-risk Myelodysplastic Syndrome (HR/vHR-MDS)

and Acute Myeloid Leukemia (AML): Subgroup Analysis of a Phase 1

Study [Abstract #S168; oral presentation: Friday, June 11, 9:00 AM

CEST]

-- Safety and efficacy results from the Phase II SOAR trial evaluating

Promacta(R)/Revolade(R) (eltrombopag) in patients with severe acquired

aplastic anemia who cannot use ATG

-- An Interventional, Phase 2, Single-Arm Study to Assess the

Efficacy and Safety of Eltrombopag Combined with Cyclosporine as

First-Line Therapy in Adults with Severe Acquired Aplastic Anemia

(SOAR) [Abstract #S172; oral presentation: Friday, June 11, 9:00

AM CEST]

Product Information

Approved indications for products vary by country and not all

indications are available in every country. The product safety and

efficacy profiles have not yet been established outside the approved

indications. Because of the uncertainty of clinical trials, there is no

guarantee that compounds will become commercially available with

additional indications.

For full prescribing information, including approved indications and

important safety information about marketed products, please visit

https://www.novartisoncology.com/news/product-portfolio.

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May 19, 2021 17:00 ET (21:00 GMT)