Upcoming #LCSM Chat, Thursday, March 27 at 5 pm PT, 8 pm ET: Should All Targeted Rx Lung Cancer Trials be Biomarker-Selective?
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 was just reported as negative in the broad population, 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.
If our large randomized trials, requiring hundreds to thousands of patients and costing millions of dollars and years to conduct, are extremely likely to return as negative and require a more refined population with a prospectively defined target, how should we conduct trials of targeted therapies in lung cancer? With that in mind, these are the questions we’ll tackle in our upcoming #LCSM chat on Thursday, March 27th, at 8 PM ET, 5 PM PT:
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 widely available enough today to limit 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”?
We need insights from people running trials, who would enroll patients on trials, and those seeking trial options. We hope you’ll join us for a lively tweet chat, moderated by Dr. H. Jack West, 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!