Two More Phase III Zactima Trials Reach Full Enrollment
This article was originally published in The Pink Sheet Daily
Executive Summary
AstraZeneca’s investigational drug for non-small cell lung cancer remains on track for an NDA filing this year.
|
With one of four scheduled Phase III trials already at full enrollment, AstraZeneca announced March 12 that two more trials for experimental oncology drug Zactima (vandetanib) now are fully enrolled. The Anglo-Swedish pharma plans to file an NDA later this year for an indication as second-line therapy for non-small cell lung cancer. Zactima could have an advantage over Roche/OSI's Tarceva (erlotinib) if it reaches the NSCLC market because it would target the disease with multiple mechanisms of action, AstraZeneca's Executive Vice President of Discovery Research Jan Lundberg told "The Pink Sheet" DAILY earlier this year, (1 (Also see "AstraZeneca Executive VP, Discovery Research, Jan Lundberg: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 26 Feb, 2008.)). The once-daily oral therapy is intended to work by inhibiting vascular endothelial growth receptor factor 2 (VEGFR2), which would block blood supply development for tumors, and inhibiting epidermal growth receptor factor (EGFR), which could inhibit cancer cell growth and survival. AstraZeneca says Zactima also inhibits RET kinase activity, which is vital to growth and development of certain tumors. Enrollment now is complete, the company reports, for the Phase III ZODIAC trial, which studies Zactima 100 mg once-daily in tandem with docetaxel versus docetaxel alone in 1,380 patients with locally advanced or metastatic NSCLC after failure of first-line therapy. Also fully enrolled is ZEAL, which studies the same dose combined with Eli Lilly's Alimta (pemetrexed) 500 mg/m2 every three weeks compared with placebo plus pemetrexed. The ZEAL trial involves 510 patients with locally advanced or metastatic NSCLC who have failed first-line therapy. Both studies will use a randomized, double-blind design. Data from both are expected later this year. Already fully enrolled is the Phase III ZEST study, which compares the efficacy and safety of Zactima with Tarceva (2 (Also see "AstraZeneca Expects Phase III Zactima Data For NSCLC In 2008" - Pink Sheet, 30 Nov, 2007.)). Currently enrolling patients is a fourth Phase III trial, ZEPHYR, which tests Zactima plus best supportive care against best supportive care alone. In addition to NSCLC, AstraZeneca also is investigating Zactima to treat medullary thyroid cancer. The firm has been awarded orphan drug and fast-track status by FDA for that indication. -Joseph Haas ([email protected]) |