EAST HANOVER, N.J.,
Nov. 2, 2018 /PRNewswire/
-- Novartis will present new research that may transform the
way serious blood diseases and a certain type of breast cancer are
treated at the upcoming 60th American Society of
Hematology (ASH) Annual Meeting & Exposition in San Diego, December
1-4 and the 41st Annual San Antonio Breast Cancer
Symposium (SABCS), December 4-8.
Nearly 150 abstracts will be presented across both congresses,
underscoring the strength of the Novartis pipeline and portfolio in
hematology and oncology.
"Novartis Oncology has a purpose-driven legacy built on an
unwavering commitment to help patients live better and longer
lives," said Liz Barrett, CEO,
Novartis Oncology. "The breadth and
depth of our data at these scientific forums demonstrates how we
are acting on our vision to reimagine cancer in a meaningful way
for patients by relentlessly pursuing scientific advancements and
exploring novel combination treatment options to help those living
with hard-to-treat diseases."
Novartis data at the 2018 ASH Annual Meeting will highlight
the following:
Updates on outcomes with Kymriah®
(tisagenlecleucel) in adult relapsed or refractory (r/r) patients
with diffuse large b-cell lymphoma (DLBCL) and pediatric and young
adult patients with r/r acute lymphoblastic leukemia
(ALL)*:
- Updated analysis of the efficacy and safety of tisagenlecleucel
in pediatric and young adult patients with relapsed/refractory
acute lymphoblastic leukemia [Abstract #895; Monday, December 3, 4:30
PM PT]
- Sustained disease control for adult patients with relapsed or
refractory diffuse large b-cell lymphoma: an updated analysis of
JULIET, a global pivotal Phase 2 trial of tisagenlecleucel
[Abstract #1684; Saturday, December
1, 6:15 PM PT]
New post-hoc analysis of the SUSTAIN study evaluating
crizanlizumab in patients with sickle cell disease:
- Established prevention of vaso-occlusive crises with
crizanlizumab is further improved in patients who follow the
standard treatment regimen: post-hoc analysis of the Phase II
SUSTAIN study [Abstract #1082; Saturday,
December 1, 6:15 PM PT]
First reported data for investigational compound asciminib
(ABL001) in chronic myeloid leukemia (CML) patients with T315I
genetic mutation that causes resistance to most BCR-ABL tyrosine
kinase inhibitors (TKIs) approved to treat CML:
- Asciminib (ABL001), a specific allosteric BCR-ABL1 inhibitor,
in patients with chronic myeloid leukemia and the T315I mutation in
a Phase 1 trial [Abstract #792; Monday,
December 3, 4:00 PM PT]
New data evaluating dabrafenib and trametinib combination
treatment in hairy cell leukemia (HCL):
- Treatment with combination of dabrafenib and trametinib in
patients with recurrent/refractory BRAF V600E–mutated hairy
cell leukemia (HCL) [Abstract #391; Sunday,
December 2, 12:00 PM PT]
Data evaluating Promacta® (eltrombopag) in
patients with immune thrombocytopenia (ITP):
- Bleeding related episodes, thrombotic events and platelet
counts among immune thrombocytopenia patients receiving second line
therapy [Abstract #2436; Sunday, December
2, 6:00 PM PT]
- Treatment of ITP with eltrombopag in patients who have received
prior rituximab: a post hoc analysis of the EXTEND study [Abstract
#1152; Saturday, December 1,
6:15 PM PT]
Final results from the ITP World Impact Survey (I-WISh)
about the burden of disease and impact of ITP on patient quality of
life and productivity:
- Patients with immune thrombocytopenia (ITP) frequently
experience severe fatigue but it is under-reported by physicians:
Results from the ITP World Impact Survey (I-WISh) [Abstract #2273;
Saturday, December 1, 6:15 PM PT]
- Patients with immune thrombocytopenia (ITP) experience impaired
quality of life (QoL), with negative effects on their daily
activities, social interactions, emotional well-being and working
lives: Results from the ITP World Impact Survey (I-WISh) [Abstract
#4804; Monday, December 3,
6:00 PM PT]
New analyses evaluating Rydapt® (midostaurin)
in patients with FLT3-mutated acute myeloid leukemia
(AML):
- Prognostic impact of insertion site in acute myeloid leukemia
with FLT3 internal tandem duplication: results from the RATIFY
study [Abstract #435; Sunday, December
2, 5:00 PM PT]
- RATIFY: prognostic impact of FLT3 tyrosine kinase domain (TKD)
and NPM1 mutation status in patients with newly diagnosed acute
myeloid leukemia (AML) treated with midostaurin or placebo plus
standard chemotherapy [Abstract #2668; Sunday, December 2, 6:00
PM PT]
- RADIUS: A phase 2 randomized trial investigating standard of
care ± midostaurin after allogeneic stem cell transplant in
FLT3-ITD–mutated AML [Abstract #662; Monday,
December 3, 10:45 AM PT]
New data evaluating
Jadenu® (deferasirox) in
patients with low- and int-1-risk myelodysplastic syndromes (MDS)
and chronic iron overload:
- Safety and efficacy, including event-free survival, of
deferasirox versus placebo in iron-overloaded patients with low-
and int-1-risk myelodysplastic syndromes (MDS): outcomes from the
randomized, double-blind TELESTO study [Abstract #234; Saturday, December 1, 5:15
PM PT]
New data evaluating Jakavi® (ruxolitinib)** for
patients with polycythemia vera who are resistant to or intolerant
of hydroxyurea:
