Novartis drug Afinitor® met primary endpoint of Phase III study in women with advanced breast cancer; potential to address significant unmet need
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Novartis International AG /
Novartis drug Afinitor® met primary endpoint of Phase III study in women with
advanced breast cancer; potential to address significant unmet need
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* Trial stopped early after positive interim results showed everolimus plus
exemestane extended time without tumor growth
* Postmenopausal ER+HER2- metastatic breast cancer patients whose disease has
progressed despite initial endocrine therapy need effective new
treatments[1]
* Full study results to be submitted for presentation at an upcoming medical
congress and worldwide regulatory filings are planned by the end of 2011
Basel, July 05, 2011 - Novartis announced today that an interim analysis of a
pivotal Phase III study showed Afinitor(®) (everolimus) tablets in combination
with exemestane significantly extended progression-free survival (PFS), or time
without tumor growth, when compared to placebo plus exemestane in women with
advanced breast cancer. The trial was stopped early after interim results showed
the primary endpoint of PFS was met. The study included postmenopausal women
with ER+HER2- metastatic breast cancer whose disease has progressed, despite
initial endocrine therapy.
"Despite clinical progress in advanced breast cancer, most women are either
initially resistant or develop resistance to endocrine therapy over time. As a
result, there is a significant need for new treatment options," said Hervé
Hoppenot, President, Novartis Oncology. "Based on these study results, this
combination has the potential to extend the time until chemotherapy is needed
for these patients."
The study, BOLERO-2 (Breast cancer trials of OraL EveROlimus-2), is a Phase III,
randomized, double-blind, placebo-controlled study of everolimus in combination
with exemestane versus placebo plus exemestane in postmenopausal women with
estrogen receptor-positive locally-advanced or metastatic breast cancer, whose
disease has progressed, despite treatment with the nonsteroidal aromatase
inhibitors letrozole or anastrozole[2].
Results will be presented at an upcoming medical conference and worldwide
regulatory submissions are being planned by the end of 2011.
Everolimus targets mTOR in cancer cells, a protein that acts as an important
regulator of tumor cell division, blood vessel growth and cell metabolism.
Everolimus is also being investigated for the treatment of patients with HER2+
advanced breast cancer[3].
Study design
BOLERO-2 involved more than 700 patients at over 195 sites worldwide[2,4].
Patients in the trial were randomized (2:1) to receive continuous therapy with
everolimus 10 mg/day orally or placebo plus oral exemestane 25 mg/day. Patients
who had received more than one prior chemotherapy regimen for advanced breast
cancer were excluded from enrollment. The primary endpoint was progression free
survival. Secondary endpoints included overall survival, overall response rate,
incidence of adverse events, patient reported outcomes and clinical benefit
rate[2].
About everolimus
Afinitor(®) (everolimus) tablets is approved in the European Union (EU) 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 and also in the US and in Switzerland for the treatment of
patients with advanced RCC after failure of treatment with sunitinib or
sorafenib.
In Switzerland, everolimus is approved with the trade name Votubia(®)
(everolimus) tablets for the treatment of patients three years of age and older
with subependymal giant cell astrocytoma (SEGA) associated with tuberous
sclerosis (TS) for whom surgery is not a suitable option. Should everolimus be
approved in the EU, the trade name will be Votubia. In the US, Afinitor is
approved to treat patients with SEGA associated with TS who require therapeutic
intervention but are not candidates for curative surgical resection. The
effectiveness of everolimus is based on an analysis of change in SEGA volume.
Clinical benefit such as improvement in disease-related symptoms or increase in
overall survival has not been shown.
Afinitor is also approved in the US for the treatment of progressive
neuroendocrine tumors of pancreatic origin in patients with unresectable,
locally advanced or metastatic disease. The US Food and Drug Administration
determined that the safety and effectiveness of Afinitor in the treatment of
patients with carcinoid tumors have not been established. Novartis has submitted
a marketing application for everolimus to the European Medicines Agency for this
use, and similar regulatory submissions are under way worldwide.
In the EU, everolimus is available in different dosage strengths for the non-
oncology patient population 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 prophylaxis of organ rejection in adult patients at low-
moderate immunologic risk receiving a kidney transplant.
Everolimus is exclusively licensed to Abbott and sublicensed to Boston
Scientific for use in drug-eluting stents.
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. Because of the uncertainty of clinical trials, there is no
guarantee that everolimus will become commercially available for breast cancer
anywhere in the world. The efficacy and safety of everolimus in breast cancer
has not been established.
Important Safety Information about Afinitor
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 have been
reported.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "to be submitted," "planned," "will," "potential," or
similar expressions, or by express or implied discussions regarding potential
submissions or approvals for new indications or labeling for Afinitor, or
regarding the potential timing of any such submissions or approvals, 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; government, industry and general public pricing pressures;
competition in general; 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.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Miles, David. When HER2 is not the target: advances in the treatment of
HER2-negative metastatic breast cancer. Breast Cancer Research 2009 August;
11(4).
[2] US National Institutes of Health Everolimus in Combination With Exemestane
in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally
Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or
Anastrozole (BOLERO-2). Available
athttp://clinicaltrials.gov/ct2/show/NCT00863655. Accessed June 2011.
[3] Motzer, et. al. Phase 3 Trial of Everolimus for Metastatic Renal Cell
Carcinoma. Cancer 2010 Sep; 116(18):4256-4265.
[4] Data on file.
# # #
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Datum: 05.07.2011 - 07:15 Uhr
Sprache: Deutsch
News-ID 56120
Anzahl Zeichen: 14140
contact information:
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