AstraZeneca has suffered a setback after its investigational oncology agent Recentin failed to match up with Roche’s blockbuster Avastin in a colorectal cancer trial.

The Anglo-Swedish drugmaker has unveiled top-line results of a Phase II/III study evaluating Recentin (cediranib) compared with Avastin (bevacizumab) in patients with first-line metastatic colorectal cancer. The study, HORIZON III, revealed that “clinical activity was observed in the cediranib arm of the study” and there was no statistically significant difference between the two drugs on the efficacy endpoints. However, the efficacy “did not meet the pre-specified criteria for the primary endpoint of non-inferiority in progression-free survival”.

Alan Barge, head of oncology at AstraZeneca, said that “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”. Another colorectal cancer trial, HORIZON II, is assessing Recentin combined with chemotherapy versus the latter alone, and data are expected in the coming months and the company said the results of both studies “will determine the clinical utility, if any, for cediranib in colorectal cancer and decisions regarding regulatory filing”.

Results of a Phase III study with Recentin in treating recurrent glioblastoma are also expected in the first half of 2010, while “exploratory evaluations” of the drug in other tumours are also ongoing.