Data at ASCO show promise of Novartis drugs for patients with life-threatening diseases like CML, multiple myeloma and breast cancer
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Novartis International AG / Data at ASCO show promise of Novartis drugs for patients with life-threatening diseases like CML, multiple myeloma and breast cancer processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Eighteen-month results for Tasigna® in first-line treatment for patients
with newly diagnosed chronic myeloid leukemia
* Two separate Phase III studies with Zometa® in multiple myeloma and adjuvant
breast cancer
* Phase II data with Afinitor® in SEGA brain tumors associated with tuberous
sclerosis in children and adults
* Pipeline data, including panobinostat (LBH589), PI3K Inhibitors BEZ235 and
BKM120, and LDE225, underscore strength of the Novartis Oncology pipeline
Basel, June 2, 2010 - Novartis today announced that nearly 170 abstracts
highlighting investigational uses of current therapies and investigational
agents in the Novartis Oncology portfolio will be presented at the 46(th) Annual
Meeting of the American Society of Clinical Oncology (ASCO) from June 4 through
June 8 in Chicago, IL[1]. These data include results with Tasigna(®)
(nilotinib), Zometa(®) (zoledronic acid), Afinitor(®) (everolimus) tablets,
panobinostat (LBH589) and targeted pipeline therapies that underscore the
Company's dedication to improving treatment for cancer patients around the world
by developing therapies based on the molecular pathways of various cancers and
tumor types.
"Our scientific presence at ASCO speaks to our commitment to improve cancer
treatment by discovering, developing and making available individualized
therapies for diseases where there is unmet medical need," said Herve Hoppenot,
President, Novartis Oncology. "Through our robust discovery and development
program, we will continue to be a leader in the oncology community, working to
bring forth significant treatment advances that strive to improve the lives of
patients suffering from cancer."
Notable data with Novartis treatments include the following oral presentations.
* Abstract #6501: 18-month (median follow-up) study results with Tasigna in
adult patients with newly diagnosed Philadelphia chromosome-positive chronic
myeloid leukemia (Ph+ CML) in chronic phase[2].
* Abstract #8021: Results from a large, Phase III study evaluating the
addition of Zometa to chemotherapy versus oral clodronate plus chemotherapy
in patients with newly diagnosed multiple myeloma[3].
* Abstract #2004: Findings on everolimus in patients with subependymal giant
cell astrocytomas (SEGAs) associated with tuberous sclerosis (TS), a genetic
disorder which causes tumors to form in many vital organs, including the
brain[4],[5]. There are currently no FDA-approved treatments, although
invasive brain surgery can be used to remove tumors[4].
* Two oral presentations will highlight panobinostat (LBH589) in Hodgkin
lymphoma and multiple myeloma. Interim results from a Phase II study
(abstract #8007) of panobinostat in heavily pre-treated patients with
relapsed/refractory Hodgkin lymphoma and updated data from a Phase Ib study
(abstract #8001) of oral panobinostat in combination with bortezomib in
patients with relapsed or relapsed and refractory multiple myeloma will be
presented[6],[7]. Also, Novartis will present PANORAMA-2, a new Phase II
study (abstract #TPS308) on panobinostat in bortezomib-refractory multiple
myeloma patients[8].
Data from the Novartis Oncology pipeline include innovative, targeted therapies
in various solid tumor types.
* Abstract #3005: Results from the first-in-human Phase I study of the oral
PI3K inhibitor BEZ235 in patients with advanced solid tumors[9].
* Abstract #3003: Phase I dose-escalation study of BKM120, an oral pan-class I
PI3K inhibitor, in advanced solid tumors[10].
* Abstract #2500: Phase I dose-escalation study of LDE225, a smoothened
antagonist, in solid tumors[11].
Other key studies being presented at ASCO underscore Novartis Oncology's
commitment to exploring the potential of currently approved products in areas of
unmet patient need, including[1]:
* Abstract #6515: 24-month update of the GIMEMA Phase II trial will reveal the
efficacy and safety results of Tasigna 800 mg daily in early chronic phase
Ph+ CML[12].
