Biopharmaceutical company AstraZeneca plc (AZN,AZN.L) announced Monday that Recentin failed to meet primary endpoint in a late-stage study. The study dubbed HORIZON III was evaluating Recentin compared with Roche Holding AG's Avastin in patients with first-line metastatic colorectal cancer.
Avastin or bevacizumab, jointly developed by Genentech and Roche, is a humanised monoclonal antibody with both US FDA and European approvals for use as a first-line treatment for patients with metastatic colorectal cancer.
HORIZON III, the phase II/III study of AstraZeneca, assessed the efficacy of Recentin, or cediranib, compared with bevacizumab, both in combination with chemotherapy. Clinical activity was observed in the cediranib arm and no significant difference was observed between the treatment arms. The efficacy failed to meet the pre-specified criteria of non-inferiority in progression-free survival.
"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," said Alan Barge, Vice President and Head of Oncology.
The spectrum of adverse events associated with cediranib was broadly consistent with previous studies.
This was the first of two pivotal studies of cediranib in first-line metastatic colorectal cancer. Data from the other study, HORIZON II, which assesses the efficacy of cediranib combined with chemotherapy against chemotherapy alone are expected in the coming months. Results from both studies will determine the clinical utility and decisions regarding regulatory filing.
The company also said that results of another Phase III study with cediranib in treating recurrent glioblastoma are expected in the first half of 2010. Exploratory evaluations of cediranib in other tumours are also ongoing.
In addition, AstraZeneca reaffirmed the financial guidance for 2010 as well as the "high-level planning assumptions" for the period 2010 to 2014 that were provided with the fourth-quarter and full-year results. The company, at that time, had projected core earnings per share range of $5.75 to $6.15 and expected a mid single-digit year-over-year decline in constant currency based revenue for 2010. Currently, the Street expects earnings of $6.00 per share and revenue of $32.55 billion for fiscal 2010.
AZN.L shares are currently trading at 2,962.50 pence per share, down by 1.10%, on the London Stock Exchange.
AZN closed Friday's regular trade at $45.46 on the NYSE.
by RTT Staff Writer
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