Novartis drug Afinitor® helps women with advanced breast cancer live significantly longer without their disease progressing
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Novartis International AG /
Novartis drug Afinitor® helps women with advanced breast cancer live
significantly longer without their disease progressing
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* Everolimus combined with hormonal therapy more than doubled time without
tumor growth and reduced risk of progression by 57% vs hormonal therapy
alone[1]
* Study shows everolimus significantly enhances benefit from hormonal therapy,
representing important advance for women with postmenopausal ER+ breast
cancer[1],[2]
* Worldwide regulatory filings planned by the end of 2011 based on these data,
marking the first submission for everolimus in breast cancer
Basel, September 26, 2011 - A pivotal Phase III study shows Afinitor(®)
(everolimus) tablets plus exemestane, a hormonal therapy, more than doubled the
time women lived without tumor growth (progression-free survival; PFS) and
significantly reduced the risk of cancer progression by 57% versus exemestane
alone in patients with advanced breast cancer[1].
"Everolimus is the first drug to show significant efficacy when combined with
hormonal therapy in women with ER+HER2- advanced breast cancer, where there
continues to be a critical unmet need," said Hervé Hoppenot, President, Novartis
Oncology. "The magnitude of benefit seen in these patients, despite their
resistance to previous hormonal therapies, shows everolimus represents a
potential important new treatment approach."
BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) examined the safety and
efficacy of everolimus in combination with exemestane versus exemestane alone in
postmenopausal women with ER+HER2- advanced breast cancer who recurred or
progressed while on or following previous treatment with hormonal therapies,
letrozole or anastrozole[1]. Findings from the trial will be presented today
during a Presidential Symposium at the 2011 European Multidisciplinary Cancer
Congress in Stockholm, Sweden.
At a pre-planned analysis, the trial met its primary endpoint of PFS showing
treatment with everolimus improved PFS to 6.9 months compared to 2.8 months
(hazard ratio 0.43 [95% confidence interval (CI): 0.35 to 0.54]; p<0.0001) by
local investigator assessment. This significant improvement was consistent
across all subgroups including number of prior therapies, presence of visceral
disease, bone metastases and prior use of chemotherapy[1].
Hormonal therapy remains the cornerstone of treatment for women with advanced
breast cancer but most women with metastatic disease do not respond to initial
treatment with hormonal therapy, and almost all initial responders develop
resistance[2],[3]. Additionally, life expectancy is significantly shortened due
to the worsening of the disease[3].
Everolimus targets mTOR in cancer cells, a protein that acts as an important
regulator of tumor cell division, blood vessel growth and cell metabolism[4].
Resistance to hormonal therapy in breast cancer has been associated with over-
activation of the mTOR pathway[3].
Data from BOLERO-2 support worldwide regulatory submissions, which are planned
by the end of 2011. Additional data from BOLERO-2 will be presented at upcoming
medical congresses this year.
Worldwide, there are approximately 220,000 newly diagnosed cases of ER+HER2-
advanced breast cancer each year[5],[6]. Everolimus is also being investigated
for the treatment of patients with HER2+ advanced breast cancer[7],[8].
About BOLERO-2
BOLERO-2 is a Phase III, randomized, double-blind, placebo-controlled,
multicenter study. The trial was conducted at 189 sites worldwide and enrolled
724 patients[1]. Patients who met the study criteria were randomized (2:1) to
receive either everolimus 10 mg/day orally (n= 485), or placebo, plus oral
exemestane 25 mg/day (n=239)[1].
The primary endpoint was PFS based on local investigator radiology assessment.
Additional analysis by an independent central radiology review committee showed
everolimus extended PFS to 10.6 months compared to 4.1 months (hazard ratio
0.36; [95% CI: 0.27 to 0.47]; p<0.0001). Other endpoints include overall
survival, overall response rate, safety, patient reported outcome, clinical
benefit rate and changes in markers of bone metabolism[1]. These data are being
evaluated and will be submitted for publication or presentation in a peer-
reviewed forum.
The side effects observed were consistent with those previously reported with
everolimus with the most common grade 3 or 4 adverse events including stomatitis
(7.7%), anemia (5.8%), dyspnea (3.9%), hyperglycemia (4.3%), fatigue (3.7%),
non-infectious pneumonitis (3.1%) and increase in liver enzymes (3.1%)[1].
