AstraZeneca announced the top-line results of a phase II/III study evaluating Recentin (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 this 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.