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Tarceva Pancreatic Cancer Data Do Not Support Broad Use – ASCO Review

Executive Summary

Results from Genentech/OSI's Phase III trial of Tarceva (erlotinib) in advanced pancreatic cancer do not support broad use, according to a review at the American Society of Clinical Oncology annual meeting

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American Society Of Clinical Oncology Highlights

Provenge cancer vaccine improves survival: Final three-year analysis of Dendreon's prostate cancer vaccine Provenge Phase III D9901 study shows a median survival of 25.9 months for Provenge compared to 21.4 months for placebo, a statistically significant 4.5 month improvement (p=0.01) that "was not due to any imbalances in the patient population," Dendreon reports May 14 at ASCO. An analysis of imbalances between immunotherapy and placebo populations showed no difference in subsequent use of chemotherapy after progression. "In addition, 34% of patients receiving Provenge were alive at 36 months compared to 11% of patients receiving placebo (p=0.0046)." The therapeutic vaccine was well-tolerated among the 127 men with hormone-refractory prostate cancer. An earlier interim analysis of the study did not show significance for time to progression. Provenge failed to meet the final endpoint of time to progression in a separate Phase III trial (D9902A). Dendreon has another pivotal Phase III trial (D9902B) underway, under a special protocol assessment with FDA...

Subgroup Analyses Need Confirmation In Independent Trials - Duke’s George

Findings from subgroup analyses need to be confirmed in an independent trial to be viewed as conclusive, Duke University biostatistician Stephen George said at a recent FDA seminar

AstraZeneca To Revisit Iressa Dosing Following Failed Survival Study

Inappropriate dose selection is one issue AstraZeneca will examine following Iressa's failure to demonstrate a survival benefit in a Phase IV trial in refractory non-small cell lung cancer, CEO Tom McKillop indicated





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