Pivotal Phase III trial of Novartis drug Afinitor® met primary endpoint in study of patients with advanced pancreatic neuroendocrine tumors
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* RADIANT-3 study results show everolimus significantly extends
progression-free survival in patients with advanced pancreatic
neuroendocrine tumors (NET)
* Patients with advanced pancreatic NET have a rare and aggressive form of
cancer with limited treatment options[1],[2]
* Full results to be submitted for presentation at the European Society for
Medical Oncology annual meeting and worldwide regulatory filings planned for
2010
Basel, June 3, 2010 - Novartis announced today that a Phase III study of
Afinitor® (everolimus) tablets plus best supportive care met its primary
endpoint, showing the drug significantly extended progression-free survival, or
time without tumor growth, in patients with advanced pancreatic neuroendocrine
tumors (NET). The study, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors),
is part of the largest clinical trial program of its kind.
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.
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[1],[2]. The median survival rate
for patients with advanced pancreatic NET is 17 months[2]. Currently, surgery
and chemotherapy are the only approved treatment options for patients with
advanced pancreatic NET[1].
"Everolimus was developed to inhibit the mTOR protein, which is a critical
target in treating various cancers, including NET. Results from RADIANT-3
demonstrate that everolimus has the potential to become an important treatment
option for patients with advanced pancreatic NET, where there is a major unmet
need," said Herve Hoppenot, President, Novartis Oncology. "These study results
will serve as the basis of worldwide regulatory filings for everolimus and bring
us one step closer to our goal of offering these patients a new therapy."
Full results from the RADIANT-3 study will be submitted for presentation at the
European Society for Medical Oncology annual meeting taking place in Milan,
Italy in October. Additionally, worldwide regulatory filings are planned for
2010.
Study details
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 best supportive care versus placebo plus best
supportive care in 410 patients with advanced pancreatic NET, also known as
islet cell tumors. Patients who met the study's entry criteria were randomized
1:1 to receive either daily everolimus (10 mg) or daily placebo orally.
The primary endpoint of RADIANT-3 is progression-free survival. Secondary
endpoints include safety, objective response rate and overall survival.
About neuroendocrine tumors
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[3]. 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[3],[4]. As a result of this, patients
with NET often have advanced disease when diagnosed[3]. Although considered a
rare cancer, the incidence of NET is increasing dramatically, having quadrupled
in the past 30 years[3].
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 visitwww.theWIDEprogram.com
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 "to be submitted," "planned," "can," "potential," "will,"
"goal," 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
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] 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.
[2] Halfdanarson, et al. Pancreatic neuroendocrine tumors (PNETs): incidence,
prognosis and recent trend toward improved survival. Annals of Onc
19: 1727-1733, 2008.
[3] 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.
[4] 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: 03.06.2010 - 07:15 Uhr
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