* Abstract #533: Data from a five-year update of the ABCSG-12 study evaluating
the addition of Zometa to hormonal therapy following surgery on disease-free
survival in premenopausal women with ER-positive early breast cancer[13].
* Abstract #1013: Interim results from a Phase II trial that evaluated
progression-free survival data when everolimus is added to paclitaxel and
trastuzumab in patients with human epidermal growth factor receptor 2
positive (HER2+) metastatic breast cancer with prior resistance to
trastuzumab and taxanes[14]. Based on earlier results of these data, a Phase
III trial BOLERO-1 is currently underway to evaluate the potential of
everolimus in women with HER2+ breast cancer.
About Tasigna
Tasigna has been approved in more than 80 countries for the treatment of chronic
phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to
at least one prior therapy, including Glivec. The effectiveness of Tasigna for
this indication is based on confirmed hematologic and unconfirmed cytogenetic
response rates. There are no controlled trials demonstrating a clinical benefit,
such as improvement in disease-related symptoms or increased survival.
Tasigna is not approved for the treatment of newly diagnosed Ph+ CML-CP.
Tasigna important safety information
Because taking Tasigna with food may increase the amount of drug in the blood,
Tasigna should not be taken with food and patients should wait at least two
hours after a meal before taking Tasigna. In addition, no food should be
consumed for at least one hour after the dose is taken.
The most frequent Grade 3 or 4 adverse events for Tasigna were primarily
hematological in nature and included neutropenia and thrombocytopenia.
Elevations seen in bilirubin, liver function tests, lipase enzymes and blood
sugar, were mostly transient and resolved over time. These cases were easily
managed and rarely led to discontinuation of treatment. Pancreatitis was
reported in less than 1% of cases. The most frequent non-hematologic
drug-related adverse events were rash, pruritus, nausea, fatigue, headache,
constipation and diarrhea. Most of these adverse events were mild to moderate in
severity.
Tasigna should be used with caution in patients with uncontrolled or significant
cardiac disease (e.g., recent heart attack, congestive heart failure, unstable
angina or clinically significant bradycardia), as well as in patients who have
or may develop prolongation of QTc. These include patients with abnormally low
potassium or magnesium levels, patients with congenital long QT syndrome,
patients taking anti-arrhythmic medicines or other drugs that may lead to QT
prolongation. Low levels of potassium or magnesium must be corrected prior to
Tasigna administration. Close monitoring for an effect on the QTc interval is
advisable and a baseline echocardiogram is recommended prior to initiating
therapy with Tasigna and as clinically indicated.
About Glivec
Glivec is approved in more than 90 countries, including the US, EU and Japan,
for the treatment of all phases of Ph+ CML. Glivec is also approved in the US,
EU and other countries for the treatment of patients with Kit (CD117)-positive
gastrointestinal tumors (GIST), which cannot be surgically removed and/or have
already spread to other parts of the body (metastasized). In the US and EU,
Glivec is now approved for the post-surgery treatment of adult patients
following complete surgical removal of Kit (CD117)-positive gastrointestinal
stromal tumors. In the EU, Glivec is also approved for the treatment of adult
patients with newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in
combination with chemotherapy and as a single agent for patients with relapsed
or refractory Ph+ ALL. Glivec is also approved for the treatment of adult
patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma
protuberans (DFSP) who are not eligible for surgery. Glivec is also approved for
the treatment of patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chronic
eosinophilic leukemia (HES/CEL).
The effectiveness of Glivec is based on overall hematological and cytogenetic
response rates and progression-free survival in CML, on hematological and
cytogenetic response rates in Ph+ ALL, MDS/MPD, on hematological response rates
in systemic mastocytosis (SM), HES/CEL, on objective response rates and
progression-free survival in unresectable and/or metastatic GIST, on recurrence
free survival in adjuvant GIST and on objective response rates in DFSP.
