Novartis Highlights Key Data in Patients With Hematologic Diseases and Breast Cancer With More Than 140 Abstracts at ASH and SABCS
• Long-term follow-up data from Jakavi® Phase III
trials in patients with the debilitating blood cancer,
myelofibrosis
• Updated Phase III data in patients with Ph+ CML who switched
to Tasigna® after long-term treatment with Glivec® to
achieve a deeper molecular response
• Pipeline updates on multiple targeted compounds across blood
cancers including PKC412, LBH589 and the investigational
immunotherapy CTL019 (CART-19)
• Abstracts at SABCS highlight ongoing commitment to advanced
breast cancer and PI3K/mTOR inhibitor research including
Afinitor®, BYL719 and BKM120
Basel, November 28, 2012 - Novartis will highlight more than 140
presentations on key data from its extensive oncology portfolio at
the leading year-end scientific meetings devoted to hematology and
breast cancer, demonstrating continued innovation in research and
development efforts to advance the care of patients with cancer and
rare diseases.
The American Society of Hematology (ASH) annual meeting in Atlanta,
held December 8-11, will feature significant data across
hematologic diseases including two-year follow-up data from Phase
III trials of Jakavi® (ruxolitinib) in patients treated with
Jakavi for myelofibrosis and data evaluating molecular response
following treatment with Tasigna® (nilotinib) in patients with
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)
compared with Glivec® (imatinib)* therapy. In addition, updated
data on Exjade® (deferasirox) in non-transfusion-dependent
thalassemia (NTDT), as well as new data on the removal of cardiac
iron in Beta-thalassemia major, will be presented.
Several studies of novel pipeline compounds will also be presented,
including additional Phase I/II findings extending proof-of-concept
data for the investigational therapy CTL019 (formerly known as
CART-19)+ in patients with chronic lymphocytic leukemia (CLL) and
relapsed refractory acute lymphoblastic leukemia (ALL)[1].
"For more than a decade, Novartis Oncology has discovered critical
medicines for cancer patients by following the science," said
Hervé Hoppenot, President, Novartis Oncology. "The
presentations at this year's annual meetings show that our research
and development pipeline has never been stronger, and we expect new
breakthroughs that could lead to even more innovative therapies for
patients."
The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held
December 4-8, will showcase studies exploring therapy with the mTOR
inhibitor Afinitor® (everolimus) and the investigational PI3K
inhibitors BYL719 and BKM120 in patients with hormone
receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast
cancer[2].
"Novartis is committed to helping fulfill the large unmet treatment
need for patients with advanced breast cancer, and we are
continuing to investigate the potential benefits and utility of
Afinitor in this population," said Alessandro Riva, Global Head,
Oncology Development & Medical Affairs, Novartis Oncology. "The
company will also showcase promising results from our pipeline of
PI3K/mTOR inhibitors highlighting our commitment to ongoing
exploration of compounds that impact key disease pathways."
Highlights at ASH include:
• Jakavi (ruxolitinib) - Long-term safety, efficacy and
survival findings from COMFORT-II (COntrolled MyeloFibrosis Study
With ORal JAK Inhibitor Treatment), a Phase III study comparing
ruxolitinib with best available therapy for the treatment of
myelofibrosis (ASH abstract #801; December 10, 6:45 PM EST).
Long-term outcome of ruxolitinib treatment in patients with
myelofibrosis: durable reductions in spleen volume, improvements in
quality of life and overall survival advantage in COMFORT-I (ASH
abstract #800; December 10, 6:30 PM EST).
• Tasigna (nilotinib) - Two-year follow-up results from
Evaluating Nilotinib Efficacy and Safety in Clinical Trials -
Complete Molecular Response (ENESTcmr), evaluating sustained deeper
molecular response following a switch to Tasigna in patients with
Ph+ CML in chronic phase who still had evidence of residual disease
after two or more years of Glivec therapy (ASH abstract #694;
December 10, 5:15 PM EST). Long-term landmark data from Evaluating
Nilotinib Efficacy and Safety in Clinical Trials - Newly Diagnosed
Patients (ENESTnd), correlating early molecular response and
outcome of patients with Ph+ CML in chronic phase (ASH abstract
#167; December 9, 5:30 PM EST). Four-year update from ENESTnd
evaluating superiority of Tasigna vs. Glivec in patients with newly
diagnosed Ph+ CML in chronic phase (ASH abstract #1676; December 8,
5:30 PM EST).
