Saturday, May 30, 2009

<AsiaNet> Maintenance Treatment With Avastin and Tarceva in Combination Helps





Lung Cancer Patients Live Longer Without Their Disease Worsening

(BASEL, May 31 AsiaNet= 연합뉴스)

- 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.

SOURCE: Roche

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