Press Release: Novartis showcases significant data updates from Kisqali(R), iptacopan and Scemblix(R) at SABCS and ASH

-- Late-breaking final iDFS analysis from NATALEE investigating Kisqali(R)

(ribociclib) in broad population of patients with stage II and III

HR+/HER2- early breast cancer, including those with node-negative disease

-- New 48-week efficacy and safety data from the Phase III APPLY-PNH trial

of investigational oral monotherapy iptacopan in anti-C5-treated adult

patients with paroxysmal nocturnal hemoglobinuria (PNH) and persistent

anemia

-- Nearly 4 year follow-up efficacy and safety results from end of study

treatment update of ASCEMBL with Scemblix(R) (asciminib) in patients with

Ph+ chronic phase-chronic myeloid leukemia (CP-CML) after >=2 Prior

Tyrosine Kinase Inhibitors

Basel, November 20, 2023 -- Novartis will present data from over 100 trials across its breast cancer and hematology portfolios at the 2023 San Antonio Breast Cancer Symposium (SABCS) and the American Society of Hematology (ASH) Annual Meeting & Exposition. The new data will highlight the latest advances across our breast cancer and hematology portfolios and pipeline, such as the Phase III NATALEE trial and Phase III APPLY-PNH trial.

"We're developing new therapies across a range of cancers and blood disorders as well as evaluating the potential of our priority medicines in earlier stages of disease," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "Among the new findings we will present at SABCS and ASH this year are additional follow-up Kisqali data from NATALEE, adding to the body of evidence of ribociclib in early breast cancer, as well as new 48-week data from the Phase III APPLY-PNH trial for iptacopan."

Key highlights of data accepted by SABCS include:

Medicine Abstract Title Abstract Number/

Presentation Details

------------------------ ------------------------------------------------------------------ ----------------------

Kisqali(R) (ribociclib)* Ribociclib (RIB) + nonsteroidal aromatase inhibitor Abstract #GS03-03

(NSAI) as adjuvant treatment in patients with HR+/HER2- Oral Presentation

early breast cancer: final invasive disease--free Friday, December 8

survival (iDFS) analysis from the NATALEE trial 8:15 -- 11:15 AM CT

------------------------ ------------------------------------------------------------------ ----------------------

Kisqali(R) (ribociclib)* Invasive disease-free survival as a surrogate for Abstract #PO1-17-07

overall survival in patients with hormone receptor-positive/human Poster Session

epidermal growth factor receptor 2-negative early Wednesday, December 6

breast cancer: a real-world analysis 12:00 -- 2:00 PM CT

------------------------ ------------------------------------------------------------------ ----------------------

Kisqali(R) (ribociclib)* Patient preferences for CDK4/6 inhibitor treatments Abstract #PO2-01-09

in HR+/HER2- early breast cancer: a discrete choice Poster Session

survey study Wednesday, December 6

5:00 -- 7:00 PM CT

------------------------ ------------------------------------------------------------------ ----------------------

Key highlights of data accepted by ASH include:

Medicine or Disease Abstract Title Abstract Number/

State Presentation Details

------------------- ---------------------------------------------------------------- ---------------------------

Iptacopan (LNP023) Factor B Inhibition with Oral Iptacopan Monotherapy Abstract #571

Demonstrates Sustained Long-Term Efficacy and Safety Oral Presentation

in Anti-C5-Treated Patients (pts) with Paroxysmal Sunday, December 10

Nocturnal Hemoglobinuria (PNH) and Persistent Anemia: 4:30 PM PT

Final 48-Week Results from the Multicenter, Phase

III APPLY-PNH Trial

------------------- ---------------------------------------------------------------- ---------------------------

Iptacopan (LNP023) Patient-Reported Improvements in Fatigue and Health-Related Abstract #487

Quality of Life in the Phase 3 Studies APPLY-PNH and Oral Presentation

APPOINT-PNH Evaluating the Use of Iptacopan in C5 Sunday, December 10

Inhibitor-Treated and Treatment-Naïve Patients 9:30 AM PT

with Paroxysmal Nocturnal Hemoglobinuria

------------------- ---------------------------------------------------------------- ---------------------------

Iptacopan (LNP023) Categorization of Hematological Responses to Oral Abstract #4084

Iptacopan Monotherapy in Anti-C5-Treated Patients Poster Presentation

with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Monday, December 11

Persistent Anemia in the Phase III APPLY-PNH Trial 6:00 -- 8:00 PM PT

and Complement Inhibitor-Naïve Patients in the

Phase III APPOINT-PNH Trial

------------------- ---------------------------------------------------------------- ---------------------------

Iptacopan (LNP023) Clinical Breakthrough Hemolysis (BTH) during Monotherapy Abstract #1338

with the Oral Factor B Inhibitor Iptacopan Is Generally Poster Presentation

Not Severe and Managed without Treatment Discontinuation: Saturday, December 9

48-Week Data from the Phase III APPLY-PNH and APPOINT-PNH 5:30 -- 7:30 PM PT

Trials in Paroxysmal Nocturnal Hemoglobinuria (PNH)

------------------- ---------------------------------------------------------------- ---------------------------

Scemblix(R) Sustained Efficacy and Safety with Asciminib (ASC) Abstract #4536

(asciminib) after Almost 4 Years of Median Follow-up from ASCEMBL, Poster Presentation

a Phase 3 Study of ASC vs Bosutinib (BOS) in Patients Monday, December 11

(Pts) with Chronic Myeloid Leukemia in Chronic Phase 6:00 -- 8:00 PM PT

(CML-CP) after >=2 Prior Tyrosine Kinase Inhibitors

(TKIs): An End of Study Treatment (EOS Tx) Update,

Including Results from Switch Population

------------------- ---------------------------------------------------------------- ---------------------------

Scemblix(R) With up to 8 Years of Therapy, Asciminib (ASC) Monotherapy Abstract #450

(asciminib) Demonstrated Continued Favorable Efficacy, Safety, Oral Presentation

and Tolerability in Patients (Pts) with Philadelphia Sunday, December 10

Chromosome--Positive Chronic Myeloid Leukemia in Chronic 10:45 AM PT

Phase (Ph+ CML-CP) without the T315I Mutation: Final

Results from the Phase 1 X2101 Study

------------------- ---------------------------------------------------------------- ---------------------------

Sickle Cell Disease Targeted Degradation of the Wiz Transcription Factor Abstract #2

for Gamma Globin De-Repression Plenary Scientific Session

Sunday, December 10

2:00 -- 4:00 PM PT

------------------- ---------------------------------------------------------------- ---------------------------

Kymriah(R) Clinical Outcomes of Patients with Relapsed/Refractory Abstract #601

(tisagenlecleucel) Follicular Lymphoma Treated with Tisagenlecleucel: Oral Presentation

Phase 2 Elara 3-Year Follow-up Sunday, December 10

4:30 PM PT

------------------- ---------------------------------------------------------------- ---------------------------

Jakavi(R) Ruxolitinib in Patients With Chronic Graft-Versus-Host Abstract #654

(ruxolitinib) Disease: 3-Year Final Analysis of Efficacy and Safety Oral Presentation

From the Phase III REACH3 study Sunday, December 10

5:45 PM PT

------------------- ---------------------------------------------------------------- ---------------------------

Immune The lack of tolerable treatment options that can induce Abstract #1212

Thrombocytopenia durable responses without fear of relapse after discontinuation Poster Presentation

(ITP) represents a significant unmet need for patients (pts) Saturday, December 9

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November 20, 2023 01:15 ET (06:15 GMT)