AstraZeneca adds to Zactima Phase III lung cancer program
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
AstraZeneca continues to pursue broad labeling for its oral targeted therapy Zactima (vandetanib) with a fourth Phase III trial in non-small cell lung cancer. The recently initiated trial, Study 36, will add data on another chemotherapy combination, with Lilly's Alimta (pemetrexed). An ongoing Phase III, Study 32, combines Zactima with Sanofi-Aventis' Taxotere (docetaxel), a combination that was also part of the Phase II program. AZ also tested single-agent Zactima in Phase II; ongoing Phase III Study 57 is evaluating monotherapy with Zactima or Genentech's Tarceva (erlotinib) in a head-to-head targeted therapy comparison in second- and third-line NSCLC. Another Phase III trial is enrolling in third- and fourth-line patients who have failed both chemotherapy and an EGFR inhibitor like Tarceva. The newest Phase III is expected to enroll 508 patients who failed at least one chemotherapy regimen; the first patient entered Study 36 in January 2007. Progression-free survival is the primary endpoint of Study 36...