Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH
20 November 2023 - 5:15PM
- Late-breaking final iDFS analysis from NATALEE investigating
Kisqali® (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® (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® (ribociclib)* |
Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as
adjuvant treatment in patients with HR+/HER2− early breast cancer:
final invasive disease–free survival (iDFS) analysis from the
NATALEE trial |
Abstract #GS03-03 Oral Presentation Friday, December
8 8:15 – 11:15 AM CT |
Kisqali® (ribociclib)* |
Invasive disease-free survival as a surrogate for overall survival
in patients with hormone receptor−positive/human epidermal growth
factor receptor 2−negative early breast cancer: a real-world
analysis |
Abstract #PO1-17-07Poster SessionWednesday, December 612:00 – 2:00
PM CT |
Kisqali® (ribociclib)* |
Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2−
early breast cancer: a discrete choice survey study
|
Abstract #PO2-01-09Poster SessionWednesday, December 65:00 – 7:00
PM CT |
Key
highlights of data accepted by ASH
include:
Medicine or Disease
State |
Abstract Title |
Abstract Number/ Presentation
Details |
Iptacopan (LNP023) |
Factor B Inhibition with Oral Iptacopan Monotherapy Demonstrates
Sustained Long-Term Efficacy and Safety in Anti-C5-Treated Patients
(pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent
Anemia: Final 48-Week Results from the Multicenter, Phase III
APPLY-PNH Trial |
Abstract #571 Oral Presentation Sunday, December
10 4:30 PM PT |
Iptacopan (LNP023) |
Patient-Reported Improvements in Fatigue and Health-Related Quality
of Life in the Phase 3 Studies APPLY-PNH and APPOINT-PNH Evaluating
the Use of Iptacopan in C5 Inhibitor-Treated and Treatment-Naïve
Patients with Paroxysmal Nocturnal Hemoglobinuria |
Abstract #487 Oral Presentation Sunday, December
10 9:30 AM PT |
Iptacopan (LNP023) |
Categorization of Hematological Responses to Oral Iptacopan
Monotherapy in Anti-C5-Treated Patients with Paroxysmal Nocturnal
Hemoglobinuria (PNH) and Persistent Anemia in the Phase III
APPLY-PNH Trial and Complement Inhibitor-Naïve Patients in the
Phase III APPOINT-PNH Trial |
Abstract #4084 Poster Presentation Monday, December
11 6:00 – 8:00 PM PT |
Iptacopan (LNP023) |
Clinical Breakthrough Hemolysis (BTH) during Monotherapy with the
Oral Factor B Inhibitor Iptacopan Is Generally Not Severe and
Managed without Treatment Discontinuation: 48-Week Data from the
Phase III APPLY-PNH and APPOINT-PNH Trials in Paroxysmal Nocturnal
Hemoglobinuria (PNH) |
Abstract #1338 Poster Presentation Saturday, December
9 5:30 – 7:30 PM PT |
Scemblix® (asciminib) |
Sustained Efficacy and Safety with Asciminib (ASC) after Almost 4
Years of Median Follow-up from ASCEMBL, a Phase 3 Study of ASC vs
Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in
Chronic Phase (CML-CP) after ≥2 Prior Tyrosine Kinase Inhibitors
(TKIs): An End of Study Treatment (EOS Tx) Update, Including
Results from Switch Population |
Abstract #4536 Poster Presentation Monday, December
11 6:00 – 8:00 PM PT |
Scemblix® (asciminib) |
With up to 8 Years of Therapy, Asciminib (ASC) Monotherapy
Demonstrated Continued Favorable Efficacy, Safety, and Tolerability
in Patients (Pts) with Philadelphia Chromosome–Positive Chronic
Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) without the T315I
Mutation: Final Results from the Phase 1 X2101 Study |
Abstract #450 Oral Presentation Sunday, December
10 10:45 AM PT |
Sickle Cell Disease |
Targeted Degradation of the Wiz Transcription Factor for Gamma
Globin De-Repression |
Abstract #2 Plenary Scientific Session Sunday, December
10 2:00 – 4:00 PM PT |
Kymriah® (tisagenlecleucel) |
Clinical Outcomes of Patients with Relapsed/Refractory Follicular
Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year
Follow-up |
Abstract #601 Oral Presentation Sunday, December
10 4:30 PM PT |
Jakavi® (ruxolitinib) |
Ruxolitinib in Patients With Chronic Graft-Versus-Host Disease:
3-Year Final Analysis of Efficacy and Safety From the Phase III
REACH3 study |
Abstract #654 Oral Presentation Sunday, December
10 5:45 PM PT |
Immune Thrombocytopenia (ITP) |
The lack of tolerable treatment options that can induce durable
responses without fear of relapse after discontinuation represents
a significant unmet need for patients (pts) with immune
thrombocytopenia (ITP): Results from the ITP world impact survey
(I-WISh) 2.0 |
Abstract #1212 Poster Presentation Saturday, December
9 5:30 – 7:30 PM PT |
Product Information For full
prescribing information, including approved indications and
important safety information about marketed products, please visit
https://www.novartis.com/about/products.
