Novartis drug Glivec® shows significant overall survival benefit for patients with GIST after three years of adjuvant treatment vs. one year

Nachrichtenquelle: GlobeNewswire
05.06.2011, 15:00  |  6024   |   |   


Novartis International AG /
Novartis drug Glivec® shows significant overall survival benefit for patients
with GIST after three years of adjuvant treatment vs. one year
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.

* Data show 66% recurrence-free survival and 92% overall survival at five
years following three years of adjuvant therapy with Glivec in patients with
resected KIT+ GIST[1]

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* First large Phase III clinical trial to demonstrate survival benefits of
extended treatment with Glivec for three years compared to one year
following surgery

* Important finding for treatment of GIST patients who are at risk of
recurrence following complete resection of primary tumor

Basel, June 5, 2011 - Novartis announced new data today showing a significant
improvement in both recurrence-free survival and overall survival for patients
taking Glivec(®) (imatinib)* for three years after surgery to remove KIT
(CD117)-positive gastrointestinal stromal tumors (GIST) compared to one year of
treatment. These data will be presented at the 47th American Society of Clinical
Oncology (ASCO) plenary session on Sunday, June 5.

The results show that at five years 66% of patients taking Glivec for three
years remained free of cancer recurrence (primary endpoint) compared to 48% who
had received Glivec for only one year (p<.0001). Moreover, 92% of patients
taking Glivec for three years were alive (secondary endpoint) compared to 82%
who had received Glivec for only one year (p=.019). Median patient follow-up was
54 months.[1]

The 400-patient Phase III trial, conducted by the Scandinavian Sarcoma Group
(SSG) and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie
(AIO), is the first prospective multicenter clinical trial to demonstrate a
survival benefit of adjuvant Glivec therapy for KIT+ GIST with extended three
years of therapy relative to one year of therapy. The side effect profile in the
clinical trial was consistent with that reported in previous studies with
Glivec.

"This study confirms the hypothesis that extending the duration of Glivec
treatment for patients following surgery improves recurrence-free survival. For
the first time, an effect on overall survival was found, " said Heikki Joensuu,
M.D., Ph.D., Professor, Oncology, University of Helsinki and principal
investigator of the study. "Results from this trial may positively impact
clinical practice by helping physicians create the optimal treatment plan for
patients with operable KIT+ GIST."

Gastrointestinal stromal tumors are a rare, life-threatening cancer of the
gastrointestinal tract. The major cause of GIST is an abnormal form of the
protein KIT, [2] which causes cells to grow uncontrollably and become cancerous.
Patients with GIST are at risk of recurrence following complete resection of
primary GIST.[3]

"Over the past nine years Glivec has provided KIT+ GIST patients with the first
effective drug treatment option in the metastatic setting and later in the
adjuvant setting, " said Hervé Hoppenot, President, Novartis Oncology. "Now we
see exciting new data showing that by extending post-surgical treatment duration
to three years, Glivec has significant impact on overall survival in patients
with KIT+ GIST. This is important news for GIST patients and the GIST
community."

Study details
The SSG XVIII clinical trial was conducted by the Scandinavian Sarcoma Group
(SSG), and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie
(AIO). SSG XVIII is a multicenter, prospective, randomized study for the
evaluation of adjuvant treatment with Glivec of histologically verified KIT+
GIST with a greater than 50% risk of GIST recurrence despite complete removal of
all macroscopic GIST tissue at surgery.[4]

The primary endpoint of the study was to compare the recurrence-free survival in
GIST patients with a greater than 50% estimated risk of disease recurrence
within the first five years following the diagnosis and treatment with adjuvant
Glivec for 12 or 36 months. The secondary endpoints included overall survival
and treatment safety.[1]

Four hundred patients entered the study and the median follow-up was 54 months.
Recurrence-free survival was longer in the 36-month group compared to the 12-
month group (HR 0.46, 95% CI 0.32-0.65; p<.0001; five-year recurrence-free
survival 66% vs. 48%, respectively). Patients assigned to 36 months of Glivec
had longer overall survival (HR 0.45, 95% CI 0.22-0.89; p=.019; five-year
overall survival 92% vs. 82%, respectively). Glivec was generally well
tolerated. The proportion of patients who discontinued Glivec during the
assigned treatment period for reasons other than GIST recurrence was 26% in the
36-month group and 13% in the 12-month group.[1]

About Glivec
Glivec is approved in more than 110 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 stromal 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 approved for the post-surgery treatment of adult patients
following complete surgical removal of KIT (CD117)-positive gastrointestinal
stromal tumors.