• Exjade (deferasirox) - Two-year update to THALASSA, the
first randomized, placebo-controlled study evaluating reduction of
liver iron concentration and serum ferritin in patients with NTDT
syndromes after treatment with deferasirox oral iron chelation
therapy (ASH abstract #3258; December 10, 6:00 PM EST). First data
from CORDELIA, the first head-to-head multicenter, randomized,
open-label trial evaluating deferasirox compared with deferoxamine
for the removal of cardiac iron in patients with Beta-thalassemia
major and iron overload (ASH abstract #2124; December 9, 6:00 PM
EST).
• CTL019 (CART-19) - Outcomes and extended follow-up from a
Phase I/II study in patients with advanced, refractory and
high-risk CLL and relapsed refractory ALL treated with CART-19
cells (ASH abstract #717; December 10, 5:00 PM EST).
• PKC412 (midostaurin) - First presentation from the pivotal
Phase II study of PKC412 in patients with advanced systemic
mastocytosis and mast cell leukemia (ASH abstract #799; December
10, 6:15 PM EST).
• LBH589 (panobinostat) - Updated results from PANORAMA-2
(PANobinostat ORAl in Multiple myelomA) Phase II study of LBH589 in
combination with bortezomib (BTZ) and dexamethasone in patients
with relapsed and BTZ-refractory multiple myeloma (ASH abstract
#1852; December 8, 5:30 PM EST).
Highlights at SABCS include:
• Afinitor (everolimus) - New data from a Phase II clinical
trial evaluating Afinitor (everolimus) in combination with
fulvestrant in postmenopausal women with HR+ advanced breast cancer
who progressed on a previous endocrine therapy (SABCS abstract
#P2-14-05; December 6, 7:00 AM CST) and an additional Phase II
study evaluating the potential efficacy of Afinitor in combination
with letrozole (SABCS abstract #P5-20-06; December 7, 5:00 PM CST).
Final progression-free survival analysis of BOLERO-2 Phase III
trial of Afinitor plus exemestane for postmenopausal women with
HR+/HER2- advanced breast cancer after failure of letrozole or
anastrazole (SABCS abstract #P6-04-02; December 8, 7:00 AM
CST).
• BYL719 - Preliminary results from a Phase I study of BYL719
in patients with PIK3CA mutant ER+ metastatic breast cancer (SABCS
abstract #P6-10-07; December 8, 7:00 AM CST).
• BKM120 - Abstract highlighting trial in progress BELLE-3
Phase III randomized study of PI3K inhibitor BKM120 in combination
with fulvestrant in postmenopausal women with HR+/HER2- advanced
breast cancer whose disease has progressed after treatment with an
aromatase inhibitor and on or after an mTOR inhibitor (SABCS
abstract #OT2-3-08; December 6, 5:00 PM CST).
• LBH589 (panobinostat) - Pre-clinical data explores the
potential utility of HDAC inhibition in triple-negative breast
cancer alone and in combination with other agents (SABCS abstract
#S3-7; December 6, 9:30 AM CST).
About Jakavi (ruxolitinib)
Jakavi (INC424, ruxolitinib) is an oral inhibitor of the JAK 1 and
JAK 2 tyrosine kinases[3] and was approved by the European
Commission in August 2012 for the treatment of disease-related
splenomegaly or symptoms in adult patients with primary
myelofibrosis (also known as chronic idiopathic myelofibrosis),
post-polycythemia vera myelofibrosis or post-essential
thrombocythemia myelofibrosis. Jakavi is available in more than 30
countries including the European Union member states and Canada,
with additional global regulatory filings underway.
Novartis licensed INC424 (ruxolitinib) from Incyte Corporation for
development and commercialization outside the US. Both the European
Commission and the US Food and Drug Administration (FDA) granted
INC424 (ruxolitinib) orphan drug status for myelofibrosis. Jakavi
is marketed in the United States by Incyte Corporation under the
name Jakafi® for the treatment of patients with intermediate or
high-risk myelofibrosis.
Jakavi is a registered trademark of Novartis AG in countries
outside the United States. Jakafi is a registered trademark of
Incyte Corporation.
