Phase III study shows Novartis drug Afinitor® more than doubles time without tumor growth in advanced pancreatic NET patients
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* Everolimus extended median progression-free survival from 4.6 to 11.0 months
vs. placebo and reduced risk of cancer progression by 65%[1]
* Patients with advanced pancreatic neuroendocrine tumors (NET) have a rare
and aggressive form of cancer with limited treatment options[2,3]
* Worldwide regulatory filings planned for everolimus as first mTOR inhibitor
treatment for patients with advanced pancreatic NET
Basel, July 1, 2010 - Novartis announced today that results of a Phase III study
show Afinitor(®) (everolimus) tablets plus best supportive care (BSC) more than
doubled progression-free survival, or time without tumor growth, versus placebo
plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The
study, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors), was presented at
the 12(th) World Congress on Gastrointestinal Cancer and is part of the largest
clinical trial program in patients with advanced NET[1]().
Afinitor( )is approved 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[4].
Findings from the RADIANT-3 study demonstrated that everolimus extended the
median time without tumor growth from 4.6 to 11.0 months when compared with
placebo. Additionally, the data showed everolimus reduced the risk of cancer
progression by 65% (hazard ratio=0.35 [95% confidence interval, 0.27 to 0.45];
p<0.0001)[1].
"It's encouraging to see that by targeting the mTOR pathway, treatment with
everolimus can provide a significant progression-free survival advantage over
placebo in patients with advanced pancreatic NET," said James Yao, MD, Associate
Professor of Medicine, The University of Texas MD Anderson Cancer Center. "These
results further validate earlier trials and demonstrate the potential benefit
everolimus can provide to these patients."
Pancreatic NET can grow aggressively and at time of diagnosis nearly 60% of all
patients have advanced disease, meaning the cancer has spread to other parts of
the body and has become more difficult to treat[2,3]. The median overall
survival for patients with advanced pancreatic NET is 24 months[5]. Currently,
surgery and chemotherapy are the only available treatment options for patients
with advanced pancreatic NET[2].
"Our commitment to patients with advanced NET continues with the RADIANT trial
program, which is the largest in patients with advanced NET," said Hervé
Hoppenot, President, Novartis Oncology. "With this study, Novartis continues to
make progress towards our goal of providing patients with treatment options for
this rare and hard to treat cancer."
About RADIANT-3
RADIANT-3 is a Phase III prospective, double-blind, randomized, parallel group,
placebo-controlled, multicenter study. The trial examined the efficacy and
safety of everolimus plus BSC versus placebo plus BSC in 410 patients with
advanced pancreatic NET, also known as islet cell tumors. Patients who met the
study entry criteria were randomized 1:1 to receive either daily everolimus (10
mg) or daily placebo orally[1].
The primary endpoint of RADIANT-3 is progression-free survival. Secondary
endpoints include safety, objective response rate and overall survival.
Additional study findings will be submitted for presentation at the 35(th)
European Society for Medical Oncology Congress (ESMO) in Milan, Italy later this
year.
In the study, everolimus had a safety profile consistent with previous studies
of this drug. Adverse events observed (>20%) in the everolimus arm included
stomatitis (53.9%), rash (52.5%), diarrhea (46.6%), fatigue (43.6%), edema
peripheral (35.8%), nausea (31.9%), headache (29.9%), pyrexia (29.4%), decreased
appetite (28.9%), vomiting (28.4%), weight loss (27.9%), abdominal pain (23.5%),
anemia (22.1%), cough (21.6%) and epistaxis (21.1%)[1].
About neuroendocrine tumors (NET)
Neuroendocrine tumors arise from cells that can produce and secrete a variety of
hormones that regulate bodily functions. There are many types of NET that can
occur throughout the body; however, most are found in the gastrointestinal
tract, pancreas and lungs[5](). Because NET are relatively rare, there is no
routine screening and patients often experience delays of five to seven years
before receiving an accurate diagnosis[5,6]. As a result of this, patients with
NET often have advanced disease when diagnosed[6](). Although considered a rare
cancer, the incidence of NET is increasing dramatically, having quadrupled in
the past 30 years[5].
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 prevention of rejection of
kidney transplants in adult patients at low-to-moderate immunologic risk.
With once-daily dosing Afinitor works by targeting mTOR in cancer cells, a
protein that acts as a central regulator of tumor cell division, blood vessel
growth and cell metabolism.
As an investigational compound the safety and efficacy profile of everolimus has
not yet been established in NET. Access to everolimus for NET has been carefully
controlled and monitored in clinical trials designed to better understand the
potential benefits and risks of the compound. For more information about ongoing
everolimus clinical trials, healthcare professionals can visit
www.theWIDEprogram.com. Because of the uncertainty of clinical trials, there is
no guarantee that everolimus will become commercially available for NET 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 and physicians 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 loss, 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 "risk," "planned," "encouraging," "can," "potential,"
"commitment," "goal," "will," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling for Afinitor or
regarding potential future revenues from Afinitor. 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 Afinitor to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that Afinitor will be submitted or approved for any additional indications or
labeling in any market. Nor can there be any guarantee that Afinitor will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding Afinitor 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] Yao, et al. Everolimus versus placebo in patients with advanced pancreatic
neuroendocrine tumors (pNET) (RADIANT-3). 12th World Congress on
Gastrointestinal Cancer, Barcelona. July 1, 2010.
[2] National Library of Medicine and the National Institutes of Health.
Pancreatic islet cell tumor. Available
athttp://www.nlm.nih.gov/medlineplus/ency/article/000393.htm. Accessed May 2010.
[3] Halfdanarson, et al. Pancreatic neuroendocrine tumors (PNETs): incidence,
prognosis and recent trend toward improved survival. Annals of Onc
19: 1727-1733, 2008.
[4] Afinitor(® )(everolimus) tablets EU summary of product characteristics.
Basel, Switzerland: Novartis International AG; August 2009.
[5] Yao, et al. One Hundred Years After "Carcinoid:" Epidemiology of and
Prognostic Factors for Neuroendocrine Tumors in 35,825 Cases in the United
States. Journal of Clinical Oncology. June 20 2009; vol. 26, number 18.
[6] Modlin, et al. Priorities for Improving the Management of
Gasteroenteropancreatic Neuroendocrine Tumors. J Natl Cancer Inst
2008;100:1282-1289.
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Datum: 01.07.2010 - 07:15 Uhr
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