AstraZeneca: phase 2 studies of Zactima show progression free survival in lung cancer

By Lisa Kerner

Charlotte, N.C., June 6 - AstraZeneca said its two phase 2 studies (Trial 003 and 006) of Zactima for the treatment of lung cancer met their primary endpoint of progression free survival (PFS).

Zactima is a compound which targets both epidermal growth factor receptor and vascular endothelial growth factor receptor cell signaling pathways, according to a company news release.

The study results were presented at the 2006 American Society of Clinical Oncology meeting in Atlanta.

Trial 006 evaluated the PFS of Zactima at dosages of 100 mg or 300 mg compared to a placebo in 127 patients with advanced non-small cell lung cancer receiving standard chemotherapy treatment. Adding the 100 mg or 300 mg of the compound to docetaxel increased median PFS to 19 weeks and 17 weeks, respectively, compared to 12 weeks with docetaxel plus a placebo.

In the two-part Trial 003, 300 mg of Zactima administered as monotherapy was compared to 250 mg of gefitinib administered as monotherapy in 168 patients with advanced non-small cell lung cancer.

Patients receiving Zactima 300 mg had a mean PFS of 11.9 weeks compared to 8.1 weeks for the gefitinib group.

Of the eligible patients in the second part of the trial B, 43% (16/37) of patients who switched to Zactima from gefitinib and 24% (7/29) of those who switched to gefitinib from Zactima had disease control for more than eight weeks.

AstraZeneca said in both studies, Zactima did not demonstrate a significant effect on overall survival, possibly due to the small number of patients.

Enrollment of 1,200 patients has started in the company's phase 3 study of Zactima (Trial 32) in advanced non-small cell lung cancer.

AstraZeneca is a pharmaceutical company and health care services supplier based in London.

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