- Zometa when added to hormone therapy, following surgery, significantly
reduced the risk of cancer returning or death by 36% beyond clinical
benefits achieved with hormone therapy alone(1)
- Findings may allow clinicians to improve standard of care for
premenopausal women diagnosed with hormone-sensitive, early-stage breast
cancer
- These are the first data from a large clinical program exploring the
direct anticancer effect of Zometa in breast, lung and prostate cancer
EAST HANOVER, N.J., May 31 /PRNewswire/ -- New data presented today
showed that Zometa(R) (zoledronic acid) offered a significant anticancer
benefit for premenopausal women with hormone-sensitive, early-stage breast
cancer. The study found that Zometa when added to hormone therapy,
following surgery, significantly reduced the risk of cancer returning or
death by 36% beyond clinical benefits achieved with hormone therapy alone.
To view the Multimedia News Release, go to:
http://www.prnewswire.com/mnr/novartis/33472/
Investigators from the Austrian Breast & Colorectal Cancer Study Group
(ABCSG) announced the findings during a plenary presentation today at the
44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, Illinois, USA.
"This study is the first large-scale trial to demonstrate the
significant antitumor benefit of zoledronic acid," said lead investigator
Michael Gnant, M.D., of the Medical University of Vienna. "These new
findings may allow oncologists to further improve the standard of care for
premenopausal women with hormone-sensitive breast cancer."
According to the World Health Organization (WHO), each year
approximately 500,000 women die worldwide because their breast cancer has
returned or spread(2). Moreover, the incidence of breast cancer has been
rising in recent decades(3).
"These results represent a tremendous advance for women hoping to
prevent the return of their cancer," said David Epstein, President and CEO
of Novartis Oncology. "We continue to explore the anticancer benefit of
Zometa in a large clinical program with nearly 20,000 patients in 10 trials
worldwide. We anticipate additional results over the next two to three
years."
The ABCSG-12 study, in which women were treated for three years and
observed for an additional two years, demonstrated that the addition of
Zometa to hormone therapy (tamoxifen or anastrozole) significantly
prolonged both disease-free survival and recurrence-free survival. With
Zometa, the risk of disease-free survival events (which include death from
any cause) fell by 36% (P=0.01), compared to hormone therapy alone.
Furthermore, the risk of recurrence-free survival events fell by 35%
(P=0.015) with Zometa, compared to hormone therapy alone. A positive but
non-significant trend toward an overall survival benefit was also seen in
patients who received Zometa(1).
Zometa is the world's leading treatment for the prevention or delay of
skeletal-related events (SREs) in patients with advanced malignancies
involving bone across a broad range of tumors. Laboratory research had
suggested that Zometa may also help protect patients from the spread of
cancer to other parts of the body (distant metastatic sites) and help keep
patients recurrence-free.
Zometa slows the bone-destroying effect that occurs with bone
metastases by fighting abnormal activation of osteoclasts, cells that
normally break down old bone, and osteoblasts, cells that normally build
new bone. Growth factors produced by cancer cells overstimulate osteoclasts
and osteoblasts, causing excessive erosion of bone and/or the abnormal
buildup of new but unstable bone.
Laboratory research has suggested that Zometa may also have anticancer
effects, including helping to protect against the return and spread of
cancer before it reaches an advanced stage. A tumor passes through six
stages on its path to metastasizing (spreading)(4). In the laboratory,
Zometa has been shown to make passage through these stages more difficult
by inhibiting angiogenesis (formation of blood vessels that grow and feed
cancer cells), stimulating cancer-fighting T-cells, inducing tumor cell
apoptosis (programmed cell death) and increasing the activity of anticancer
agents that target tumor cell metastases(5).
A growing number of clinical studies are examining the potential
anticancer impact of Zometa. One of the largest of these studies, AZURE
(Adjuvant Zoledronic acid to redUce REcurrence), has completed enrollment.
The study will evaluate the impact of Zometa in reducing risk of cancer
recurrence in 3,360 premenopausal and postmenopausal women with Stage
II/III breast cancer.