- Long-term efficacy and safety (5 Years) in RESPONSE, a Phase 3
study comparing ruxolitinib (rux) with best available therapy (BAT)
in hydroxyurea (HU)-resistant/intolerant patients (pts) with
polycythemia vera (PV) [Abstract #1753; Saturday, December 1, 6:15
PM PT]
Additional data presented at ASH include:
- Complete responses in relapsed/refractory acute myeloid
leukemia (AML) patients on a weekly dosing schedule of XmAb14045, a
CD123 x CD3 T cell-engaging bispecific antibody: initial results of
a phase 1 study [Abstract #763; Monday,
December 3, 2:45 PM PT]
Sandoz, a Novartis division and the pioneer and global
leader in biosimilars will present data for the company's
pegfilgrastim, filgrastim and rituximab biosimilars:
- Cost simulation for the US of febrile neutropenia
hospitalization due to pegfilgrastim on-body injector failure
compared to single-injection pegfilgrastim and daily injections
with reference and biosimilar filgrastim in non-Hodgkin lymphoma
[Abstract #2251; Saturday, December
1, 6:15 PM PT]
- Subcutaneous versus intravenous rituximab in non-Hodgkin
lymphoma treated with R-CHOP: economic modeling for the US
[Abstract #4776; Monday, December 3,
6:00 PM PT]
Novartis data at the 2018 SABCS Annual Symposium will
highlight the following:
New data evaluating
Kisqali® (ribociclib)*** in broad range of patients
with hormone receptor positive, human epidermal growth factor
receptor-2 negative (HR+/HER2–) advanced breast
cancer:
- Biomarker analysis by baseline circulating tumor DNA
alterations in the MONALEESA-3 study [Abstract #PD2-05;
Wednesday, December 5, 5:00 PM CT]
- Ribociclib + endocrine therapy in patients with hormone
receptor-positive, HER2-negative advanced breast cancer presenting
with visceral metastases: Subgroup analysis of phase III MONALEESA
trials [Abstract #P6-18-07; Saturday,
December 8, 7:00 AM CT]
- Ribociclib with endocrine therapy for premenopausal patients
with hormone receptor-positive, HER2-negative advanced breast
cancer: Biomarker analyses from the phase III randomized
MONALEESA-7 trial [Abstract #PD2-08; Wednesday, December 5, 5:00 PM CT]
- Ribociclib treatment benefit in patients with advanced breast
cancer with ≥1 dose reduction: Data from the MONALEESA-2, -3, and
-7 trials [Abstract #P6-18-06; Saturday,
December 8, 7:00 AM CT]
Additional updates on investigational treatments, BYL719
(alpelisib) and LSZ102:
- Alpelisib + fulvestrant for advanced breast cancer: Subgroup
analyses from the Phase III SOLAR-1 trial [Abstract #GS3-08;
Thursday, December 6, 11:15 AM CT]
- Phase 1/1b study of novel oral
selective estrogen receptor degrader (SERD) LSZ102 for estrogen
receptor-positive (ER+) advanced breast cancer (ABC) with
progression on endocrine therapy (ET) [Abstract #PD1-08;
Wednesday, December 5, 5:00 PM CT]
Sandoz will present US real-world evidence data surrounding
cost-effectiveness through use of the company's biosimilar
filgrastim-sndz:
- Potential Medicare beneficiary out-of-pocket cost reductions
through use of biosimilar filgrastim-sndz over reference filgrastim
among breast cancer patients: a simulation model analysis [Abstract
#675; Friday, December 7,
5:00 PM CT]
Throughout the 2018 ASH Annual Meeting and SABCS Annual
Symposium, Novartis will host dedicated content on
https://www.novartis.com/our-focus/cancer that will feature unique
insights and perspectives on emerging areas of cancer care and
research.
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.novartis.com/our-company/global-product-portfolio.
Asciminib (ABL001), crizanlizumab (SEG101), alpelisib (BYL719)
and LSZ102 are investigational compounds. Efficacy and safety have
not been established. There is no guarantee these compounds will
become commercially available.
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;
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and factors referred to in Novartis AG's current Form 20-F on file
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About Novartis
Novartis is reimagining medicine
to improve and extend people's lives. As a leading global medicines
company, we use innovative science and digital technologies to
create transformative treatments in areas of great medical need. In
our quest to find new medicines, we consistently rank among the
world's top companies investing in research and development.
Novartis products reach nearly 1 billion people globally and we are
finding innovative ways to expand access to our latest treatments.
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*Novartis and the University of
Pennsylvania's Perelman School of Medicine (Penn) have a global collaboration to research,
develop and commercialize chimeric antigen receptor T cell (CAR-T)
therapies for the investigational treatment of cancers.
**Jakavi is a registered trademark of Novartis AG in countries
outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Novartis licensed
ruxolitinib from Incyte Corporation for development and
commercialization outside the United
States.
***Kisqali was developed by the Novartis Institutes for
BioMedical Research (NIBR) under a research collaboration with
Astex Pharmaceuticals.
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SOURCE Novartis Pharmaceuticals Corporation