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Maintenance Treatment With Avastin and Tarceva in Combination Helps Lung Cancer Patients Live Longer Without Their Disease Worsening

Basel, Switzerland (ots/PRNewswire)

  • For ex-US Media Only
  • Phase III ATLAS Study Achieves a New Milestone in Treating Advanced Lung Cancer
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.
To view the Multimedia News Release, please click:
http://www.prnewswire.com/mnr/roche/38591/
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 #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 #8001 - Sunday, May 31, 2009, 9:15 a.m.
- 9:30 a.m. EST, West Hall E1).
Study background and key results
ATLAS
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).
SATURN
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 <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.
About Avastin
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 (NSCLC).
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).
About Tarceva
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 chemotherapy regimen.
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.
About Roche
Information about the Roche Group is available on the Internet at
http://www.roche.com
All trademarks used or mentioned in this release are protected by
law.
References
[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.

Contact:

For further information please contact: Roche Group Media Relations,
Phone: +41-61-688-8888 / e-mail: basel.mediaoffice@roche.com - Daniel
Piller (Head), - Alexander Klauser, - Martina Rupp, - Claudia
Schmitt, - Nina Schwab-Hautzinger; Anna Gray, Galliard, Tel Direct:
+44-(0)20-7663-2271, Mobile: +44-(0)7590-711189, email:
agray@galliardhealth.com

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