AstraZeneca Announces Results of Recentin HORIZON II Phase III Trial in Metastatic Colorectal Cancer
Published date :28 May 2010
AstraZeneca today announced the top-line results of the HORIZON II Phase III study evaluating RECENTIN (cediranib) for the first-line treatment of metastatic colorectal cancer (mCRC). Cediranib met the co-primary endpoint of improving progression-free survival (PFS) but showed no improvement in overall survival (OS).
The adverse events associated with cediranib during this study were broadly consistent with previous studies. HORIZON II is the second of two pivotal studies of cediranib in first-line mCRC. In March, the HORIZON III study of cediranib plus chemotherapy versus bevacizumab plus chemotherapy did not meet the primary endpoint of PFS.
Based on the results of these two trials, AstraZeneca does not intend to file regulatory submissions in first-line mCRC.
The results of a Phase III study evaluating cediranib for the treatment of recurrent glioblastoma (REGAL) are expected soon. In addition, AstraZeneca is currently examining whether cediranib may have applications in a number of different tumour types.
Data from HORIZON II and HORIZON III will be submitted to a forthcoming medical congress.
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NOTES TO EDITORS:
About cediranib and the Phase III study programme
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) was designed to evaluate the activity and clinical benefit of 20 mg cediranib in combination with FOLFOX or XELOX chemotherapy in patients with first-line mCRC.
HORIZON II was a double-blind, randomised trial of cediranib plus FOLFOX or XELOX compared to FOLFOX or XELOX alone. The primary endpoints were PFS and OS.
HORIZON III was 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.
In HORIZON III, cediranib did not meet the pre-specified criteria for the primary endpoint of superiority or non-inferiority in PFS compared to Avastin (bevacizumab). However, there was no statistically significant difference on PFS between the two treatment arms.
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.
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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