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Novartis presents new data at SABCS across broad range of breast cancer patient populations, combination treatments and lines of therapy

Novartis International AG /
Novartis presents new data at SABCS across broad range of breast cancer patient
populations, combination treatments and lines of therapy
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

* Presentation of results from the Kisqali(®) (ribociclib) MONALEESA-7 Phase
III trial exclusively studying premenopausal women with HR+/HER2- advanced
breast cancer
* New MONALEESA-2 analyses focused on quality of life, biomarkers and
treatment sequencing to be presented

* Data across portfolio and pipeline address potential of biomarkers and
combination treatments in the neoadjuvant and in the advanced first-line and
second-line setting

Basel, November 14, 2017 - Novartis will present data across its breast cancer
portfolio and pipeline in a broad range of patient populations, treatment
combinations and pathways at the upcoming 40(th) annual San Antonio Breast
Cancer Symposium (SABCS), San Antonio, December 5-9.

"Our presentations at SABCS will address some of the most pressing challenges
and questions facing the advanced breast cancer community, including the need to
better understand treatment sequencing and biomarkers," said Bruno Strigini,
CEO, Novartis Oncology. "At Novartis, we seek to advance scientific
understanding of breast cancer with the ultimate goal of improving treatments
and outcomes for those affected by the disease. We are pleased to share the
latest data from our MONALEESA program, which continues to evaluate the
potential of Kisqali treatment in new patient populations."

Results from the Phase III MONALEESA-7 trial in premenopausal women with
hormone-receptor positive, human epidermal growth factor receptor-2 negative
(HR+/HER2-) advanced or metastatic breast cancer will be presented for the first
time in a late-breaker oral presentation.
* First-line ribociclib vs placebo with goserelin and tamoxifen or a non-
steroidal aromatase inhibitor in premenopausal women with hormone receptor-
positive, HER2-negative advanced breast cancer: Results from the randomized
phase III MONALEESA-7 trial [Abstract #S2-05; Wednesday, December 6, 4:15 -
4:30 PM CST]

Additional abstracts from across the breast cancer portfolio include:

Kisqali(®) (ribociclib)*
* First-line ribociclib + letrozole in hormone receptor-positive, HER2-
negative advanced breast cancer: Efficacy by baseline circulating tumor DNA
alterations in MONALEESA-2 [Abstract #PD4-06; Thursday, December 7, 7:00 -
9:00 AM CST]
* Subsequent treatment for postmenopausal women with hormone receptor-
positive, HER2-negative advanced breast cancer who received ribociclib +
letrozole vs placebo + letrozole in the phase III MONALEESA-2 study
[Abstract #P5-21-18; Friday, December 8, 5:00 - 7:00 PM CST]
* Efficacy and safety of ribociclib plus letrozole in US patients enrolled in
the MONALEESA-2 study [Abstract #P5-21-27; Friday, December 8, 5:00 - 7:00
PM CST]
* Quality of life and patient-reported outcomes in US patients enrolled in the
MONALEESA-2 study [Abstract #P1-13-12; Wednesday, December 6, 5:00 - 7:00 PM
CST]
* EarLEE-2: A phase 3 study of ribociclib + endocrine therapy (ET) for
adjuvant treatment of patients with hormone receptor-positive (HR+), human
epidermal growth factor receptor 2-negative (HER2-), intermediate-risk,
early breast cancer (EBC) [Abstract #OT3-05-06; Friday, December 8, 5:00 -
7:00 PM CST]
* Patient-centered initiatives for improving trial participation of diverse
patient populations in the open-label phase 3b CompLEEment-1 study of
ribociclib plus letrozole in the treatment of HR+/HER2- advanced breast
cancer [Abstract #P4-10-07; Friday, December 8, 7:00 - 9:00 AM CST]

