Thursday, Jun 2, 2011
South San Francisco, Calif. -- June 2, 2011 --Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Astellas Pharma US, Inc. ("Astellas"), today announced results of EURTAC, the first Phase III study with Tarceva® (erlotinib) in Western patients with a genetically distinct type of advanced non-small cell lung cancer (NSCLC). EURTAC showed that first-line Tarceva nearly doubled the time people with NSCLC with EGFR activating mutations lived without their disease getting worse compared with chemotherapy (median progression-free survival or PFS: 9.7 months compared to 5.2 months). Tarceva significantly reduced the risk of the disease getting worse by 63 percent compared with standard chemotherapy (hazard ratio=0.37, p<0.0001). The safety profile for Tarceva was consistent with previous studies in NSCLC. These new data are being presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place in Chicago, June 3 to 7, 2011.
The genetically distinct type of lung cancer studied in EURTAC (epidermal growth factor receptor, or EGFR, activating mutation-positive NSCLC) occurs in approximately 10 percent of lung cancer patients in the Western population and approximately 30 percent of Asian patients. Similar results were observed in another Phase III trial (OPTIMAL) conducted in Asian patients with this form of NSCLC.
"Two studies have now shown that Tarceva as a first-line therapy for EGFR mutation-positive advanced lung cancer increased the time people lived without cancer worsening compared with standard chemotherapy," said Hal Barron, M.D., chief medical officer and head, Global Product Development, Roche. "This is an important step forward in our goal of providing personalized options for people with advanced lung cancer."
"We are pleased with the results from the EURTAC study, which is promising for patients with this genetically distinct type of NSCLC," said Steve Ryder, president of Astellas Pharma Global Development. "The data from the EURTAC study reinforces the role that Tarceva may have in NSCLC patients with a once-a-day oral pill and a known toleration profile."
Roche has applied to the European Medicines Agency (EMA) to extend the current EU label for Tarceva to include first-line use in people with advanced EGFR activating mutation-positive NSCLC. Discussions are ongoing with the U.S. Food and Drug Administration (FDA) regarding a submission that will include the use of a companion diagnostic test to help identify patients with activating EGFR mutations who are appropriate candidates for Tarceva.
About the EURTAC Study
Tarceva?is approved for patients with advanced NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment). Tarceva is also approved for patients with advanced NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second-/third-line treatment). Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.
Important Safety Information for Tarceva in Advanced NSCLC
There have been reports of serious Interstitial Lung Disease (ILD)-like events including deaths in patients taking Tarceva. Serious side effects (including deaths) in patients taking Tarceva include liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); and severe blistering skin reactions including cases similar to Stevens-Johnson syndrome.
Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding have been reported in clinical studies. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva. Patients should call their doctor right away if they have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, vomiting, or stomach pain; new or worsening shortness of breath or cough; fever; eye irritation. Rash and diarrhea were the most common side effects associated with Tarceva in the NSCLC clinical studies.
For full prescribing information on Tarceva, please visit http://www.tarceva.com.
Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies.
The Spanish Lung Cancer Group is a multi-center, multidisciplinary cooperative working group. SLCG affiliates are based in 135 centers in Spain including basic researchers, thoracic surgeons, pathologists, radiotherapists and medical oncologists. SLCG is committed to independent academic research and has included more than 10,000 patients in different studies and trials. In SLCG trials translational research and customized treatment based on genetics are the main priorities.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of Anti-Infectives, Cardiology, Dermatology, Neuroscience, Transplant, Oncology and Urology. For more information about Astellas Pharma US, Inc., please visit our website at http://www.astellas.us or follow us on Twitter at http://www.Twitter.com/AstellasUS.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.