Novartis highlights advances for patients with breast cancer and hematological diseases with over 160 SABCS and ASH abstracts
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Novartis highlights advances for patients with breast cancer and hematological
diseases with over 160 SABCS and ASH abstracts
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* Updated Phase III data from BOLERO-2 trial studying everolimus in women with
ER+HER2- advanced breast cancer
* Tasigna(®) Phase III trials in Ph+ CML including 36-month follow-up data in
newly diagnosed patients
* Exjade(®) pivotal study results investigating iron chelation in patients
with non-transfusion-dependent thalassemia
* Phase III trial further exploring benefit of INC424 (ruxolitinib) in
patients with myelofibrosis, a debilitating blood cancer with limited
treatment options
Basel, December 2, 2011 - Novartis will showcase more than one hundred and sixty
presentations on data from its robust oncology portfolio at two key medical
congresses this month, demonstrating significant advances for patients with
cancers and hematological diseases.
The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held from December
6-10, will feature data presentations from Phase III studies of Afinitor(®)
(everolimus) tablets for investigational uses and Zometa(®) (zoledronic acid)
4mg/5mL Injection, as well as early-stage studies of the investigational drug
BKM120, an inhibitor of PI3K, a key cancer pathway[1].
The American Society of Hematology (ASH) annual meeting in San Diego, held from
December 10-13, will showcase key data for Tasigna(®) (nilotinib), Exjade(®)
(deferasirox) and the investigational drug INC424 (ruxolitinib)(1). Several
early-stage studies will also be presented, including everolimus in Hodgkin
lymphoma and Waldenström's macroglobulinemia and LBH589 (panobinostat) in
relapsed and bortezomib (BTZ)-refractory multiple myeloma[2].
"These important data are examples of our research and development strategy to
focus on significant unmet medical needs by targeting the fundamental mechanisms
of disease," said Hervé Hoppenot, President, Novartis Oncology. "Through our
collaborations with the scientific and patient communities, we continue to
advance our goal of transforming patients' lives."
Highlights at SABCS include:
* Everolimus - Updated data from the BOLERO-2 (Breast cancer trials of OraL
EveROlimus) Phase III trial of everolimus in combination with exemestane for
postmenopausal women with ER+HER2- advanced breast cancer who recurred or
progressed while on or following previous treatment with the hormonal
therapies letrozole or anastrozole (SABCS abstract #S3-7; December 8, 9:30 -
11:15AM).
* Zometa - ABCSG-12 (Austrian Breast & Colorectal Cancer Study Group Trial)
long-term data will examine possible carry-over anticancer benefits of
zoledronic acid three years after treatment completion in premenopausal
women with endocrine-responsive early breast cancer receiving adjuvant
goserelin and endocrine therapy (SABCS abstract #S1-2; December 7, 9:15 -
11:30AM) and five-year ZO-FAST (ZOmeta-Femara Adjuvant Synergy Trial)
follow-up data on long-term overall survival outcomes among postmenopausal
women with hormone receptor-positive early breast cancer receiving adjuvant
zoledronic acid and letrozole (SABCS abstract #S1-3; December 7, 9:15 -
11:30AM).
* BKM120 - Two studies investigating the activity of BKM120, a pan-PI3K
inhibitor, in advanced breast cancer: data from a trial evaluating the
safety profile and clinical activity of BKM120 as a single agent for the
treatment of patients with metastatic breast cancer (SABCS abstract #P3-
16-01; December 8, 5:00 - 7:00PM) and data from a Phase I/II study
evaluating BKM120 in combination with trastuzumab in patients with HER2
overexpressing metastatic breast cancer resistant to trastuzumab-containing
therapy (SABCS abstract #PD09-03; December 9, 5:00 - 7:00PM).
Highlights at ASH include:
* Tasigna - ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical
Trials) 36-month update of the ENESTnd study comparing Tasigna to Glivec in
patients with newly diagnosed chronic phase Ph+ chronic myeloid leukemia
(ASH abstract #452; December 12, 10:30AM - 12:00PM) and results from
ENESTcmr trial assessing the efficacy and safety of switching patients with
residual molecular disease on Glivec(®) (imatinib)(2) treatment to Tasigna
(ASH abstract #606; December 12, 2:45 - 4:15PM).
