AstraZeneca says that it is moving its oncology agent, Zactima (formerly known as ZD6474), into Phase III trials in the treatment of non-small cell lung cancer.
Zactima has already produced promising Phase II trial results and, if it proves to be successful, could help the Anglo-Swedish company regain some of the footing it lost after its key NSCLC agent, Iressa (gefitinib), failed to show survival benefit in a major clinical trial [[20/12/04b]]. The latter drug was approved back in May 2003 under the FDA’s accelerated approval programme, which permits approval based on a surrogate endpoint that is considered reasonably likely to predict clinical benefit [[06/05/03a]]. However, one requirement for drugs approved under this programme is that the firm in question must study them further after approval to verify the expected clinical benefit, and it was this study that proved to be Iressa's downfall.
A Phase II trial of Zactima, used in combination with Sanofi-Aventis’ Taxotere (docetaxel), met its primary endpoint of progression free survival, according to preliminary data. The Phase III studies will evaluate the product’s anti-tumour activity in NSCLC as well as progression free survival and survival outcomes, beginning in the next few months.