Phase III study confirms benefit of breast cancer drug
A new Phase III study of Avastin in advanced breast cancer has met its primary endpoint of increasing progression-free survival (PFS) compared to chemotherapy alone. In the RIBBON-1 trial, 1,237 women with metastatic HER-2 negative breast cancer, who had not previously received chemotherapy, were given either Avastin (bevacizumab) or placebo in combination with Taxane or anthracycline chemotherapies, or Xeloda. Avastin yielded superior PFS in both treatment groups. RIBBON-1 is the first Phase III study to show Avastin’s benefit when combined with Xeloda as well as anthracycline-based chemotherapies in this patient population. It also substantiates the benefits of Avastin when combined with taxane-based chemotherapies.
Roche 24 November 2008

Zactima reaches primary endpoint in ZODIAC trial
Zactima (vandetanib), AstraZeneca's new multi-targeted anticancer, has succeeded in a Phase III trial which tested it as a second-line therapy in advanced non-small cell lung cancer (NSCLC). Zactima was successful in prolonging progression free survival (PFS) in one trial but it failed in two others to meet its primary PFS endpoint. The 1,391-patient ZODIAC trial tested Zactima in combination with the chemotherapy agents, docetaxel and pemetrexed respectively, comparing the combination with chemotherapy alone. Zactima in combination with docetaxel in NSCLC met its primary PFS endpoint. A positive trend towards prolonged overall survival, a secondary endpoint, was seen but this failed to reach statistical significance. A smaller combination in a study called ZEAL did not show statistical significance and a monotherapy study comparing Zactima with erlotinib or Tarceva (a lung-cancer drug made by Roche) did not demonstrate statistical significance in prolonging PFS. A fourth Phase III trial in pre-treated NSCLC is ongoing.
AstraZeneca 19 November 2008

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GCPj December 2008
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