RECORD-1 trial showed risk reduction of disease progression by 70% in
patients with advanced renal cell carcinoma who have failed on previous
DORVAL, QC, June 2 /CNW Telbec/ - New data presented this weekend at the
44th annual meeting of the American Society of Clinical Oncology (ASCO) in
Chicago show RAD001 (*)(everolimus) may provide an important new treatment
option for patients with advanced renal cell carcinoma (RCC) who have failed
previous targeted therapies.
Study findings from RECORD-1 (REnal Cell cancer treatment with Oral
RAD001 given Daily) confirm RAD001 as the first and only drug to show
significant benefit after failure of approved therapies Sutent(R) or
Nexavar(R),(xx) with the potential to address an unmet medical need. RECORD-1
is an international study of over 400 patients including 10 Canadian research
sites across the country.
"This is the first phase III trial to show clinical benefits in patients
with advanced kidney cancer who have progressed on previous targeted therapies
such as Sutent and Nexavar. The data is particularly encouraging for these
patients as it may offer another treatment option at a time when they still
have the potential to benefit from drug therapy," said Dr. Jennifer Knox,
Medical Oncologist, University Health Network and Assistant-Professor,
Department of Medicine, University of Toronto. "The results show RAD001
extended progression-free survival in patients regardless of the number of
prior treatments, their prognosis status or age. These promising results could
guide kidney cancer specialists in choosing sequential therapy for their
Earlier this year, the RECORD-1 trial was stopped after interim results
showed that patients receiving RAD001 experienced a significant response.
Interim findings of the trial showed that RAD001 more than doubled the time
without tumor growth (from 1.9 to 4 months) after failure of previous targeted
treatment in patients with renal cell carcinoma and reduced the risk of
disease progression by 70% (hazard ratio = 0.30 with 95% CI 0.22 to 0.40;
p-value (less than) 0.0001).
In addition, at the time of analysis, study data showed that 45% of
patients who received RAD001 experienced progression-free survival beyond
"This is tremendous news that has the potential to address an unmet
medical need for many patients who require access to sequential treatment
options for managing metastatic kidney cancer, a malignancy that has
traditionally been one of the most difficult to treat", said Tony Clark,
Chair, Kidney Cancer Canada. "We hope that RAD001 will receive timely approval
and reimbursement status in Canada as it represents an important new treatment
option that will not only extend survival, but will give real hope to kidney
cancer patients and their families."
RAD001 is the first once-daily oral therapy that may offer a new approach
to treating renal cell carcinoma by continuously inhibiting the mTOR protein,
a central regulator of tumor cell division and blood vessel growth in cancer
RECORD-1 is the largest Phase III clinical trial investigating the
effects of an oral mTOR inhibitor in metastatic RCC. It is a randomized,
double-blind placebo-controlled multicenter trial of more than 400 patients
with RCC whose cancer worsened despite prior treatment, including Nexavar(R)
(sorafenib) or Sutent(R) (sunitinib) or both. In addition, prior therapy with
Avastin(R)(xxx) (bevacizumab), interferon, and interleukin-2 was allowed.
The primary endpoint of RECORD-1 was progression-free survival (PFS)
assessed via a blinded, independent central review and defined as the amount
of time between randomization and first documented disease progression or
death due to any cause. Results of the study demonstrated a statistically
significant improvement in PFS for RAD001 compared to placebo (hazard ratio =
0.30 with 95% CI 0.22 to 0.40; p-value (less than) 0.0001; median PFS 4 months
vs. 1.9 months, respectively).
Safety findings in the study were consistent with those seen in prior
Phase II studies. The most frequent adverse events in patients who took RAD001
included mouth sores (40%), feelings of weakness (37%), and rash (25%). There
was a low incidence of grade 3 or 4 drug-related adverse events ((greater
than) 1% of patients listed): mouth sores (3%), lung inflammation (3%),
infection (3%), tiredness/feelings of weakness (4%), diarrhea (1%), mucosal
inflammation (1%), and difficulty breathing (1%). The trial had a low rate of
adverse drug reactions leading to discontinuation among patients who took
About renal cell carcinoma (RCC)
Renal cell carcinoma (RCC) is the most common type of kidney cancer. It
represents 85% of all cases of kidney cancer.
There are several types of RCC, but the most common, called clear cell,
accounts for 80% of diagnoses. In RCC, cancer cells develop in the lining of
the kidney's tubes and grow into a tumor. The two kidneys are found on either
side of the backbone, deep inside the upper part of the abdomen and protected
by the lower ribs. Their job is to filter water, impurities and waste material
from the blood and to produce urine.
Renal cell carcinoma accounts for 2% of all new cancer cases worldwide
with occurrence rates rising steadily around the world.
RAD001 (everolimus), an oral inhibitor of mTOR, is an investigational
drug being studied in multiple tumor types. In cancer cells, RAD001 inhibits
mTOR, a protein that acts as a central regulator of tumor cell division, cell
metabolism, and blood vessel growth. RAD001 is a once-daily oral therapy that
provides continuous inhibition of mTOR.
In addition to renal cell carcinoma, RAD001 is presently being studied in
neuroendocrine tumors, lymphoma, other cancers, and tuberous sclerosis as a
single agent or in combination with existing cancer therapies.
RAD001 is an investigational compound and is currently not approved in
The foregoing release contains forward-looking statements that can be
identified by terminology such as "risk," "potential," "may," "proposed,"
"will," "potential," "look forward," or similar expressions, or by express or
implied discussions regarding potential future regulatory filings or approvals
for RAD001 or regarding potential future revenues from RAD001. 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 RAD001 to be materially different
from any future results, performance or achievements expressed or implied by
such statements. There can be no guarantee that RAD001 will be submitted for
approval, or approved for sale in any market for any oncology indication. Nor
can there be any guarantee that RAD001 will achieve any particular levels of
revenue in the future. In particular, management's expectations regarding
RAD001 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, 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 Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. Novartis Pharmaceuticals
Canada Inc. conducts hundreds of clinical trials across the country seeking
new treatments for cardiovascular disease, oncology, diabetes, cancer,
ophthalmology and organ transplantation. In 2007, the Company invested close
to $86 million in research and development. Novartis Pharmaceuticals Canada
Inc. employs more than 800 people in Canada and its headquarters are located
in Dorval, Québec. In addition to Novartis Pharmaceuticals Canada Inc., the
Novartis Group in Canada consists of Novartis Animal Health Canada Inc.,
Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz
Canada Inc. For further information about Novartis Canada, please consult
Novartis AG 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 www.novartis.com.
(*) RAD001 is an investigational compound and is not currently approved
by Health Canada.
(xx) Sutent is a registered trademark of Pfizer Inc. Nexavar is a
registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
(xxx) Avastin is a registered trademark of Genentech Inc. used under
license by Hoffman-La Roche.
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