Novartis drug Afinitor® extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumors
(Thomson Reuters ONE) -
Novartis International AG /
Novartis drug Afinitor® extended progression-free survival in Phase III trial in
advanced gastrointestinal or lung neuroendocrine tumors
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* Study in patients with advanced nonfunctional neuroendocrine tumors (NET) of
gastrointestinal (GI) or lung origin met primary endpoint[1]
* Full results will be submitted for presentation at a major medical meeting;
worldwide regulatory filings are planned for 2015
* Afinitor is already approved in more than 95 countries for patients with
advanced pancreatic NET, a rare form of cancer[1],[2],[3]
Basel, May 21, 2015 - Novartis announced today that the Phase III study of
Afinitor(®) (everolimus) tablets plus best supportive care in patients with
advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or
lung origin met its primary endpoint: significant extension of progression-free
survival (PFS) compared to placebo plus best supportive care[1]. The RADIANT-4
study is part of one of the largest clinical trial programs in NET[1].
NET are a rare type of cancer that originate in neuroendocrine cells found
throughout the body, and are most often found in the GI tract, lungs or
pancreas[4]. NET can be functional or nonfunctional: functional NET produce
symptoms caused by the secretion of hormones and other substances; nonfunctional
NET do not secrete hormones, and may only produce symptoms caused by the tumor's
growth, such as intestinal blockage, pain and bleeding[5],[6],[7]. At time of
diagnosis, up to 44% of patients with GI NET and 28% of patients with lung NET
have advanced disease, meaning the cancer has spread to other parts of the body
and is more difficult to treat[2],[3],[4]. There are limited treatment options
for patients with advanced GI or lung NET[4].
"We look forward to presenting the findings from the RADIANT-4 trial of
everolimus, which has the potential to become an important treatment option for
patients with advanced nonfunctional GI or lung NET," said Alessandro Riva, MD,
Global Head, Novartis Oncology Development and Medical Affairs. "The results
will serve as the basis of planned worldwide regulatory filings for everolimus
in these two types of NET, bringing us closer to our goal of offering Afinitor
for these patients."
Full results from the RADIANT-4 study will be submitted to a major medical
meeting. Worldwide regulatory filings are planned for 2015.
About RADIANT-4
RADIANT-4 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 302 patients with well differentiated advanced NET of GI or
lung origin, and no history or active symptoms of carcinoid syndrome, who had
documented disease progression within the previous 6 months. Patients were
randomized 2:1 to receive either daily everolimus 10 mg or daily placebo orally.
The primary endpoint of RADIANT-4 was PFS. Secondary endpoints included safety,
objective response rate and overall survival.
About Afinitor(®) (everolimus) tablets
Afinitor(®) (everolimus) is approved in more than 95 countries, including the
United States and throughout the European Union, for locally advanced,
metastatic or unresectable progressive neuroendocrine tumors of pancreatic
origin. It is also approved in 119 countries including the United States and
European Union for advanced renal cell carcinoma following progression on or
after vascular endothelial growth factor (VEGF)-targeted therapy.
Afinitor is approved in the European Union for the treatment of hormone
receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-)
advanced breast cancer, in combination with exemestane, in postmenopausal women
without symptomatic visceral disease after recurrence or progression following a
non-steroidal aromatase inhibitor (NSAI). In the United States, Afinitor is
approved for the treatment of postmenopausal women with advanced hormone
receptor-positive, HER2 negative (advanced HR+/HER2-) 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 Afinitor(®) (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. Patients taking concomitant angiotensin-converting enzyme (ACE)
inhibitors may be at an increased risk for angioedema. 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, absence of menstrual
periods, infections (including upper respiratory tract infection, sore throat
and runny nose, sinusitis, and pneumonia), nausea, decreased appetite, low level
of red blood cells, high levels of cholesterol, abnormal taste, acne, irregular
menstrual periods, inflammation of lung tissue, high level of blood sugar,
weight loss, itching, swelling of extremities or other parts of the body, nose
bleeds, and headache. The most common Grade 3-4 adverse drug reactions
(incidence >=2 percent) are mouth ulcers, absence of menstrual periods, low
level of red blood cells, infections (including pneumonia), high level of blood
sugar, feeling tired or weak, low white blood cells, inflammation of lung
tissue, diarrhea, and spontaneous bleeding or bruising. Cases of hepatitis B
reactivation, blood clots in the lung or legs, and pneumocystis jirovecii
pneumonia (PJP) 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 words such as "will," "planned," "can," "look forward," "potential," "goal,"
"plan," "yet," or similar terms, 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 are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that Afinitor will be
submitted or approved for any additional indications or labeling in any market,
or at any particular time. Nor can there be any guarantee that Afinitor will be
commercially successful in the future. In particular, management's expectations
regarding Afinitor could be affected by, among other things, the uncertainties
inherent in research and development, including unexpected clinical trial
results and additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; the company's ability to
obtain or maintain proprietary intellectual property protection; general
economic and industry conditions; global trends toward health care cost
containment, including ongoing pricing pressures; unexpected manufacturing
issues, and other risks and factors referred to in Novartis AG's current Form
20-F on file with the US Securities and Exchange Commission. 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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
full-time-equivalent associates. Novartis products are available in more than
180 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] Novartis data on file.
[2] National Library of Medicine and the National Institutes of Health.
Pancreatic islet cell tumor. Available at
http://www.nlm.nih.gov/medlineplus/ency/article/000393.htm. Accessed May 2015.
[3] Halfdanarson, et al. Pancreatic neuroendocrine tumors (PNETs): incidence,
prognosis and recent trend toward improved survival. Annals of Onc.
2008; 19: 1727-1733.
[4] Yao, et al. One Hundred Years After "Carcinoid:" Epidemiology of and
Prognostic Factors for Neuroendocrine Tumors in 35,825 Cases in the United
States. J Clin Oncol. 2008; 26: 3063-72.
[5] Akerstrom, et al. Timing and extent of surgery in symptomatic and
asymptomatic neuroendocrine tumors of the pancreas in MEN 1. Langenbecks Arch
Surg. 2002; 386:558-69.
[6] Modlin, et al. Priorities for Improving the Management of
Gasteroenteropancreatic Neuroendocrine Tumors. J Natl Cancer Inst
2008;100: 1282-1289.
[7] Oberg K, Kvols L, Caplin M, et al. Consensus report on the use of
somatostatin analogs for the management of neuroendocrine tumors of the
gastroenteropancreatic system. Ann Oncol. 2004: 966-976.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Karen Hamel
Novartis Global Media Relations Novartis Oncology
+41 61 324 7999 (direct) +1 862 778 2836 (direct)
+41 79 593 4202 (mobile) +1 862 210 5328 (mobile)
eric.althoff(at)novartis.com karen.hamel(at)novartis.com
e-mail: media.relations(at)novartis.com
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please contact:
journalisthelp(at)thenewsmarket.com.
Novartis Investor Relations
Central phone: +41 61 324 7944
Samir Shah +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Richard Pulik +1 212 830 2448
Thomas Hungerbuehler +41 61 324 8425 Sloan Pavsner +1 212 830 2417
Isabella Zinck +41 61 324 7188
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/1923072/689591.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novartis International AG via GlobeNewswire
[HUG#1923072]
Unternehmensinformation / Kurzprofil:
Datum: 21.05.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 394885
Anzahl Zeichen: 14478
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 258 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis drug Afinitor® extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumors"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
