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Clinical trial success influenced by biomarker- and receptor-targeted therapies in NSCLC
Date:2/14/2014

DENVER Over the past decade, a great clinical focus has been directed at developing new and innovative therapies for advanced non-small cell lung cancer (NSCLC). An analysis of clinical trials evaluating these therapies demonstrates that the cumulative success rate for new agents for advanced NSCLC is lower than the industry-estimated rate. However, biomarker- and receptor-targeted therapies were found to substantially increase clinical trial success.

The analysis was designed to evaluate the risk of clinical trial failure in advanced (stage IIIb-IV) NSCLC drug development over the past 14 years. The success rate was defined as the likelihood that a new drug would pass all phases of clinical trial testing and be approved. Success rates were compared with rates estimated by the biopharmaceutical industry as well as rates determined by risk analysis research in other disease indications.

The success rate for NSCLC drug development was 11%, which is lower than the industry estimate of 16.5%. However, success rates were higher for certain drug indications; the cumulative success rate was 62% for biomarker targeted therapy, which was nearly six times higher than the rate for trials without a biomarker targeted indication (11%). The analysis also showed that success rates became worse with each new phase of testing, which indicates that earlier phase trials may provide little help in ensuring the success of later phase trials.

"The findings suggest that some treatment modalities and drug design strategies may help to decrease drug-development risk and promote the development of innovative drugs to treat advanced NSCLC," says lead author Jayson Parker, PhD, MBA, of the Department of Biology, University of Toronto at Mississauga, Toronto, Ontario, Canada. A report on the findings of the analysis is published in the February issue of the International Association for the Study of Lung Cancer's journal, the Journal of Thoracic Oncology'/>"/>

Contact: Kristin Richeimer
kristin.richeimer@iaslc.org
720-325-2953
International Association for the Study of Lung Cancer
Source:Eurekalert

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