According to AstraZeneca, Cediranib met the co-primary endpoint of improving progression-free survival (PFS) but showed no improvement in overall survival (OS).
AstraZeneca said that 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 2010, 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.
The 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 program 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.