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- Phase III ATLAS Study Achieves a New Milestone in Treating Advanced
BASEL, Switzerland, May 30 /CNW/ - Roche announced today that the Phase
III ATLAS study showed patients with advanced non-small cell lung cancer
(NSCLC) who received Avastin(R) (bevacizumab) and Tarceva(R) (erlotinib) as
combined first-line maintenance treatment had a 39 percent improvement in the
time they lived without the disease advancing (progression-free survival or
PFS, the primary endpoint of the study), compared with those who received
Avastin alone(1). The ATLAS study was stopped early because of the superior
efficacy for patients in the combined treatment group.
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Avastin-based therapy is already proven to offer patients with advanced
NSCLC over 12 months survival - the longest survival time ever
demonstrated(2),(3). Now results from the ATLAS study show that after initial
treatment with Avastin and chemotherapy, combined maintenance treatment with
Avastin and Tarceva extends the time patients live without their disease
getting worse to 4.8 months compared to 3.7 months with Avastin maintenance
therapy alone. Advanced NSCLC progresses rapidly and this benefit represents a
new milestone in the treatment of the disease. Importantly, this improvement
was achieved without the need for continued chemotherapy.
The value of Tarceva for maintenance treatment in advanced NSCLC was
confirmed in a second Phase III study - SATURN(4), also presented today at
ASCO. Patients in the SATURN trial received maintenance treatment with Tarceva
if their cancer had not progressed on initial chemotherapy. The data showed a
significant 41% improvement in the length of time patients lived without their
disease getting worse compared to placebo. The improvement was seen in both
squamous cell and non-squamous cell lung cancer patients.
Commenting on the two studies Professor Federico Cappuzzo, principal
investigator on the SATURN study from the Istituto Clinico Humanitas IRCCS,
Milan said, "ATLAS and SATURN bring welcome news for patients and their
physicians since extending the time patients live without their disease
advancing is a key goal of treatment in lung cancer. Stopping the cancer
growing for as long possible reduces symptoms and helps improve the patient's
life. Being able to achieve these benefits without the need for chemotherapy
is important since the side effects of chemotherapy add considerably to the
physical and psychological burden of cancer for many patients."
Lung cancer is the most common cancer worldwide with 1.5 million new
cases annually(5) and NSCLC accounts for almost 85 percent of all lung
cancers(6). NSCLC progresses rapidly. Less than 5% of advanced NSCLC patients
survive for five years(6). Extending the time patients live without their
disease progressing and managing side effects are key treatment goals. Each
day, more than 3,000 people die from lung cancer worldwide(5).
Results of the ATLAS study were featured today during a press briefing at
the 45th annual meeting of the American Society of Clinical Oncology (ASCO).
Full results will be presented tomorrow by Dr. Vincent A. Miller, M.D., lead
investigator of the ATLAS study, and Associate Attending Physician, Memorial
Sloan-Kettering Cancer Center (Abstract No.LBA8002 - Sunday, May 31, 2009,
9:30 a.m. - 9:45 a.m. EST, West Hall E1). Full results of SATURN will also be
presented tomorrow (Abstract No.8001 - Sunday, May 31, 2009, 9:15 a.m. - 9:30
a.m. EST, West Hall E1).
Study background and key results
A global multicentre, randomised, double blind, placebo controlled study
that enrolled 1,160 patients with locally advanced, recurrent or metastatic
NSCLC. Patients were initially given first line treatment of four cycles of
Avastin in combination with investigators' choice of multiple platinum-based
chemotherapy regimens. If their cancer did not progress patients were then
randomised (n=743 ITT) to receive maintenance therapy with Avastin in
combination with Tarceva or Avastin plus placebo, until disease progression.
- The ATLAS study met its primary endpoint with a statistically
significant extension in the time patients live without their disease
worsening; 39% improvement compared to those who received maintenance therapy
with Avastin alone. Median progression free survival (PFS) was 4.8 months for
the combination compared to 3.7 months for Avastin maintenance therapy alone
with a highly significant hazard ratio of 0.722 (p-value=0.0012).
A global multicentre, double blind, randomised, prospective phase III
study to evaluate the efficacy of Tarceva or placebo in patients with
advanced, recurrent or metastatic NSCLC who had not progressed following first
line platinum based chemotherapy. The study involved more than 880 patients
from approximately 160 centres; 438 received Tarceva and 451 placebo.
- The study met its primary endpoint demonstrating a statistically
significant extension of the time patients live without their disease
worsening; there was a 41% increase compared with placebo (hazard ratio= 0.71.
p-value (less than)0.0001).
Adverse events in both the ATLAS and SATURN studies were consistent with
previous Avastin or Tarceva studies, as well as with trials evaluating the two
medicines together, and no new safety signals were observed.
Avastin is an antibody that specifically binds and blocks VEGF (vascular
endothelial growth factor). VEGF is the key driver of tumour angiogenesis - an
essential process of development and maintenance of blood vessels which is
required for a tumour to grow and to spread (metastasize) to other parts of
the body. Avastin's precise mode of action helps control tumour growth and
metastases with only a limited impact on side effects of chemotherapy.
Avastin has proven survival benefits across multiple tumour types.
Avastin is approved in Europe for the treatment of the advanced stages of four
common types of cancer: colorectal cancer, breast cancer, lung cancer and
kidney cancer. These types of cancer collectively cause nearly 3 million
deaths each year. In the US, Avastin was the first anti-angiogenesis therapy
approved by the FDA and is now approved for the treatment of four tumour
types: breast, colorectal, glioblastoma, and non-small cell lung cancer
More than 500,000 patients have been treated with Avastin so far. A
comprehensive clinical programme with more than 450 clinical trials is
investigating the use of Avastin in various tumour types (including
colorectal, breast, lung, brain, gastric, ovarian, prostate and other cancers)
and different settings (advanced or early stage disease).
Tarceva is different from conventional chemotherapies and has been shown
to potently inhibit EGFR. It is the first and only EGFR oral targeted agent in
second line with a proven and significant survival and symptom benefit in a
broad range of patients with advanced lung cancer without the side effects
associated with chemotherapy. Tarceva has been approved in the EU since
September 2005 and in the US since November 2004 for the treatment of patients
with locally advanced or metastatic NSCLC after failure of at least one prior
Furthermore, Tarceva in combination with chemotherapy is the first
treatment in over a decade to have shown a significant survival benefit in
treating patients with pancreatic cancer. It is approved in the US in
combination with gemcitabine for the first line treatment of patients with
locally advanced, unresectable or metastatic pancreatic cancer and in the EU
for treatment of metastatic pancreatic cancer. Since its initial launch three
years ago, Tarceva has been used to treat more than 250,000 patients and has
been approved in over 80 countries worldwide.
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(1) Miller V et al. Abstract LBA8002 presented at ASCO 2009 Annual
Meeting, Orlando, US.
(2) Sandler A, et al. N Engl J Med. 2006:355; 2542-50.
(3) Sandler AB et al. J Thor Oncol 2008; 3 (1) Supplement 4, S283.
(4) Cappuzzo F et al. Abstract 8001 presented at ASCO 2009 Annual
Meeting, Orlando, US.
(5) Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American
Cancer Society, 2007.
(6) Allen J et al. J Natl Compr Canc Netw 2008; 6(3): 285-93.
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