Jakavi Important Safety Information
Jakavi can cause serious side effects, including a decrease in
blood cell count and infections. Complete blood count monitoring is
recommended. Dose reduction or interruption may be required in
patients with severe hepatic or renal impairment or in patients
developing hematologic adverse reactions such as thrombocytopenia,
anemia and neutropenia. Dose reductions are also recommended when
Jakavi is co-administered with strong CYP3A4 inhibitors or
fluconazole. Use of Jakavi during pregnancy is not recommended and
women should avoid becoming pregnant during Jakavi therapy. Women
taking Jakavi should not breast feed.
The most common adverse drug reactions, occurring at any level of
severity, (incidence >10%) are urinary tract infections, anemia,
thrombocytopenia, neutropenia, hypercholesterolemia, dizziness,
headache, alanine aminotransaminase increased, asparte
aminotransferase increased, bruising, bleeding and increased blood
pressure. Other common adverse drug reactions (incidence 1 to 10%)
are herpes zoster, weight gain, flatulence and tuberculosis
(1%).
Please see full Prescribing Information for Jakavi available at
www.jakavi.com.
About Tasigna (nilotinib)
Tasigna (nilotinib) is approved in more than 90 countries for the
treatment of chronic phase and accelerated phase Philadelphia
chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult
patients resistant or intolerant to at least one prior therapy,
including imatinib, and/or for the treatment of adult patients with
newly diagnosed Ph+ CML in chronic phase. Take twice daily 12 hours
apart. Do not take with food. No food to be consumed for 2 hours
before or one hour after dosing. Avoid grapefruit juice and CYP3A4
inhibitors.
Tasigna Important Safety Information
Use with caution in patients with uncontrolled or significant
cardiac disease and in patients who have or may develop
prolongation of QTc. Low levels of potassium or magnesium must be
corrected prior to Tasigna administration. Monitor closely for an
effect on the QTc interval. Baseline ECG is recommended prior to
initiating therapy and as clinically indicated. Uncommon cases (0.1
to 1%) of sudden death have been reported in clinical studies in
patients with significant risk factors.
Use with caution in patients with liver impairment, with a history
of pancreatitis and with total gastrectomy. Patients with rare
hereditary problems of galactose intolerance, severe lactase
deficiency or glucose-galactose malabsorption should not use
Tasigna. Tasigna may cause fetal harm in pregnant women. Women
taking Tasigna should not breastfeed.
The most frequent Grade 3 or 4 adverse events are hematological
(neutropenia and thrombocytopenia) which are generally reversible
and usually managed by withholding Tasigna temporarily or dose
reduction. Monitor blood counts regularly. Pancreatitis has been
reported. The most frequent non-hematologic adverse events were
rash, pruritus, nausea, fatigue, headache, alopecia, myalgia,
constipation and diarrhea. Most of these adverse events were mild
to moderate in severity.
Please see full Prescribing Information.
About Glivec (imatinib)
Glivec (imatinib) is approved in more than 110 countries for the
treatment of all phases of Ph+ CML, for the treatment of adult
patients with KIT (CD117)-positive gastrointestinal stromal tumors
(GIST) which cannot be surgically removed and/or have metastasized,
and for the treatment of adult patients following complete surgical
removal of KIT+ GIST. Take with food and a large glass of
water.
Glivec Important Safety Information
Glivec can cause fetal harm in pregnant woman. Glivec has been
associated with severe edema (swelling) and serious fluid
retention. Cytopenias (anemia, neutropenia, thrombocytopenia) are
common, generally reversible and usually managed by withholding
Glivec or dose reduction. Monitor blood counts regularly. Severe
congestive heart failure and left ventricle dysfunction, severe
liver problems including cases of fatal liver failure and severe
liver injury requiring liver transplants have been reported. Use
caution in patients with cardiac dysfunction and hepatic
dysfunction. Monitor carefully.
Bleeding may occur. Severe gastrointestinal (GI) bleeding has been
reported in patients with KIT+ GIST. Skin reactions, hypothyroidism
in patients taking levothyroxine replacement, GI perforation, in
some cases fatal and tumor lysis syndrome, which can be life
threatening, have also been reported with Glivec. Correct
dehydration and high uric acid levels prior to treatment. Long-term
use may result in potential liver, kidney, and/or heart toxicities;
immune system suppression may also result from long-term use. In
patients with hypereosinophilic syndrome and heart involvement,
cases of heart disease have been associated with the initiation of
Glivec therapy. Growth retardation has been reported in children
taking Glivec. The long-term effects of extended treatment with
Glivec on growth in children are unknown.
