Adding Novartis drug Zometa® to chemotherapy significantly improved overall survival in study of newly diagnosed multiple myeloma patients
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* Phase III data show Zometa, a bone-targeted agent, provided significant
clinical anticancer benefit and significantly reduced risk of
skeletal-related events
* Survival advantage observed with Zometa added to chemotherapy versus oral
clodronate added to chemotherapy is independent of skeletal-related event
benefit
* Results from a separate study in premenopausal early breast cancer confirmed
significant anticancer benefit of Zometa in this patient population
* Data add to a growing body of clinical evidence suggesting potential
anticancer activity of Zometa
Basel, June 5, 2010 - New data to be presented tomorrow at the 46th Annual
Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, show
that the addition of Zometa(®) (zoledronic acid) to first-line chemotherapy
significantly improved overall survival for newly diagnosed multiple myeloma
patients by 16% (P=0.0118) and progression-free survival by 12% (P=0.0179)
compared with oral clodronate plus first-line chemotherapy[1]. The 5.5 month
survival improvement demonstrated by Zometa in this study of nearly 2000
patients was independent of the drug's effect on bone complications (also known
as skeletal-related events or SREs)[1]. Zometa was significantly superior to
clodronate in the prevention of SREs associated with multiple myeloma, reducing
the relative risk of SREs 24% more than clodronate (P=0.0004)[1].
Zometa is approved in more than 100 countries for the reduction or delay of bone
complications in multiple myeloma and across a broad range of metastatic cancers
(breast, prostate, lung and other solid tumors) involving bone, as well as for
the treatment of hypercalcemia of malignancy (HCM)[2]. It is the most widely
used bisphosphonate in the oncology setting and has been used to treat more than
3.5 million patients worldwide[3].
"This is the first time we have seen in a large, Phase III independent trial
that the addition of zoledronic acid to chemotherapy significantly improves
survival in patients with multiple myeloma," said Dr. Evangelos Terpos,
Department of Clinical Therapeutics/Oncology Division, University of Athens
School of Medicine, Alexandra General Hospital, Athens, Greece. "These data
suggest that zoledronic acid has the potential to help multiple myeloma patients
live longer."
Other Zometa data presented at ASCO include a five-year follow-up analysis from
the Phase III Austrian Breast & Colorectal Cancer Study Group-12 (ABCSG-12)
trial which showed that the addition of Zometa to hormonal therapy following
surgery improved disease-free survival by 32% (HR=0.68 [95%CI 0.51,0.91],
P=0.009) in premenopausal women with hormone receptor-positive (HR+) early
breast cancer[4]. These data confirm earlier results from ABCSG-12 presented at
ASCO 2008[5]. Data from the ABCSG-12 study are the basis of the Company's US and
European Union regulatory filings for Zometa in the treatment of adjuvant breast
cancer.
"These five-year data are exciting for oncologists and patients alike because
they confirm that adding zoledronic acid to a post-surgical hormonal treatment
regimen can reduce the risk of cancer returning," said Michael Gnant, MD, lead
investigator and Professor of surgery at the Medical University of Vienna. "If
approved for this indication, zoledronic acid may offer early breast cancer
patients the opportunity to further reduce the risk of breast cancer returning,
when added to post-surgery hormone therapy."
Myeloma IX study details[1]
Myeloma IX is a Phase III, prospective, multicenter, randomized, controlled
study to compare intravenous (IV) Zometa (4mg every 3-4 weeks) with oral
clodronate (1600 mg daily) based on the severity of bone disease and in
improving survival. A total of 1,960 evaluable patients from the United Kingdom
with newly diagnosed International Staging System (ISS) Stage I, II or III
multiple myeloma entered either an intensive or non-intensive treatment pathway,
determined on the basis of performance status, informed decision and consent.
Patients were randomized for type of bisphosphonate therapy and first-line
therapy (induction chemotherapy) on a 1:1 basis.
The primary study endpoints were overall survival (OS), progression free
survival (PFS) and response. OS was defined as the length of time after
randomization to death from any cause. PFS was defined as the length of time
from randomization to disease progression or death. Secondary endpoints included
SREs (including bone fractures, radiation to bone, surgery to bone, bone lesions
and/or spinal cord compression) and safety.
At a median follow-up of 3.7 years, risk of death was reduced by 16% (P=0.0118)
and the risk of progression-free survival events fell by 12% (P=0.0179) with
Zometa versus oral clodronate. The proportion of patients who experienced an SRE
was reduced by 24% in those receiving Zometa versus clodronate (27.0% versus
35.3%; P=0.0004). The survival advantage demonstrated by Zometa was observed in
patients with Stage I, II or III newly diagnosed multiple myeloma. This survival
advantage was also observed in addition to and independent of the drug's effect
on SREs.