Afinitor(®) (everolimus)
* Serum activin A and outcomes in HR+/HER2- metastatic breast cancer patients
treated with everolimus: Results from BOLERO-2 [Abstract #P1-07-09;
Wednesday, December 6, 5:00 - 7:00 PM CST]
* Ribociclib in combination with everolimus and exemestane in men and
postmenopausal women with HR+/HER2- advanced breast cancer following
progression on a CDK4/6 inhibitor: Efficacy and updated safety and
pharmacokinetic results from phase 1 of the TRINITI-1 study [Abstract #PD5-
11; Thursday, December 7, 5:00 - 7:00 PM CST]

Tykerb(®) (lapatinib)**
* Copy number aberration analysis to predict response to neoadjuvant anti-HER2
therapy: results from the NeoALTTO phase III trial [Abstract #S1-04;
Wednesday, December 6, 10:15 - 10:30 AM CST]
* Circulating tumor DNA in HER2 amplified breast cancer: A translational
research substudy of the NeoALTTO phase III trial [Abstract #PD3-03;
Thursday, December 7, 7:00 - 9:00 AM CST]

Alpelisib (BYL719)
* BYLieve: A phase 2 study of alpelisib with fulvestrant or letrozole for
treatment of PIK3CA mutant, hormone receptor-positive (HR+), human epidermal
growth factor receptor 2-negative (HER2-) advanced breast cancer (aBC)
progressing on/after cyclin-dependent kinase (CDK)4/6 inhibitor therapy
[Abstract #OT3-05-02; Friday, December 8, 5:00 - 7:00 PM CST]
* Alpelisib plus letrozole in estrogen receptor-Positive (ER+), human
epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer
(aBC): Safety and preliminary efficacy analysis from a phase 1b trial
[Abstract #P5-21-06; Friday, December 8, 5:00 - 7:00 PM CST]

LSZ102
* Phase I/Ib study of the SERD LSZ102 alone or in combination with ribociclib
in ER+ breast cancer [Abstract #P5-21-04; Friday, December 8, 5:00 - 7:00 PM
CST]

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 prescribing information, including approved indications and important safety
information about marketed products, please visit
https://www.novartis.com/our-work/product-portfolio.

Alpelisib (BYL719), buparlisib (BKM120) and LSZ102 are investigational
compounds. Efficacy and safety have not been established. There is no guarantee
these compounds will become commercially available.

About Novartis in Advanced Breast Cancer
For more than 25 years, Novartis has been at the forefront of driving scientific
advancements for breast cancer patients and improving clinical practice in
collaboration with the global community. With one of the most diverse breast
cancer pipelines and the largest number of breast cancer compounds in
development, Novartis leads the industry in discovery of new therapies and
combinations, especially in HR+ advanced breast cancer, the most common form of
the disease.

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," "expect," "anticipate," "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; our ability to obtain or maintain
proprietary intellectual property protection; the particular prescribing
preferences of physicians and patients; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; general economic and industry conditions, including the
effects of the persistently weak economic and financial environment in many
countries; safety, quality or manufacturing issues, 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 Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
121,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis and @NovartisCancer at
http://twitter.com/novartiscancer
For Novartis multimedia content, please visit www.novartis.com/news/media-
library
For questions about the site or required registration, please contact
media.relations@novartis.com

* Kisqali was developed by the Novartis Institutes for BioMedical Research
(NIBR) under a research collaboration with Astex Pharmaceuticals.

** Marketed as Tykerb(®) in the United States and as Tyverb(®) in Europe

# # #

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

Eric Althoff Rosemarie Yancosek
Novartis Global Media Relations    Novartis Oncology Communications
+41 61 324 7999 (direct) +1 862 778 9043 (direct)
+41 79 593 4202 (mobile) +1 862 505 9021 (mobile)
eric.althoff@novartis.com rosemarie.yancosek@novartis.com


Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

Central   North America

Samir Shah +41 61 324 7944  Richard Pulik    +1 212 830 2448

Pierre-Michel Bringer +41 61 324 1065    Cory Twining +1 212 830 2417

Thomas Hungerbuehler    +41 61 324 8425

Isabella Zinck +41 61 324 7188



Media release (PDF):
http://hugin.info/134323/R/2149493/824938.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Novartis International AG via GlobeNewswire



 
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