Study in JAMA reports significant survival benefit in certain GIST patients taking Novartis drug Glivec® for three years after surgery
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Study in JAMA reports significant survival benefit in certain GIST patients
taking Novartis drug Glivec® for three years after surgery
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* First large Phase III study to demonstrate significant survival benefits of
extending treatment with Glivec for three years compared to one year
following surgery
* Important finding for treatment of KIT+ GIST patients who are at risk of
recurrence following complete resection of primary tumor
* Publication follows European Commission approval of new label based on these
data
Basel, March 27, 2012 - The Journal of the American Medical Association (JAMA)
today published a Phase III study that showed significant survival benefits for
patients meeting the study inclusion criteria who received three years of
treatment with Glivec(®) (imatinib)[1] after surgery to remove KIT (CD117)-
positive gastrointestinal stromal tumors (KIT+ GIST) compared to one year of
treatment[1]. The study results were first presented at the 47th Annual Meeting
of the American Society of Clinical Oncology (ASCO) plenary session in June
2011[2].
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 which causes cells to grow uncontrollably and become cancerous[3].
Patients with GIST are at risk of recurrence following complete resection of
primary GIST[4].
According to data published in JAMA from this international, multicenter, open-
label Phase III clinical trial, at five years, 66% of patients taking Glivec for
three years after surgery for KIT+ GIST remained free of recurrence (RFS)
compared to 48% who had received Glivec for only one year after surgery
(p<0.001; HR 0.46, 95% CI 0.32-0.65). In addition, at five years, 92% of
patients taking Glivec for three years after surgery were alive (OS) compared to
82% who had received Glivec for only one year after surgery (p=0.02; HR
0.45, 95% CI 0.22-0.89). Four hundred patients entered the study. Median patient
follow-up was 54 months[1].
Based on this data, in February 2012, the European Commission approved an update
to the Glivec label to include three years of treatment after surgery for adults
with KIT+ GIST.
"This study shows a significant recurrence-free survival benefit in adults with
KIT+ GIST from adjuvant treatment with Glivec and provides important evidence to
inform the clinical care of these patients after surgery," said Heikki Joensuu,
M.D., Ph.D., Professor, Oncology, University of Helsinki. "These data are likely
to result in a new standard of care for these patients."
About the SSG Phase III trial
This multicenter, prospective, randomized study for the evaluation of adjuvant
treatment with Glivec of histologically confirmed KIT+ GIST was conducted by the
Scandinavian Sarcoma Group (SSG) and the Sarcoma Group of the
Arbeitsgemeinschaft Internistische Onkologie (AIO)[5]. The primary endpoint was
to compare, within the first five years, recurrence-free survival in patients
with a greater than 50% estimated risk of GIST disease recurrence, following
diagnosis and treatment with adjuvant Glivec for either 12 or 36 months. The
secondary endpoints included overall survival and treatment safety[2].
Inclusion criteria for risk of recurrence was defined as tumor diameter >5.0 cm
and mitotic count >5/50 high power fields (HPFs); or tumor diameter >10.0 cm; or
tumor of any size with a mitotic count >10/50 HPFs; or tumors ruptured into the
peritoneal cavity.
Almost all patients experienced side effects while taking Glivec. Glivec was
generally well tolerated. The proportion of patients who discontinued Glivec
during the assigned treatment period for reasons other than GIST recurrence was
25.8% in the 36-month group and 13% in the 12-month group[2].
Novartis provided the study drug and supported the study financially. Additional
funding was received from the Academy of Finland, Cancer Society of Finland,
Sigrid Juselius Foundation and Helsinki University Research Funds.
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.
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. Glivec should be taken
with food and a large glass of water.
Please see full Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "positive opinion," "likely," 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 approved for any additional indications or
labeling in any market, or at any particular time. 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; 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's
continuing operations 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 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
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References
[1] Joensuu H, et al. One Versus Three Years of Adjuvant Imatinib for Operable
Gastrointestinal Stromal Tumor. JAMA. Vol 307, No.12. March 28, 2012.
[2] 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.
[3] American Cancer Society. Cancer Reference Information. Detailed Guide for
Gastrointestinal Stromal Tumors.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003103-pdf.pdf.
Accessed on January 23, 2012
[4] National Comprehensive Cancer Network (NCCN): Clinical Practice Guidelines
in Oncology: Soft Tissue. Version 2, 2011.
[5] Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of
Gastrointestinal Stromal Tumor (GIST). Available at:
http://clinicaltrials.gov/show/NCT00116935. Accessed on January 9, 2012.
# # #
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[1] Known as Gleevec(®) (imatinib mesylate) tablets in the US, Canada and
Israel.
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Datum: 27.03.2012 - 22:01 Uhr
Sprache: Deutsch
News-ID 129159
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