The tolerability profile of Zometa is well-established and results from this
study were found to be consistent with the known profile. The incidence of
osteonecrosis of the jaw (ONJ) in the Zometa and clodronate treatment arms was
3.6% and 0.3%, respectively. Renal deterioration was reported to be similar
between treatment groups.
ABCSG-12 study details[4],[6]
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 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 62 months.
The primary endpoint for all four study arms was disease-free survival.
Recurrence-free survival, overall survival and bone-mineral density 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. Bone-mineral
density was a primary endpoint of the sub-study. Exploratory endpoints included
bone metastasis-free survival.
At the median follow-up of 62 months, disease-free survival events were reduced
by 32% (P=0.009) with Zometa added to hormone therapy versus hormone therapy
alone. This updated analysis continues to show no difference between tamoxifen
and anastrozole use, but that adding Zometa significantly improves disease-free
survival (HR=0.68 for both arms). Overall, side effects were consistent with
known drug profile. There were no cases of renal failure or confirmed cases of
ONJ in the study.
About Zometa[2]
Zometa is indicated for the prevention of skeletal related events (pathological
fractures, spinal compression, radiation or surgery to bone, or tumor-induced
hypercalcemia) in patients with advanced malignancies involving bone. An
intravenous bisphosphonate, Zometa is the only licensed therapy to demonstrate
efficacy in reducing or delaying bone complications across a broad range of
tumor types such as breast, prostate, lung and renal cell cancers, in patients
with metastatic disease when administered monthly. Zometa is administered as a
4 mg, 15-minute infusion.
Zometa is indicated for the prevention of skeletal-related events (SREs) in
patients with advanced malignancies involving bone across a broad range of
tumors. Laboratory research has 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.
Important Safety Information
Zometa has been associated with reports of renal insufficiency. Patients should
be adequately rehydrated and have their serum creatinine assessed prior to
receiving each dose of Zometa. Due to the risk of clinically significant
deterioration in renal function, single doses of Zometa should not exceed 4 mg
and the duration of infusion should be no less than 15 minutes in 100 ml of
dilutent. Severe and occasionally incapacitating bone, joint, and/or muscle pain
has been reported in patients taking bisphosphonates including Zometa. Caution
is advised when Zometa is used in aspirin-sensitive patients, or with
aminoglycosides, loop diuretics and other potentially nephrotoxic drugs. Zometa
contains the same active ingredient (zoledronic acid) as found in Aclasta.
Patients being treated with Zometa should not be treated with Aclasta
concomitantly.
In clinical trials, the most commonly reported adverse events included flu-like
syndrome (fever, arthralgias, myalgias, and skeletal pain), fatigue,
gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema. Zometa
should not be used during pregnancy. Zometa is contraindicated in patients with
clinically significant hypersensitivity to Zometa or other bisphosphonates, or
any of the excipients in the formulation of Zometa.
Osteonecrosis of the Jaw (ONJ): ONJ has been reported in patients with cancer
receiving treatment including bisphosphonates, chemotherapy, and/or
corticosteroids. The majority of reported cases have been associated with dental
procedures such as tooth extraction. A dental examination with appropriate
preventive dentistry should be considered prior to treatment with
bisphosphonates in patients with concomitant risk factors. While on treatment,
these patients should avoid invasive dental procedures if possible. No data are
available to suggest 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.
For further information please see full Prescribing Information or the summary
of product characteristics.
Novartis is on Twitter at http://twitter.com/novartis. For more information
about the ASCO 2010 Annual Meeting, search for #ASCO10
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "can," "may," or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
for Zometa or regarding potential future revenues from Zometa. 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 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 labeling 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 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; 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,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com
References
[1] Morgan, G. Evaluating the effects of zoledronic acid (ZOL) on overall
survival (OS) in patients (Pts) with multiple myeloma (MM): Results of the
Medical Research Council (MRC) Myeloma IX study. Abstract #8021. American
Society of Clinical Oncology 2010 Annual Meeting.
[2] Zometa(®) (zoledronic acid) European Summary of Characteristics. Novartis
AG. http://www.zometa.com/around-the-world/european-product-characteristics.jsp.
[3] Novartis data on file.
[4] Gnant, M. Mature results from ABCSG-12: Adjuvant ovarian suppression
combined with tamoxifen or anastrozole, alone or in combination with zoledronic
acid, in premenopausal women with endocrine-responsive early breast cancer.
Abstract #533. American Society of Clinical Oncology 2010 Annual Meeting.
[5] Gnant, M. Adjuvant ovarian suppression combined with tamoxifen or
anastrozole, alone or in combination with zoledronic acid, in premenopausal
women with hormone-responsive, stage I and II breast cancer: First efficacy
results from ABCSG-12. Abstract #LBA4. American Society of Clinical Oncology
2008 Annual Meeting.
[6] Gant, M, et al. Endocrine Therapy plus Zoledronic Acid in Premenopausal
Breast Cancer. New Engl J Med. 2009;360;679-91.
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Datum: 05.06.2010 - 14:15 Uhr
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