Recentin Did Not Meet Primary Endpoint in Horizon III Study in Metastatic Colorectal Cancer
LONDON, March 8, 2010-- <!--cpurl-->AstraZeneca<!--/cpurl--> today announced the top-line results of a Phase II/III study evaluating <!--ppurl-->RECENTIN <!--/ppurl--> (cediranib) compared with Avastin (bevacizumab) in patients with first-line metastatic colorectal cancer (mCRC). This study, HORIZON III, assessed the efficacy of cediranib compared with bevacizumab, both in combination with chemotherapy. Clinical activity was observed in the cediranib arm of the study and there was no statistically significant difference between treatment arms on the efficacy endpoints examined.However, the efficacy did not meet the pre-specified criteria for the primary endpoint of non-inferiority in progression-free survival.
The spectrum of adverse events associated with cediranib was broadly consistent with previous studies. HORIZON III continues with ongoing collection of overall survival data.
This is the first of two pivotal studies of cediranib in first-line mCRC. The other study, HORIZON II, is assessing the efficacy of cediranib combined with chemotherapy vs. chemotherapy alone, and data are expected in the coming months. Results from both studies will determine the clinical utility, if any, for cediranib in colorectal cancer and decisions regarding regulatory filing. Data from both of these studies will be submitted to a forthcoming medical meeting in the second half of 2010.
“While we recognised that challenging Avastin would be a
high hurdle, it is still disappointing, despite evidence of
clinical activity with RECENTIN, not to have met the primary
endpoint in this study. The results of the second pivotal study in
the coming months will provide further information on whether
RECENTIN may provide benefit for patients with colorectal cancer
and will inform any decision about possible regulatory
filings,” said Alan Barge, VP & Head of Oncology.
Results of a Phase III study with cediranib in treating recurrent glioblastoma are also expected in the 1st half of 2010. Exploratory evaluations of cediranib in other tumours are also ongoing.
In conjunction with today’s announcement, the Company re-confirms its financial guidance for 2010, as well as the high-level planning assumptions for the period 2010 to 2014 that were provided with its Fourth Quarter and Full Year Results 2009 announcement issued on 28 January 2010.
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NOTES TO EDITORS:
About cediranib and the Phase III study
Preclinical studies have shown that cediranib is an anti-angiogenic compound that inhibits all three vascular endothelial growth factor (VEGF) receptors. Cediranib acts on blood and lymphatic vessels to inhibit growth and spread of the tumour. Cediranib is suitable for once daily oral dosing.
The cediranib Phase III programme in mCRC (HORIZON II and HORIZON III) is designed to evaluate the activity and clinical benefit of 20 mg cediranib in combination with FOLFOX chemotherapy in patients with first-line mCRC.
HORIZON III is a double-blind, randomised trial of cediranib in combination with FOLFOX compared to bevacizumab in combination with FOLFOX. All patients received oxaliplatin-based chemotherapy (FOLFOX) and either 20 mg of cediranib as a once daily oral tablet or 5 mg/kg of bevacizumab administered by IV infusion every two weeks. The primary endpoint was PFS. Non-inferiority assesses to what extent treatments differ by a clinically meaningful amount.
HORIZON II is a double-blind, randomised trial of cediranib plus FOLFOX or XELOX compared to FOLFOX or XELOX alone. The primary endpoints are PFS and overall survival.
REGAL is a Phase III study of cediranib in recurrent glioblastoma multiforme. It is a three arm randomized Phase III study of cediranib alone or in combination with lomustine compared to lomustine alone. The primary endpoint is PFS.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com
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Posted: March 2010