DisclaimerThis 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,” “seek,” “look forward,” “believe,”
“committed,” “investigational,” “pipeline,” “launch,” or similar
terms, or by express or implied discussions regarding potential
marketing approvals, new indications or labeling for the
investigational or approved products described in this press
release, or regarding potential future revenues from such products.
You should not place undue reliance on these statements. Such
forward-looking statements are based on our current beliefs and
expectations 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 regarding such products
could be affected by, among other things, the uncertainties
inherent in research and development, including clinical trial
results and additional analysis of existing clinical data;
regulatory actions or delays or government regulation generally;
global trends toward health care cost containment, including
government, payor and general public pricing and reimbursement
pressures and requirements for increased pricing transparency; our
ability to obtain or maintain proprietary intellectual property
protection; the particular prescribing preferences of physicians
and patients; general political, economic and business conditions,
including the effects of and efforts to mitigate pandemic diseases;
safety, quality, data integrity or manufacturing issues; potential
or actual data security and data privacy breaches, or disruptions
of our information technology systems, and other risks and factors
referred to in Novartis AG’s current Form 20-F on file with 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
contained in this press release as a result of new information,
future events or otherwise.
About NovartisNovartis is an
innovative medicines company. Every day, we work to reimagine
medicine to improve and extend people’s lives so that patients,
healthcare professionals and societies are empowered in the face of
serious disease. Our medicines reach more than 250 million people
worldwide.
Reimagine medicine with us: Visit us at https://www.novartis.com
and connect with us on LinkedIn, Facebook, X/Twitter and
Instagram.
# # #
* Kisqali was developed by the Novartis Institutes for
BioMedical Research (NIBR) under a research collaboration with
Astex Pharmaceuticals.
Novartis
Media RelationsE-mail: media.relations@novartis.com
|
|
|
Central |
|
North America |
|
Richard Jarvis |
+41 79 584 2326 |
Julie Masow |
+1 862 579 8456 |
Anja von TreskowAnna
Schäfers |
+41 79 392 9697+41 79
801 7267 |
Michael MeoMarlena Abdinoor |
+1 862 274 5414+1 617
335 9525 |
SwitzerlandSatoshi
Sugimoto |
+41
79 619 2035 |
|
|
|
|
|
|
Novartis
Investor RelationsCentral investor relations line: +41 61
324 7944E-mail: investor.relations@novartis.com |
|
|
|
|
|
|
Central |
|
North America |
|
Samir Shah |
+41 61 324 7944 |
Sloan Simpson |
+1 862 345 4440 |
Nicole Zinsli-Somm |
+41 61 324 3809 |
Parag Mahanti |
+1 973 876 4912 |
Isabella Zinck |
+41 61 324 7188 |
Jonathan Graham |
+1 201 602 9921 |
Imke Kappes |
+41 61 324 82 69 |
|
|
Zain Iqbal |
+41 61 324 03 90 |
|
|
Novan (NASDAQ:NOVN)
Historical Stock Chart
From Nov 2024 to Dec 2024
Novan (NASDAQ:NOVN)
Historical Stock Chart
From Dec 2023 to Dec 2024