ASTRAZENECA LAUNCHES STUDY OF TREATMENT FOR NSCLC

AstraZeneca has begun a new Phase III study of its investigational once-daily orally administered drug, Zactima (vandetanib). Study 36 will investigate the addition of vandetanib to Alimta (pemetrexed) as second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of first-line cancer treatment. The trial will be conducted in 20 countries and is expected to enroll at least 508 patients.

As its primary objective, Study 36 will evaluate progression-free survival with vandetanib 100 mg plus pemetrexed 500 mg/m2 compared with pemetrexed 500 mg/m2 plus placebo in patients with advanced NSCLC who have previously received cancer treatment. The study will also assess overall survival, objective response rate, disease control rate, duration of response, effect on disease-related symptoms, time to deterioration of disease-related symptoms, safety and tolerability, and population pharmacokinetics.

Study 36 forms part of an extensive ongoing global clinical development program for vandetanib in NSCLC and is the fourth Phase III study in this tumor.

Zactima is an investigational drug being studied as a multitargeted compound, to evaluate its effect on the inhibition of key cell signaling pathways involved in tumor growth and spread. Tumor cells are targeted through inhibition of epidermal growth factor receptor and rearranged-during-transfection (RET) tyrosine kinases, while tumor blood supply is targeted through inhibition of vascular endothelial growth factor receptor tyrosine kinases. RET tyrosine kinase activity is an important growth driver in certain tumors, according to the company.