About everolimus
Afinitor(®) (everolimus) tablets is approved in more than 70 countries and
regions including the United States and the European Union in the oncology
settings of advanced renal cell carcinoma (RCC) following vascular endothelial
growth factor (VEGF)-targeted therapy and advanced progressive neuroendocrine
tumors of pancreatic origin (pNET).
Everolimus is also available from Novartis for use in non-oncology patient
populations under the brand names Votubia(®), Certican(®) and Zortress(®) and is
exclusively licensed to Abbott and sublicensed to Boston Scientific for use in
drug-eluting stents.
Indications vary by country and not all indications are available in every
country. Access to everolimus outside of the approved indications has been
carefully controlled and monitored in clinical trials designed to better
understand the potential benefits and risks of the compound. As an
investigational compound, the safety and efficacy profile of everolimus has not
yet been established outside the approved indications. Because of the
uncertainty of clinical trials, there is no guarantee that everolimus will
become commercially available for additional indications anywhere else in the
world.
Important Safety Information about Afinitor (everolimus) tablets
Afinitor can cause serious side effects including lung or breathing problems,
infections, and renal failure which can lead to death. Mouth ulcers and mouth
sores are common side effects. Afinitor can affect blood cell counts, kidney and
liver function, and blood sugar and cholesterol levels. Afinitor may cause fetal
harm in pregnant women. Women taking Afinitor should not breast feed.
The most common adverse drug reactions (incidence >=15%) are mouth ulcers,
diarrhea, feeling weak or tired, skin problems (such as rash or acne),
infections, nausea, swelling of extremities or other parts of the body, loss of
appetite, headache, inflammation of lung tissue, abnormal taste, nose bleeds,
inflammation of the lining of the digestive system, weight decreased and
vomiting. The most common Grade 3-4 adverse drug reactions (incidence >=2%) are
mouth ulcers, feeling tired, low white blood cells (a type of blood cell that
fights infection), diarrhea, infections, inflammation of lung tissue, and
diabetes. Cases of hepatitis B reactivation and blood clot in the lung and leg
have been reported.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "planned," "will," "potential," or similar expressions,
or by express or implied discussions regarding potential new indications or
labeling for everolimus or regarding potential future revenues from everolimus.
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 everolimus to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantee that everolimus will be approved for any additional
indications or labeling in any market. Nor can there be any guarantee that
everolimus will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding everolimus 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 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Baselga J. Everolimus in combination with exemestane for postmenopausal
women with advanced breast cancer who are refractory to letrozole or
anastrozole: results of the BOLERO-2 phase III trial. 2011 European
Multidisciplinary Cancer Congress. Presentation of late breaking abstract No.
9LBA. September 26, 2011.
[2] Gonzalez-Angulo A. Overview of Resistance to Systematic Therapy in Patients
with Breast Cancer. Breast Cancer Chemosensitivity. Available
athttp://www.ncbi.nlm.nih.gov/books/NBK6306/. Accessed September 2011.
[3] Johnston SR. New strategies in estrogen receptor-positive breast cancer.
Clin Cancer Res 2010;16:1979-87.
[4] Motzer, et. al. Phase 3 Trial of Everolimus for Metastatic Renal Cell
Carcinoma. Cancer 2010 Sep; 116(18):4256-4265.
[5] Buckley N et al. Decision Resources: Breast Cancer Event Driven. March
2011.
[6] World Cancer Report. International Agency for Research on Cancer. Available
athttp://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=900. Accessed
September 2011.
[7] Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment
of HER2 Positive Locally Advanced or Metastatic Breast Cancer (BOLERO-1).
Available athttp://www.clinicaltrials.gov/ct2/show/NCT00876395?term=bolero-
1&rank=1. Accessed September 2011.
[8] Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu
Positive Women With Locally Advanced or Metastatic Breast Cancer (BOLERO-3).
Available athttp://www.clinicaltrials.gov/ct2/show/NCT01007942?term=bolero-
3&rank=1. Accessed September 2011.
# # #
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Datum: 26.09.2011 - 00:02 Uhr
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News-ID 69135
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