BASEL--1 Jun--PRNewswire-AsiaNet/InfoQuest
- 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.
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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 #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