Increased survival in controlled trials has been demonstrated only in newly
diagnosed chronic phase CML and GIST.
Not all indications are available in every country.
Glivec important safety information
The majority of patients treated with Glivec in clinical trials experienced
adverse events at some time. Most events were of mild to moderate grade and
treatment discontinuation was not necessary in the majority of cases.
The safety profile of Glivec was similar in all indications. The most common
side effects included nausea, superficial edema, muscle cramps, skin rash,
vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue,
headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis,
eczema and fluid retention, as well as neutropenia, thrombocytopenia and anemia.
Glivec was generally well tolerated in all of the studies that were performed,
either as monotherapy or in combination with chemotherapy, with the exception of
a transient liver toxicity in the form of transaminase elevation and
hyperbilirubinemia observed when Glivec was combined with high dose
chemotherapy.
Rare/serious adverse reactions include: sepsis, pneumonia, depression,
convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic
failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal
failure, fluid retention, edema (including brain, eye, pericardium, abdomen and
lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract),
diverticulitis, gastrointestinal perforation, tumor hemorrhage/necrosis and hip
osteonecrosis/avascular necrosis.
Patients with cardiac disease or risk factors for cardiac failure should be
monitored carefully and any patient with signs or symptoms consistent with
cardiac failure should be evaluated and treated. Cardiac screening should be
considered in patients with HES/CEL, and patients with MDS/MPD with high level
of eosinophils (echocardiogram, serum troponin level).
Glivec is contraindicated in patients with known hypersensitivity to imatinib or
any of its excipients. Women of childbearing potential should be advised to
avoid becoming pregnant while taking Glivec.
About Zometa
Zometa is indicated for the prevention of skeletal related events (pathological
fractures, spinal compression, radiation or surgery to bone, or tumor-induced
hypercalcemia) in patients with advanced malignancies involving bone. An
intravenous bisphosphonate, Zometa is the only therapy to demonstrate efficacy
in reducing or delaying bone complications across a broad range of tumor types
such as breast, prostate, lung and renal cell cancers, in patients with
metastatic disease when administered monthly. Zometa offers patients, nurses and
clinicians a 4 mg, 15-minute infusion.
Zometa is the world's leading treatment for the prevention or delay of
skeletal-related events (SREs) in patients with advanced malignancies involving
bone across a broad range of tumors. Laboratory research has suggested that
Zometa may also help protect patients from the spread of cancer to other parts
of the body (distant metastatic sites) and help keep patients recurrence-free.
Zometa important safety information
Zometa has been associated with reports of renal insufficiency. Patients should
be adequately rehydrated and have their serum creatinine assessed prior to
receiving each dose of Zometa. Due to the risk of clinically significant
deterioration in renal function, 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. Severe and occasionally incapacitating bone, joint, and/or muscle pain
has been reported in patients taking bisphosphonates including Zometa. Caution
is advised when Zometa is used in aspirin-sensitive patients, or with
aminoglycosides, loop diuretics and other potentially nephrotoxic drugs. Zometa
contains the same active ingredient (zoledronic acid) as found in Aclasta.
Patients being treated with Zometa should not be treated with Aclasta
concomitantly.
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. Zometa
should not be used during pregnancy. Zometa is contraindicated in patients with
clinically significant hypersensitivity to zoledronic acid or other
bisphosphonates, or any of the excipients in the formulation of Zometa.
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.
About everolimus
In the European Union (EU), everolimus is approved under the trade name
Afinitor® (everolimus) tablets for the treatment of patients with advanced renal
cell carcinoma (RCC) whose disease has progressed on or after treatment with
vascular endothelial growth factor (VEGF)-targeted therapy. In the US, Afinitor
is approved for the treatment of patients with advanced RCC after failure of
treatment with sunitinib or sorafenib.
