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Dr. Jack West is a medical oncologist and thoracic oncology specialist, and Executive Director of Employer Services at the City of Hope Comprehensive Cancer Center in Duarte, CA.

Upcoming #LCSM Chat: Are Our Negative Trials in Lung Cancer from Poor Target Selection?
Sat, 03/22/2014 - 13:12
Author
Howard (Jack) West, MD, Associate Clinical Professor, Medical Oncology, Executive Director, Employer Services, Founder, President and CEO of GRACE

How should we conduct trials of targeted therapies in lung cancer if large randomized trials require hundreds to thousands of patients, cost millions of dollars and years to conduct, but are extremely likely to have negative results and will require a more refined population with a prospectively defined target? We'll tackle that question in our upcoming #LCSM chat on Thursday, March 27th at 8 PM ET, 5 PM PT. Topics will include:

1) Do we need to identify a target before committing people, money, & time to large lung cancer trials? Should we abandon targeted therapy trials in broad populations?

2)  Is tissue for testing and molecular testing available enough for targeted therapy trials, or will too many potential patients miss out? Will this be a hurdle to access?

3) Will those without any "targetable markers"  be left without trial options? Will we exclude too many "molecular marker orphans"?

ASCO, the American Society for Clinical Oncology, is promoting a new principle that targeted therapies should be used only in targeted patients, as part of a general trend that we need to move away from trials that test new non-chemotherapy agents in a  broad population. Meanwhile, we've just recently seen a few high profile negative trials in the last few weeks, such as the large phase III METLung trial of "METMAb" or onartuzumab, the monoclonal antibody against the target MET (mesenchymal epithelial transition), combined with Tarceva (erlotinib), and also the MAGE-A3 vaccine in the MAGRIT trial done as adjuvant treatment for resected non-small cell lung cancer.

Increasingly, our negative trials are followed by subset analyses that identify a potential subgroup that may be significant beneficiaries, often offset by larger groups that don't benefit or are even harmed. As an example, the MAGRIT trial, just reported as negative in the broad population of post-operative patients and in the subset of patients who didn't also receive adjuvant chemotherapy (the trial allowed patients to receive the vaccine or placebo either after adjuvant chemo or as the only adjuvant treatment), but the study is still looking at an investigational gene signature that may predict for significant benefit vs. non-benefit with the MAGE-A3 vaccine.  

We need insights from people running trials, who would enroll patients on trials, and those seeking trial options.  I hope you'll join us for a lively tweet chat Thursday evening. Just check out http://www.tchat.io/rooms/lcsm at the appointed hour, or use the twitter client of your choice and follow the hashtag #LCSM. Hope to see you then!

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