Investor Update
Basel, 30 May 2009
Phase III study showed patients lived longer without advanced lung cancer progressing when Tarceva was added to Avastin as first-line maintenance therapy
Roche today announced that a Phase III study (ATLAS) showed patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva® (erlotinib) in combination with Avastin® (bevacizumab) as first-line maintenance treatment had a 39 percent improvement in the time they lived without the disease advancing (progression-free survival or PFS), compared with those who received Avastin plus placebo (hazard ratio=0.72; p=0.0012). Adverse events were consistent with previous Avastin or Tarceva NSCLC studies, or trials evaluating the two medicines together.
Most people with lung cancer are diagnosed with advanced stage disease that cannot be surgically removed or has spread to other parts of the body. The majority of people with advanced lung cancer survive less than one year.
“A second round of treatment following cancer progression is not an option for many patients with advanced NSCLC,” said Vincent A. Miller, M.D., lead investigator of the ATLAS study, and Associate Attending Physician, Memorial Sloan-Kettering Cancer Center. “ATLAS showed that Avastin and Tarceva, when combined in the first-line maintenance setting, helped delay the growth or spread of the cancer.”
“With this study we continue to build on the important advances Avastin has made in the first-line treatment of lung cancer,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “It is our hope that adding the daily pill Tarceva to Avastin in the maintenance setting may potentially expand the options available for patients with advanced NSCLC who receive Avastin as an initial therapy.”
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. Miller (Abstract #LBA8002 – Sunday, May 31, 2009, 9:30 a.m. – 9:45 a.m. EST, West Hall E1).
ATLAS is the second positive study that showed Tarceva in the first-line maintenance setting improved PFS. Another study, SATURN, showed patients who received Tarceva alone as a maintenance treatment following initial chemotherapy had a significant improvement in PFS, compared with placebo. 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).
About ATLAS (AVF3671g)
ATLAS was a global, multicenter, randomized, double-blind, placebo-controlled study. Patients in the study were treated with Avastin plus four cycles of platinum-based chemotherapy. If the cancer did not progress and patients did not experience significant toxicity, patients (n=743) were then randomized to receive Avastin plus either Tarceva or placebo until progression. PFS, as assessed by investigators, was defined as the length of time from randomization to disease progression or death from any cause.
The 39 percent improvement in PFS observed in the study can also be referred to as a 28 percent reduction in the risk of cancer progression or death (hazard ratio=0.72; p=0.0012). Median PFS following four initial cycles of Avastin and chemotherapy was 4.8 months for patients who received the combination and 3.7 months for those who received Avastin plus placebo. Secondary endpoints included safety and overall survival. Overall survival data are expected in the second half of 2009.
Safety and Adverse events
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 Lung Cancer
Lung cancer is the most common cancer worldwide with 1.5 million new cases annually1 and NSCLC accounts for almost 85 percent of all lung cancers2. NSCLC progresses rapidly. Less than 5% of advanced NSCLC patients survive for five years+. 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 worldwide1.
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
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80’000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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References
1) Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American Cancer Society, 2007.
2) Allen J et al. J Natl Compr Canc Netw 2008; 6(3): 285-93.