In the EU, everolimus is available in different dosage strengths under the trade
name Certican® for the prevention of organ rejection in heart and kidney
transplant recipients. In the US, everolimus is available in different dosage
strengths under the trade name Zortress® for the prophylaxis of organ rejection
in adult patients at low-moderate immunologic risk receiving a kidney
transplant.
As an investigational compound, the safety and efficacy profile of everolimus
has not yet been established in cancer and tumor types outside of the approved
advanced renal cell carcinoma indication. Access to everolimus for cancer and
tumor types is available through carefully controlled and monitored clinical
trials. These trials are designed to better understand the potential benefits
and risks of the compound. For more information about everolimus clinical
trials, healthcare professionals can visitwww.theWIDEprogram.com
there is no guarantee that everolimus will become commercially available for
cancer and tumor types anywhere in the world.
Afinitor (everolimus) tablets important safety information
Afinitor is contraindicated in patients with hypersensitivity to everolimus, to
other rapamycin derivatives or to any of the excipients.
Cases of non-infectious pneumonitis have been described; some of these have been
severe and occasionally fatal. Management of pneumonitis may require dose
adjustment and/or interruption, or discontinuation of treatment and/or addition
of corticosteroid therapy.
Afinitor is immunosuppressive. Localized and systemic bacterial, fungal, viral
or protozoal infections (e.g. pneumonia, aspergillosis, candidiasis, hepatitis B
reactivation) have been described; some of these have been severe and
occasionally fatal. Pre-existing infections should be treated prior to starting
treatment. Patients should be vigilant for symptoms and signs of infection; in
case of emergent infections, appropriate treatment should be promptly instituted
and interruption or discontinuation of Afinitor should be considered. Patients
with systemic invasive fungal infections should not receive Afinitor.
Mouth ulcers, stomatitis and oral mucositis have been seen in patients treated
with Afinitor. Monitoring of renal function, blood glucose and complete blood
counts is recommended prior to initiation and periodically during treatment.
Afinitor is not recommended in patients with severe hepatic impairment. Use of
live vaccines should be avoided. Afinitor is not recommended during pregnancy or
for women of childbearing potential not using contraception. Afinitor may cause
fetal harm in pregnant women. Women taking Afinitor should not breast feed.
Avoid concurrent treatment with strong CYP3A4 and PgP inhibitors and use caution
with moderate inhibitors. Avoid concurrent treatment with strong CYP3A4 or PgP
inducers.
The most common adverse reactions (=10%) include stomatitis, rash, fatigue,
asthenia, diarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough,
infections, peripheral edema, dry skin, epistaxis, pneumonitis, pruritus,
dyspnea and dysgeusia. Common adverse reactions (=1 to <10%) include headache,
dry mouth, pyrexia, weight decreased, hand-foot syndrome, abdominal pain,
erythema, insomnia, dyspepsia, dysphagia, hypertension, increased daytime
urination, dehydration, chest pain, hemoptysis and exacerbation of diabetes
mellitus. Uncommon adverse reactions (<1%) include ageusia, congestive cardiac
failure, new-onset diabetes mellitus, impaired wound healing, grade 1 hemorrhage
and hepatitis B reactivation.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "promise," "pipeline," "will," "dedication,"
"commitment," "potential," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling, or potential
marketing approvals for the products described in this release, 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 products or additional indications or labeling described in this release
will be submitted for approval or approved for sale in any market. Nor can there
be any guarantee that any of these products or indications will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding these products and indications 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; 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 healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com
References
[1] American Society of Clinical Oncology. Annual '10 Meeting, Annual Meeting
Program. Available
at:http://chicago2010.asco.org/MeetingProgram.aspx#OPP.http://www.thelamfoundati
on.org/medical-providers/hrct-screening.html Accessed May 2010.
[2] Larson R, et al. Nilotinib is Superior to Imatinib in Patients (pts) with
Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP): ENESTnd
Beyond 1 Year. Presented at: American Society of Clinical Oncology 2010 Annual
Meeting. Abstract No. 6501.
