Novartis study of Afinitor® in advanced liver cancer does not meet primary endpoint of overall survival
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Novartis study of Afinitor® in advanced liver cancer does not meet primary
endpoint of overall survival
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* Everolimus did not show survival benefit for patients with advanced
hepatocellular carcinoma (HCC) after progression on or intolerance to
sorafinib[1]
* Study results do not impact use of Afinitor in other indications approved by
health authorities around the world
* Novartis continues to study Afinitor in other diseases with high unmet needs
including GI and lung NET, HER2 positive breast cancer, lymphoma and TSC
Basel, August 7, 2013 - Novartis announced today that results of a global Phase
III study showed that Afinitor(®) (everolimus) did not extend overall survival
compared to placebo in patients with locally advanced or metastatic
hepatocellular carcinoma (HCC) after progression on or intolerance to
sorafenib[1]. Hepatocellular carcinoma, an aggressive and debilitating cancer,
is the most common type of liver cancer[2].Novartis will not proceed with
regulatory filings of Afinitor in this indication.
"While we are disappointed with these results, Novartis remains committed to
studying everolimus through a robust research and development program to address
unmet needs in different types of cancer," said Alessandro Riva, Global Head,
Oncology Development & Medical Affairs, Novartis Oncology. "To date, Afinitor
has proven efficacy in a number of tumor types, including hormone receptor
positive advanced breast cancer, advanced pancreatic neuroendocrine tumors and
advanced renal cell carcinoma."
The results of the HCC trial do not impact the worldwide approvals of Afinitor
for these other indications. Everolimus is also in Phase III development in
other diseases, including gastrointestinal and lung neuroendocrine tumors (NET),
HER2 positive breast cancer, lymphoma and tuberous sclerosis complex (TSC).
Results of these trials are expected during 2014 and 2015.
Study details
The Phase III study, EVOLVE-1 (EVerOlimus for LiVer cancer Evaluation-1), is a
randomized, double-blind, placebo-controlled trial examining the efficacy and
safety of everolimus versus placebo, plus best supportive care (BSC), in adult
patients with advanced HCC whose disease progressed after treatment with or who
were intolerant to sorafenib, a targeted therapy[3]. The study results continue
to be evaluated and will be presented at an upcoming medical conference.
EVOLVE-1 involved 546 patients and was conducted at 156 sites worldwide.
Patients in the trial were randomized (2:1) to receive therapy with everolimus
7.5 mg/day orally plus BSC or placebo plus BSC. The primary endpoint was overall
survival. Secondary endpoints included time to tumor progression, disease
control rate,time to deterioration of performance status, safety and quality of
life[1][3].
About everolimus
Afinitor (everolimus) tablets is approved in more than 100 countries, including
the United States and throughout the European Union, in the oncology settings of
advanced renal cell carcinoma following progression on or after vascular
endothelial growth factor (VEGF)-targeted therapy, and in the United States and
European Union for locally advanced, metastatic or unresectable progressive
neuroendocrine tumors of pancreatic origin.
Everolimus is approved as Afinitor in the European Union for the treatment of
hormone receptor-positive, HER2 negative (HR+/HER2 negative) advanced breast
cancer, in combination with exemestane, in postmenopausal women without
symptomatic visceral disease after recurrence or progression following a non-
steroidal aromatase inhibitor. In the United States, Afinitor is approved for
the treatment of postmenopausal women with advanced hormone receptor-positive,
HER2 negative breast cancer (advanced HR+/HER2 negative breast cancer) in
combination with exemestane after failure of treatment with letrozole or
anastrozole.
Everolimus is also available from Novartis for use in certain non-oncology
patient populations under the brand names Afinitor(®) or 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. 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 everolimus tablets
Afinitor/Votubia can cause serious side effects including lung or breathing
problems, infections (including sepsis), and kidney failure, which can lead to
death. Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia
can affect blood cell counts, kidney and liver function, and blood sugar,
cholesterol, and triglyceride levels. Afinitor/Votubia may cause fetal harm in
pregnant women. Highly effective contraception is recommended for women of
child-bearing potential while receiving Afinitor/Votubia and for up to eight
weeks after ending treatment. Women taking Afinitor/Votubia should not breast
feed. Fertility in women and men may be affected by treatment with
Afinitor/Votubia.
The most common adverse drug reactions (incidence >=10 percent) are mouth
ulcers, skin rash, feeling tired or weak, diarrhea, nausea, decreased appetite,
infections (including upper respiratory tract infection), low level of red blood
cells, abnormal taste, inflammation of lung tissue, weight loss, swelling of
extremities or other parts of the body, nose bleeds, itching, vomiting, high
level of blood cholesterol, headache, high level of blood sugar, cough,
spontaneous bleeding or bruising, and breathlessness. The most common Grade 3-4
adverse drug reactions (incidence >=2 percent) are mouth ulcers, feeling tired
or weak, infections, inflammation of lung tissue, diarrhea, spontaneous bleeding
or bruising, low white blood cells (a type of blood cell that fights infection),
and breathlessness. Cases of hepatitis B reactivation, blood clots in the lung
or legs, and menstruation disorders such as absence of periods have been
reported. Abnormalities were observed in hematology and clinical chemistry
laboratory tests.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "continues," "will not," "committed," "expected,"
"continue," "will," "upcoming," 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 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; 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 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Data on file.
[2] Faloppi L. et al. Evolving strategies for the treatment of hepatocellular
carcinoma: from clinical-guided to molecularly-tailored therapeutic options.
Cancer Treat Rev. 2011; 37(3):169-77.
[3] US National Institutes of Health. Global Study Looking at the Combination of
RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients
With Advanced Hepatocellular Carcinoma (EVOLVE-1). Available at
http://clinicaltrials.gov/ct2/show/NCT01035229?term=EVOLVE-1&rank=1. Accessed
August 2013.
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Datum: 07.08.2013 - 07:16 Uhr
Sprache: Deutsch
News-ID 285322
Anzahl Zeichen: 13557
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