The most common side effects include fluid retention, muscle cramps
or pain and bone pain, abdominal pain, loss of appetite, vomiting,
diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue
and rash.
Please see full Prescribing Information.
About Exjade (deferasirox)
Exjade (deferasirox) is an oral iron chelation therapy indicated
for the treatment of chronic iron overload due to frequent blood
transfusions (>=7 ml/kg/month of packed red blood cells) in
patients with beta thalassemia aged 6 years and older). It is also
indicated for the treatment of chronic iron overload due to blood
transfusions when deferoxamine therapy is contraindicated or
inadequate in the following patient groups: patients with beta
thalassemia major with iron overload due to frequent blood
transfusions (>=7 ml/kg/month of packed red blood cells) aged 2
to 5 years; patients with beta thalassemia major with iron overload
due to infrequent blood transfusions (<7 ml/kg/month of packed
red blood cells) aged 2 years and older; and patients with other
anemias aged 2 years and older[4].
It is approved in more than 100 countries including the US,
Switzerland, Japan and countries comprising the EU. The approved
indication may vary depending upon the individual country.
Exjade Important Safety Information
Exjade is contraindicated in patients with an estimated creatinine
clearance <60 mL/min, with hypersensitivity to the active
substance or any of the excipients, or in combination with other
iron chelator therapies. Exjade is not recommended in patients with
severe hepatic impairment.
There have been postmarketing reports of acute renal failure,
hepatic failure and cytopenias. Renal failure requiring temporary
or permanent dialysis, renal tubulopathy and interstitial nephritis
have been reported. Upper gastrointestinal ulceration and
hemorrhage, sometimes fatal, have been reported. Caution should be
used in elderly patients due to a higher frequency of adverse
reactions. Exjade is not recommended in patients with a short life
expectancy (e.g., high-risk myelodysplastic syndromes), especially
when co-morbidities could increase the risk of adverse
events.
Skin rashes, serious hypersensitivity reactions, decreased hearing
and lens opacities have been reported. The most common adverse
reactions are nausea, vomiting, diarrhea, abdominal pain, rash,
non-progressive increases in serum creatinine, increased
transaminases, abdominal distension, constipation, dyspepsia,
proteinuria and headache.
Please visit www.exjade.com for more information.
About Afinitor (everolimus)
Afinitor (everolimus) is approved in the European Union for the
treatment of hormone receptor-positive (HR+)/HER2-negative (HER2-)
advanced breast cancer, in combination with exemestane, in
postmenopausal women without symptomatic visceral disease after
recurrence or progression following a non-steroidal aromatase
inhibitor. In the United States, Afinitor is approved for the
treatment of postmenopausal women with advanced hormone
receptor-positive, HER2-negative breast cancer in combination with
exemestane after failure of treatment with letrozole or
anastrozole.
Afinitor (everolimus) tablets is approved in more than 80 countries
including the United States and throughout the European Union in
the oncology settings of advanced renal cell carcinoma following
progression on or after vascular endothelial growth factor
(VEGF)-targeted therapy, and in the United States and European
Union for locally advanced, metastatic or unresectable progressive
neuroendocrine tumors of pancreatic origin.
Everolimus is also approved as Votubia® (everolimus) tablets in
the European Union for the treatment of adult patients with renal
angiomyolipoma associated with tuberous sclerosis complex (TSC) who
are at risk of complications (based on factors such as tumor size
or presence of aneurysm, or presence of multiple or bilateral
tumors) but who do not require immediate surgery. The evidence is
based on analysis of change in sum of angiomyolipoma volume.
Votubia is also approved in the EU for the treatment of patients
aged 3 years and older with subependymal giant cell astrocytoma
(SEGA) associated with TSC, who require therapeutic intervention
but are not amenable to surgery. The evidence is based on analysis
of change in SEGA volume. Further clinical benefit, such as
improvement in disease-related symptoms, has not been
demonstrated.
Everolimus is also available from Novartis for use in non-oncology
patient populations under the brand names Certican® and
Zortress® and is exclusively licensed to Abbott and sublicensed
to Boston Scientific for use in drug-eluting stents.