[3] Morgan, G. et al, Evaluating the Effects of Zoledronic Avis on Overall
Survival in patients with multiple Myeloma: Results of the Medical Research
Council Myeloma IX Study. Presented at: American Society of Clinical Oncology
2010 Annual Meeting. Abstract No. 8021.
[4] Franz DN, et al. Everolimus for subependymal giant-cell astrocytomas (SEGAs)
in tuberous sclerosis (TS). Presented at: American Society of Clinical Oncology
2010 Annual Meeting. Abstract No. 2004.
[5] National Institute of Neurological Disorders and Stroke. National Institute
of Health. Available
athttp://www.ninds.nih.gov/disorders/tuberous_sclerosis/detail_tuberous_sclerosi
s.htm. Accessed May 2010.
[6] Sureda A, et al. Interim results for the phase II study of panobinostat
(LBH589) in patients (Pts) with relapsed/refractory Hodgkin's lymphoma (HL)
after autologous hematopoietic stem cell transplant (AHSCT). Presented at:
American Society of Clinical Oncology 2010 Annual Meeting. Abstract No. 8007.
[7] San-Miguel JF, et al. Phase Ib study of oral panobinostat (LBH589) plus
intravenous bortezomib in patients (Pts) with relapsed (Rel) or Rel and
refractory (Ref) multiple myeloma (MM). Presented at: American Society of
Clinical Oncology 2010 Annual Meeting. Abstract No. 8001.
[8] Alsina M, et al. PANORAMA 2: A phase II study of panobinostat (LBH589) in
combination with bortezomib (BTZ) and dexamethasone (DEX) in patients with
relapsed and BTZ-refractory multiple myeloma (MM). Presented at: American
Society of Clinical Oncology 2010 Annual Meeting. Abstract No. TPS308.
[9] Buris H, et al. First-in-human phase I study of the oral PI3K inhibitor
BEZ235 in patients (pts) with advanced solid tumors. Presented at: American
Society of Clinical Oncology 2010 Annual Meeting. Abstract No. 3005.
[10] Baselga J, et al. A first-in-human phase I study of BKM120, an oral
pan-class I PI3K inhibitor, in patients (pts) with advanced solid tumors.
Presented at: American Society of Clinical Oncology 2010 Annual Meeting.
Abstract No. 3003.
[11] Rodon Ahnert J, et al. A phase I dose-escalation study of LDE225, a
smoothened (Smo) antagonist, in patients with advanced solid tumors. Presented
at: American Society of Clinical Oncology 2010 Annual Meeting. Abstract No.
2500.
[12] Rosti G, Castagnetti F., Palandri F.,.et al. Efficacy and safety of
nilotinib 800 mg daily in early chronic phase Ph+ chronic myeloid leukemia:
Results of a phase II trial at 2 years. Presented at: American Society of
Clinical Oncology 2010 Annual Meeting. Abstract 6515.
[13] Gnant, M et al, Mature results from ABCSG-12: Adjuvant ovarian suppression
combined with tamoxifen or anastrozole, alone or in combination with zoledronic
acid, in premenopausal women with endocrine-responsive early breast cancer.
Presented at: American Society of Clinical Oncology 2010 Annual Meeting.
Abstract No. 533.
[14] Dalenc, et al. Everolimus in combination with weekly paclitaxel and
trastuzumab in patients (pts) with HER2-overexpressing metastatic breast cancer
(MBC) with prior resistance to trastuzumab and taxanes: A multicenter phase II
clinical trial. Presented at: American Society of Clinical Oncology 2010 Annual
Meeting. Abstract No. 1013.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Megan Humphrey
Novartis Global Media Relations Novartis Oncology
+41 61 324 7999 (direct) +1 862 778 6724 (direct)
+41 79 593 4202 (mobile) megan.humphrey(at)novartis.com
eric.althoff(at)novartis.com
e-mail:media.relations(at)novartis.com
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Central phone: +41 61 324 7944
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Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
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