Another study presented at this year's ASCO meeting evaluated the
effect of Zometa on bone marrow micrometastases. The study was conducted in
120 premenopausal and postmenopausal women with Stage II/III breast cancer
undergoing treatment pre- and post-surgery. For those women who were
negative for disseminated cancer cells at baseline, significantly more
women who took Zometa in addition to chemotherapy remained negative for
disseminated cancer cells over time.
Study Details
The Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12)
is an open-label, multicenter, Phase III study that enrolled 1,803
premenopausal women with estrogen-receptor-positive Stage I or II breast
cancer, with fewer than 10 axillary lymph nodes involved. Patients were
recruited for the study after curative surgery and initiation of goserelin
treatment for ovarian suppression, and randomly assigned into one of four
study groups: (1) anastrozole plus Zometa; (2) anastrozole alone; (3)
tamoxifen plus Zometa; (4) tamoxifen alone. The treatment period was three
years and the median follow-up period was an additional two years(1).
The primary endpoint of the study was disease-free survival for all
four study groups. Recurrence-free survival, overall survival, and safety
were secondary endpoints. (Disease-free survival was defined as the length
of time after randomization during which patients had no local recurrence,
contralateral breast cancer, distant metastasis, secondary carcinoma,
and/or death from any cause. Recurrence-free survival was defined as the
length of time after randomization during which patients had no local
recurrence, contralateral breast cancer, distant metastasis, and/or
secondary carcinoma.) Exploratory endpoints included bone-metastases-free
survival(1).
At the median follow-up of five years, disease-free survival events
were reduced by 36% (P=0.01) with Zometa and the risk of recurrence-free
survival events fell by 35% (P=0.015) versus hormone therapy alone. Sixteen
deaths had occurred among patients who received Zometa with hormone therapy
versus 26 deaths in patients who received hormone therapy alone, which
resulted in a nonsignificant reduction in the risk of death in patients who
received Zometa compared with those who received hormone therapy alone
(P=0.103). A similar trend was noted toward a reduction in bone metastases
among patients who received Zometa compared with those who received hormone
therapy alone (16 versus 23). Longer follow-up and a larger number of
events will be necessary to determine if any significant differences exist
between the groups for overall survival and bone-metastases-free survival.
Overall, treatment was generally well-tolerated and side effects were
consistent with known drug safety profile(1).
About Zometa
Zometa is indicated for patients with multiple myeloma and documented
bone metastases from solid tumors in conjunction with standard
antineoplastic therapy; prostate cancer should have progressed after
treatment with at least one hormonal therapy.
Important Safety Information
Zometa is contraindicated in patients with hypersensitivity to
zoledronic acid or other bisphosphonates, or any of the excipients in the
formulation of Zometa. Hypersensitivity reactions, including rare cases of
urticaria and angioedema and very rare cases of anaphylactic
reaction/shock, have been reported.
Due to the risk of clinically significant deterioration in renal
function, which may progress to renal failure, single doses of Zometa
should not exceed 4 mg, and the duration of infusion should be no less than
15 minutes. Risk factors for the deterioration of renal function include
impaired baseline renal function and multiple cycles of bisphosphonate
treatment.
Zometa is not recommended in patients with bone metastases with severe
renal impairment. In patients with mild to moderate renal impairment at
baseline, lower doses of Zometa are recommended based on calculated
creatinine clearance. Before each Zometa dose, serum creatinine should be
measured and treatment should be withheld for renal deterioration until
serum creatinine has returned to within 10% of the baseline value.
Zometa should not be used during pregnancy. Women of childbearing
potential should be advised to avoid becoming pregnant. If the patient
becomes pregnant while taking this drug, the patient should be apprised of
the potential harm to the fetus.
Osteonecrosis of the jaw (ONJ) has been reported predominantly in
cancer patients treated with intravenous bisphosphonates, including Zometa.
