Healthcare Industry News: tyrosine kinase inhibitor
News Release - June 4, 2007
Investigational Drug Cediranib (AZD2171) Shows Promise in Patients With Recurrent Glioblastoma (GBM)Phase II GBM study presented at ASCO with cediranib - a selective VEGF signaling inhibitor - shows over a quarter of patients alive and progression- free at six months(1)
CHICAGO, June 4 (HSMN NewsFeed) -- Data for the investigational agent cediranib (AZD2171) were presented today at the annual meeting of the American Society of Clinical Oncology (ASCO) from a study in patients with recurrent glioblastoma (GBM), an invasive form of brain tumor with a high unmet medical need. (1)
Cediranib Phase II monotherapy study in recurrent glioblastoma (GBM) Results from the National Cancer Institute (NCI) sponsored study at the Massachusetts General Hospital (MGH) Cancer Center, showed 8 patients (27.6%) of the 31 patients with recurrent glioblastoma treated with cediranib, were alive and progression-free at six months.(1) Recurrent glioblastoma is the most aggressive form of primary brain tumor. The dose limiting toxicities most commonly observed in this study included hypertension, fatigue, and diarrhea.
Cediranib is a selective VEGF signaling inhibitor that targets all three VEGF receptors.(2) VEGF signalling is a key driver of angiogenesis -- the formation of new blood vessels that tumors need to grow and spread. Cediranib is currently in Phase II/III development for advanced non-small cell lung cancer (NSCLC) and advanced colorectal cancer (CRC) -- as well as being investigated as part of a wide-ranging signal search program in other tumors such as glioblastoma.
Commenting on these results, Dr. Tracy Batchelor, MD, chief of Neuro- Oncology in the Massachusetts General Hospital (MGH) Cancer Center, Associate Professor of Neurology at Harvard Medical School and lead author of the Phase II study said, "These encouraging data showing effects on progression-free survival warrant further investigation to validate these initial trial results."
"In addition, cediranib alleviated brain swelling (edema) in many patients. Edema is a debilitating symptom in many brain cancer patients and is currently treated with steroid drugs, which can carry their own debilitating side effects. Based on the first 16 patients a steroid-sparing effect was demonstrated in most patients and was associated with the normalization of tumor vessels. This normalization might help to secure delivery and improve effectiveness of other therapeutic techniques such as chemotherapy drugs and radiation therapy," said Dr. Batchelor.
"The prognosis for recurrent glioblastoma patients is poor," commented AstraZeneca's Dr. Nick Botwood, Global Medical Director for cediranib. "These are promising Phase II results and discussions are ongoing with Dr. Tracy Batchelor and his group regarding a confirmatory study in recurrent glioblastoma."
Cediranib Phase II study in metastatic renal cell carcinoma (RCC)
Another ongoing NCI sponsored cediranib Phase II study presented at ASCO 2007 by investigators from the Princess Margaret Hospital in Toronto, looked at cediranib in first line, progressive, unresectable, advanced metastatic renal cell carcinoma (RCC).(3)
Twenty-seven patients receiving cediranib as monotherapy were able to be evaluated for response with a response rate of 33 percent (9 out of 27 patients) and tumor control rates of 66.7 percent (18 out of 27 patients).(3) The most common toxicities were fatigue, hypertension, diarrhea, and voice alteration.
"Renal cell carcinoma is a chemoresistant disease which has traditionally been difficult to treat, resulting in poor prognosis for patients hence these early data are encouraging," commented Professor S. Sridhar of the Princess Margaret Hospital Phase II Consortium, Toronto, Canada.
These results support another cediranib publication of RCC patients presented at ASCO 2007.(4) In addition, an ongoing AstraZeneca sponsored Phase II, randomized study is currently investigating the efficacy of cediranib in patients with metastatic or recurrent RCC who have had no previous anti-VEGF therapy.
About the National Cancer Institute
The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
The NCI is a component of the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS) in the Department of Health and Human Services (DHHS).
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com
The statements herein include forward-looking statements. By their nature, forward-looking statements and forecasts involve risk and uncertainty. For a discussion of those risks and uncertainties please see the company's Annual Report/Form 20-F for 2006.
1. Batchelor T et al. ASCO June 2007, Abstract no. 2001
2. Wedge et al., 2005 Cancer Research Paper Wedge SR et al: AZD2171: a highly potent, orally bioavailable, vascular endothelial growth factor receptor-2 tyrosine kinase inhibitor for the treatment of cancer. Cancer Res. 2005 65(10):4389-400.
3. Sridhar S et al. ASCO June 2007, Abstract no. 5093
4. van Herpen CML et al. ASCO June 2007 Abstract no. 3560
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