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Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology
Date:5/30/2009

d NSCLC.

Evaluation of secondary endpoints in the ZODIAC and ZEAL studies showed that the addition of vandetanib to chemotherapy significantly improved objective response rate, which is a measurement of tumor shrinkage (ZODIAC: 17% vs. 10%, P<0.001; ZEAL: 19.1% vs. 7.9%, P<0.001), the studies also showed that adding vandetanib to chemotherapy resulted in a significantly longer time to deterioration of disease related symptoms (ZODIAC: HR 0.78, P=0.002, FACT-L Lung Cancer Subscale; ZEAL: HR 0.61, P=0.004, Lung Cancer Symptom Scale). Overall survival in both studies showed a positive trend, although they did not reach statistical significance (ZODIAC Study: HR 0.91, 97.52% CI 0.78-1.07: P=0.196; ZEAL Study: HR 0.86, 97.54% CI 0.65-1.13; p=0.219).

The observed safety profile in both studies was consistent with previous studies with vandetanib in NSCLC. The most common adverse events associated with vandetanib included rash, diarrhea and hypertension (ZEAL); rash, diarrhea and neutropenia (low white blood cell count) (ZODIAC). Incidence of protocol-defined QTc prolongation was <2.0 percent in both studies and was not associated with symptoms.

"There are more deaths from lung cancer alone than from breast, colon, and prostate cancers combined - and it's extremely difficult to treat," said Professor Roy Herbst, M.D., Ph.D., The University of Texas M. D. Anderson Cancer Center, Texas, Principal Investigator on the ZODIAC study. "The ZODIAC study showed adding vandetanib to chemotherapy improved progression-free survival, in patients who have few, if any options for treatment."

Results from a third Phase III study, ZEST(3), were also presented at this year's ASCO. While the primary objective of demonstrating a statistically significant prolongation of PFS for vandetanib was not met in this study, in a pre-planned non-inferiority analysis, vandetanib was shown to have similar efficacy to
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SOURCE AstraZeneca Pharmaceuticals
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