Not all indications are available in every country and indications may differ.

Glivec Important Safety Information
Glivec can cause fetal harm when administered to a pregnant woman. Women should
not become pregnant, and should be advised of the potential risk to the unborn
child.

Glivec is often associated with edema (swelling) and serious fluid retention.
Studies have shown that edema (swelling) tended to occur more often among
patients who are 65 and older or those taking higher doses of Glivec.

Cytopenias (reduction or lack of certain cell elements in blood circulation),
such as anemia, have occurred. If the cytopenia is severe, your doctor may
reduce your dose or temporarily stop your treatment with Glivec.

Severe congestive heart failure and left ventricle dysfunction have been
reported, particularly in patients with other health issues and risk factors.
Patients with heart disease or risk factors will be monitored and treated for
the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure
and severe liver injury requiring liver transplants have been reported with both
short-term and long-term use of Glivec.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in
patients with KIT+ GIST. GI tumor sites may be the cause of this bleeding.

In patients with hypereosinophilic syndrome (a condition with increased
eosinophils, which are a type of white blood cell) and heart involvement, cases
of heart disease (cardiogenic shock/left ventricular dysfunction) have been
associated with the initiation of Glivec therapy.

Skin reactions, such as fluid-filled blisters, have been reported with the use
of Glivec. Clinical cases of hypothyroidism (reduction in thyroid hormones) have
been reported in patients taking levothyroxine replacement with Glivec.

Long-term use may result in potential liver, kidney, and/or heart toxicities;
immune system suppression may also result from long-term use.

GI perforation (small holes or tears in the walls of the stomach or intestine),
in some cases fatal, has been reported.

Growth retardation has been reported in children taking Glivec. The long-term
effects of extended treatment with Glivec on growth in children are unknown.

Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte
disturbance caused by the breakdown of tumor cells, have been reported and can
be life-threatening in some cases.

Almost all patients with KIT+ GIST treated with Glivec experience side effects
at some time. Some common side effects you may experience are fluid retention,
muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting,
diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.

Glivec is sometimes associated with stomach or intestinal irritation. Glivec
should be taken with food and a large glass of water to minimize this problem.
There have been rare reports, including deaths, of stomach or intestinal
perforation (a small hole or tear).

If you are experiencing any of the mentioned side effects, please be sure to
speak with your doctor immediately.

Do not take any other medications without talking to your doctor or pharmacist
first, including Tylenol(®) (acetaminophen); herbal products (St. John´s wort,
Hypericum perforatum); Coumadin(®) (warfarin sodium); rifampin; erythromycin;
metoprolol; ketoconazole; and Dilantin(®) (phenytoin). Taking these with Glivec
may affect how they work, or affect how Glivec works.

You should also tell your doctor if you are taking or plan to take iron
supplements. Patients should also avoid grapefruit juice and other foods that
may affect how Glivec works.

Please see full Prescribing Information.

Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will, " "may, " or similar expressions, or by express or
implied discussions regarding potential new indications or labeling for Glivec
or regarding potential future revenues from Glivec. 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
with Glivec to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that Glivec will be submitted or approved for any additional indications or
labeling in any market. Nor can there be any guarantee that Glivec will achieve
any particular levels of revenue in the future. In particular, management´s
expectations regarding Glivec could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; 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, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only 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. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 119,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.

References
[1] Joensuu H, et al. Twelve vs. 36 months of adjuvant imatinib (IM) as
treatment of operable GIST with a high risk of recurrence: Final results of a
randomized trial (SSGXVIII/AIO). 47th Annual Meeting of the American Society of
Clinical Oncology. Abstract No. LBA1. June 5, 2011.
[2] Gomes AL, Bardales RH, Milanezi F, Reis RM, Schmitt F. Molecular analysis of
c-KIT and PDGFRA in GISTs diagnosed by EUS. Am J Clin Pathol. 2007
Jan;127(1):89-96.
[3] DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two
hundred gastrointestinal stromal tumors: recurrence patterns and prognostic
factors for survival. Ann Surg. 2000 Jan;231(1):51-8.
[4] Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of
Gastrointestinal Stromal Tumor (GIST). Available
athttp://clinicaltrials.gov/show/NCT00116935. Accessed on April 11, 2011.

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Novartis drug Glivec® shows significant overall survival benefit for patients with GIST after three years of adjuvant treatment vs. one year Novartis International AG / Novartis drug Glivec® shows significant overall survival benefit for patients with GIST after three years of adjuvant treatment vs. one year . Processed and transmitted by Thomson Reuters ONE. The issuer is solely …

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