* Exjade - Data from the first randomized, placebo-controlled study evaluating
the reduction of liver iron concentration and serum ferritin in patients
with non-transfusion-dependent thalassemia after one year of treatment with
Exjade oral iron chelation therapy (ASH abstract #902; December 13, 7:30 -
9:00AM) and data from a retrospective analysis of hematological response
during iron chelation therapy in patients with myelodysplastic syndrome
(MDS) and aplastic anemia with transfusional iron overload (ASH abstract
#611; December 12, 2:45 - 4:15PM).
* INC424 - Data from multiple research programs will be presented, including
two pivotal Phase III studies evaluating INC424 benefit versus placebo
(COMFORT-I [COntrolled MyeloFibrosis study with ORal JAK inhibitor Therapy])
(ASH abstract #278; December 12, 7:00 - 8:30AM) and versus best available
therapy (COMFORT-II) (ASH abstract #795; December 12, 4:30 - 6:00PM). These
data will assess measures of spleen reduction, symptom improvement, health-
related quality of life and overall survival.
* Everolimus - Results from a Phase II study evaluating everolimus as a
monotherapy in relapsed/refractory Hodgkin lymphoma (ASH abstract #2717;
December 11, 6:00 - 8:00PM) and data from a Phase I trial of everolimus in
combination with rituximab or in combination with BTZ and rituximab in
relapsed/refractory Waldenström's macroglobulinemia (ASH abstract #2705;
December 11, 6:00 - 8:00PM).
* LBH589 - Results from PANORAMA-2 (PANobinostat ORAl in Multiple myelomA), a
Phase II study of LBH589 in combination with BTZ and dexamethasone in
patients with relapsed and BTZ-refractory multiple myeloma (ASH abstract
#814; December 12, 4:30 - 6:00PM). Data from two trials in myelofibrosis:
final results from a Phase I trial of prolonged low dose therapy with LBH589
in myelofibrosis patients (ASH abstract #794; December 12, 4:30 - 6:00PM)
and a preclinical study of LBH589 in combination with INC424 in JAK2V617F-
driven disease (ASH abstract #798; December 12, 4:30 - 6:00PM).
About everolimus tablets
Everolimus is approved as Afinitor(®) (everolimus) tablets in more than 80
countries including the United States and throughout the European Union in the
oncology settings of advanced renal cell carcinoma (RCC) following progression
on or after vascular endothelial growth factor (VEGF)-targeted therapy and in
the US and EU for locally advanced, metastatic or unresectable progressive
neuroendocrine tumors of pancreatic origin (pNET).
Everolimus is also available from Novartis for use in non-oncology patient
populations under the brand names Afinitor(®) or Votubia(®), 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. Access to everolimus outside of the approved indications is carefully
controlled and monitored in clinical trials designed to better understand the
potential benefits and risks of the compound. As an investigational compound,
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.
Everolimus tablets Important Safety Information
Everolimus 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. Everolimus can affect blood cell counts, kidney
and liver function, and blood sugar and cholesterol levels. Everolimus may cause
fetal harm in pregnant women. Women taking everolimus 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, and
diabetes. Cases of hepatitis B reactivation and blood clot in the lung and leg
have been reported.
About Zometa (zoledronic acid)
Zometa(®) (zoledronic acid) Injection is indicated for the prevention of
skeletal-related events (SREs; pathological fractures, spinal compression,
radiation or surgery to bone, or tumor-induced hypercalcemia) in patients with
multiple myeloma and advanced malignancies involving bone. The recommended dose
is a 4 mg, 15-minute infusion every 3-4 weeks.
Zometa Important Safety Information
Zometa has been associated with reports of renal insufficiency. Adequately
rehydrate patients and assess serum creatinine prior to each dose. Single doses
of Zometa should not exceed 4 mg and the duration of infusion should be no less
than 15 minutes in 100 ml of dilutent. The risk of renal adverse events may be
greater in patients with renal insufficiency and dose adjustments are required.
