Next generation of trials with targeted agents
Prof Richard Schilsky - Chief Medical Officer of the American Society of Oncology (ASCO)
ASCO’s initiatives in precision medicine break down into two broad categories, educational programmes and then opportunities to learn from the real world practice of medicine. So with respect to educational programmes we talked about ASCO’s clinical practice guidelines and how they’re beginning to focus more and more on the appropriate use of biomarkers in the molecular work-up of newly diagnosed cancer patients. We talked about ASCO’s new initiatives in molecular tumour boards, a new monthly programme where a clinical case along with some genomic test results are posted online, there’s a two week opportunity for a crowdsourcing of commentary so anybody can log on and leave an opinion about how to interpret the case, how to interpret the genomics. Then there’s an expert analysis of the case that’s then posted by a clinical oncologist and a molecular pathologist that provides a definitive analysis of the case and that’s archived on the website for educational purposes.
I also mentioned two new educational curricula, one in hereditary cancer genetics, really an educational programme to inform people about germline abnormalities and how they predict whether risk of cancer. And then a just recently launched educational programme in tumour genomics, again to provide people with the landscape of what are the prevalent cancer mutations, what are the technologies for interrogating the cancer genome and how to understand this very, very complicated world of precision medicine and genomics as it applies to cancer.
On the learning from real world medical evidence side, ASCO is launching two major initiatives to try to accomplish that. One is a clinical study for patients with advanced cancer who have had a genomic profile performed on their cancer that’s just a treatment with a commercial drug given off label that might benefit them. That’s a study called TAPUR, the Targeted Agent and Profiling Utilization Registry. The goal of TAPUR is really to see what we can learn from observing the practice of prescribing drugs off label to patients with advanced cancer whose tumour has an actionable genomic variant and whether this practice of using drugs off label is actually worthwhile or not.
ASCO’s bigger initiative in learning from real world practice is called CancerLinQ. CancerLinQ is a very ambitious effort designed to collect the complete electronic medical record from every cancer patient from every clinical practice in America that chooses to participate and to collect in a data warehouse the electronic medical records of millions of cancer patients, aggregate that information, de-identify it, and then learn from it in a variety of different ways.