Indications vary by country and not all indications are available
in every country. The safety and efficacy profile of everolimus has
not yet been established outside the approved indications. Because
of the uncertainty of clinical trials, there is no guarantee that
everolimus will become commercially available for additional
indications anywhere else in the world.
Afinitor Important Safety Information
Afinitor/Votubia can cause serious side effects including lung or
breathing problems, infections and renal failure, which can lead to
death. Mouth ulcers and mouth sores are common side effects.
Afinitor/Votubia can affect blood cell counts, kidney and liver
function, and blood sugar and cholesterol levels. Afinitor/Votubia
may cause fetal harm in pregnant women. Highly effective
contraception is recommended for women of child-bearing potential
while receiving Afinitor/Votubia and for up to eight weeks after
ending treatment. Women taking Afinitor/Votubia should not breast
feed.
The most common adverse drug reactions (incidence >=15%) are
mouth ulcers, diarrhea, feeling weak or tired, skin problems (such
as rash or acne), infections, nausea, swelling of extremities or
other parts of the body, loss of appetite, headache, inflammation
of lung tissue, abnormal taste, nose bleeds, inflammation of the
lining of the digestive system, weight decreased and vomiting. The
most common grade 3-4 adverse drug reactions (incidence >=2%)
are mouth ulcers, feeling tired, low white blood cells (a type of
blood cell that fights infection), diarrhea, infections,
inflammation of lung tissue, diabetes and amenorrhea. Cases of
hepatitis B reactivation and blood clots in the lung and leg have
been reported.
Please see full Prescribing Information.
About CTL019, PKC412, LBH589, BYL719 and BKM120
Because these are investigational compounds, the safety and
efficacy profile of CTL019, PKC412, LBH589, BYL719 and BKM120 have
not yet been established. Access to these investigational compounds
is available only through carefully controlled and monitored
clinical trials. These trials are designed to better understand the
potential benefits and risks of the compound. Because of
uncertainty of clinical trials, there is no guarantee that CTL019,
PKC412, LBH589, BYL719 and BKM120 will ever be commercially
available anywhere in the world.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as "pipeline," "ongoing,"
"commitment," "will," "expects," "could," "committed," "potential,"
"exploration," "explores," or similar expressions, or by express or
implied discussions regarding potential marketing submissions or
approvals for investigational compounds, or potential new
indications or labeling for existing products, or regarding
potential future revenues from such products. You should not place
undue reliance on these statements. Such forward-looking statements
reflect the current views of management regarding future events,
and involve known and unknown risks, uncertainties and other
factors that may cause actual results to be materially different
from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that any of
the investigational compounds referred to in this release will be
submitted or approved for sale in any market, or at any particular
time. Nor can there be any guarantee that any of the approved
products referred to in this release will be submitted or approved
for any additional indications or labeling in any market, or at any
particular time. Neither can there be any guarantee that any of the
investigational compounds or products referred to in this release
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding such products could
be affected by, among other things, unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; unexpected
regulatory actions or delays or government regulation generally;
competition in general; government, industry and general public
pricing pressures; the company's ability to obtain or maintain
patent or other proprietary intellectual property protection;
unexpected manufacturing issues; the impact that the foregoing
factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in Novartis
AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those anticipated,
believed, estimated or expected. 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, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools,
over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2011, the
Group achieved net sales of USD 58.6 billion, while approximately
USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group.
Novartis Group companies employ approximately 127,000
full-time-equivalent associates and operate in more than 140
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.
* Known as Gleevec® (imatinib mesylate) tablets in the US,
Canada and Israel.
+ CTL019 is developed in collaboration with the University of
Pennsylvania.
References
1. American Society of Hematology. ASH Annual 2012 Meeting Program.
Available at https://ash.confex.com/ash/2012/webprogram/start.html.
Accessed November 2012.
2. San Antonio Breast Cancer Symposium. SABCS Annual 2012 Meeting
Program. Available at
http://www.sabcs.org/ProgramSchedule/index.asp. Accessed November
2012.
3. JAKAVI [Summary of Product Characteristics]. Basel, Switzerland:
Novartis Pharma AG; 2012.
4. EMC. Summary of product characteristics: EXJADE 125 mg, 250mg,
500mg dispersible tablets. Last updated January 13, 2012. Accessed
at http://www.medicines.org.uk/emc/medicine/18805.
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Posted: November 2012