Many of these patients were also receiving chemotherapy and
corticosteroids, which may be risk factors for ONJ. Postmarketing
experience and the literature suggest a greater frequency of reports of ONJ
based on tumor type (advanced breast cancer, multiple myeloma) and dental
status (dental extraction, periodontal disease, local trauma, including
poorly fitting dentures). Many reports of ONJ involved patients with signs
of local infection, including osteomyelitis. Cancer patients should
maintain good oral hygiene and should have a dental examination with
preventive dentistry prior to treatment with bisphosphonates. While on
treatment, these patients should avoid invasive dental procedures, if
possible. No data are available as to whether discontinuation of
bisphosphonate therapy reduces the risk of ONJ in patients requiring dental
procedures. A causal relationship between bisphosphonate use and ONJ has
not been established. Clinical judgment of the treating physician should
guide the management plan of each patient based on individual benefit/risk
assessment.
In postmarketing experience, severe and occasionally incapacitating
bone, joint, and/or muscle pain has been reported infrequently in patients
taking bisphosphonates.
The most common adverse events (greater than or equal to 15%) in bone
metastases clinical trials, regardless of causality, with Zometa 4 mg
(n=1031) were as follows: bone pain (55%), nausea (46%), fatigue (39%),
anemia (33%), pyrexia (32%), vomiting (32%), constipation (31%), dyspnea
(27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough
(22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm
aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%),
insomnia (16%), decreased weight (16%), back pain (15%), and paresthesia
(15%).
Caution is advised when bisphosphonates are administered with
aminoglycosides, loop diuretics, and potentially nephrotoxic drugs.
Zometa contains the same active ingredient as found in Reclast(R)
(zoledronic acid). Patients being treated with Zometa should not be treated
with Reclast.
Patients should be administered an oral calcium supplement of 500 mg
and a multiple vitamin containing 400 IU of vitamin D daily.
Please see full Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "may", "continue to", "anticipate",
"potential", "will", or similar expressions, or by express or implied
discussions regarding potential new indications or labelling for Zometa or
regarding potential future revenues from Zometa. Such forward-looking
statements reflect the current views of the Company regarding future
events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with Zometa to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that Zometa will be
submitted or approved for any additional indications or labelling in any
market. Nor can there be any guarantee that Zometa will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding Zometa 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, 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 Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological, GI
and respiratory areas. The company's mission is to improve people's lives
by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS), which provides
healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines and diagnostic
tools, and consumer health products. Novartis is the only company with
leading positions in these areas. In 2007, the Group's continuing
operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion
was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 98,200
full-time associates and operate in over 140 countries around the world.
For more information, please visit http://www.novartis.com.
For more information
Additional information regarding Zometa and Novartis Oncology can be
found on the websites http://www.novartisoncologyvpo.com,
http://www.zometa.com and http://www.novartisoncology.com.
References
1. Gnant, M. et al. Efficacy of Zoledronic Acid in Premenopausal Women
With Breast Cancer Receiving Adjuvant Endocrine Therapy - The ABCSG-12
trial. Presented at: the 44th Annual Meeting of the American Society of
Clinical Oncology (ASCO) in Chicago, Ill., 31 May - 2 June, 2008;
Abstract LBA4.
2. World Health Organization.
http://www.who.int/mediacentre/factsheets/fs297/en/index.html
3. Breastcancer.org:
http://www.breastcancer.org/about_us/press_room/press_kit/cancer_facts.jsp
4. Mundy, GR, et al. Metastases to bone: causes, consequences and
therapeutic opportunities. Nature Reviews Cancer. 2002; 2:584-593.
5. Aft, R, et al. ABSTRACT 1021: Effect of zoledronic acid on bone marrow
micrometastases in women undergoing neoadjuvant chemotherapy for breast
cancer.
Contact Information
Media Only:
Megan Humphrey
Novartis Oncology
1-862-778-6725
megan.humphrey@novartis.com
Dana Kahn Cooper
1 -732-239-6664
Investors Only:
Jill Pozarek
Novartis Corporation
1-212-830-2445
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