Not recommended in patients with severe renal impairment. Monitor serum levels
of calcium, phosphate and magnesium and treat as necessary. Severe and
occasionally incapacitating bone, joint, and/or muscle pain has been reported.
Monitor for thigh, hip or groin pain, evaluate for femur fractures as necessary
and discontinue treatment if required. Use caution in aspirin-sensitive
patients, and when using aminoglycosides, loop diuretics and other potentially
nephrotoxic drugs. Use caution in multiple myeloma patients using thalidomide.
Patients being treated with Zometa should not be treated with Aclasta(3)
concomitantly. Zometa should not be used in patients who are pregnant, or plan
to become pregnant, or who are breast-feeding. Contraindicated in patients with
hypersensitivity to zoledronic acid, other bisphosphonates, or any of the
excipients in Zometa.
In clinical trials, the most commonly reported adverse events included flu-like
syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue,
gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema.
Osteonecrosis of the Jaw (ONJ): ONJ has been reported in patients with cancer
receiving treatment including bisphosphonates, chemotherapy, and/or
corticosteroids. The majority of reported cases have been associated with dental
procedures such as tooth extraction. A dental examination with appropriate
preventive dentistry should be considered prior to treatment with
bisphosphonates in patients with concomitant risk factors. While on treatment,
these patients should avoid invasive dental procedures if possible. No data are
available to suggest whether discontinuation of bisphosphonate therapy reduces
the risk of ONJ in patients requiring dental procedures. A causal relationship
between bisphosphonate use and ONJ has not been established.
Please see full Prescribing Information. Approved indications vary by country.
About BKM120 and LBH589 (panobinostat)
Because these are investigational compounds, the safety and efficacy profile of
BKM120 and LBH589 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 BKM120 and LBH589 will ever be commercially available anywhere
in the world.
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 Glivec, and 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 indicated for the treatment of chronic iron overload
due to blood transfusions (transfusional hemosiderosis) in adult and pediatric
patients (aged 2 years and over). It is approved in over 100 countries including
the U.S., Switzerland, Japan, and the countries comprising the European Union.
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 INC424 (ruxolitinib)
INC424 (ruxolitinib) is an oral inhibitor, of the JAK1 and JAK2 tyrosine
kinases. INC424 is being investigated in primary myelofibrosis as well as post-
polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia
myelofibrosis (PET-MF). INC424 is also being investigated in clinical trials for
the treatment of polycythemia vera (PV).()
Novartis licensed INC424 from Incyte for development and potential
commercialization outside the US. Incyte has retained rights for the development
and potential commercialization of INC424 in the US. Both the US Food and Drug
Administration and the European Medicines Agency have granted INC424 orphan drug
status for myelofibrosis.
(1) Novartis and Incyte Corporation have a worldwide collaboration and licensing
agreement for INC424.
(2) Known as Gleevec(®) (imatinib mesylate) tablets in the US, Canada and
Israel.
(3) Known as Reclast in the US.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will," "goal," "potential," or similar expressions, or
by express or implied discussions regarding potential new indications or
labeling, or potential marketing approvals for Novartis Oncology 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
additional indications or labeling will be approved for any existing Novartis
Oncology products, or that any new Novartis Oncology products will be approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that any such products will achieve any particular levels of revenue
in the future. In particular, management's expectations 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; the
company's ability to obtain or maintain patent or other proprietary intellectual
property protection; competition in general; government, industry and general
public pricing pressures; 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 2010, the Group's
continuing operations achieved net sales of USD 50.6 billion, while
approximately USD 9.1 billion (USD 8.1 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
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References
[1] San Antonio Breast Cancer Symposium. SABCS Annual '11 Meeting Program.
Available athttp://www.sabcs.org/ProgramSchedule/index.asp. Accessed November
2011.
[2] American Society of Hematology. ASH Annual '11 Meeting Program. Available
athttp://ash.confex.com/ash/2011/webprogram/start.html. Accessed November 2011.
# # #
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