- 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
40th 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
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
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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
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actual results may vary materially from those set forth in the
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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
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positions globally in each of these areas. In 2016, the Group
achieved net sales of USD 48.5 billion, while R&D throughout
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companies employ approximately 121,000 full-time-equivalent
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countries around the world. For more information, please visit
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* 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
# # #
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