Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 33 of 51

32 Clinical OMICs July/August 2019 already testing, why not? It's a win-win. If we test, we are able to guide physicians in immediate clinical decision making with concrete evidence, potentially improving patient out- comes. If we collect and pool those outcomes from as large a patient population as possible, we can apply the data to help guide physicians' clinical decision making at a population level, accelerate discovery, and optimize existing approaches. We can also identify the cross-walk between driver mutations and pathways to open up therapeutic avenues across tumor types, or suggest new combination strategies. In essence, pro- viding the fuel that will keep the engine of discovery driv- ing us forward and, in doing so, fundamentally changing the future for people who are yet to be diagnosed with cancer. Some much needed progress in pancreatic cancer Results from the POLO study also reinforced the benefits of a biomarker-led approach, this time in pancreatic cancer. Pancre- atic cancer is characterized by poor outcomes, partly due to a lack of targets for precision therapeutics and a reliance on che- motherapy. Germline mutations in the BRCA1/2 genes play a pivotal role in the devel- opment and progression of pancreatic cancer and POLO is the first randomized phase III study to apply this knowl- edge to a biomarker-led therapeutic approach. The study demonstrated that maintenance therapy with the PARP inhibitor olaparib nearly halved the risk of dis- ease progression after che- motherapy versus placebo in BRCA-mutated pancreatic cancers. This is not only encour- aging news for pancreatic cancer patients, but it provides yet more evidence for the utility, and thus the need for, routine testing at the point of diagnosis and should help to redefine the standard of care for this type of cancer. Drugging the undruggable From difficult-to-treat cancers to 'undruggable' targets, one announcement from Amgen held significance for me and many others that went beyond the results of the study. The ubiquity of KRAS mutations in so many cancers has made it one of the most researched—and frustratingly elusive—tar- gets in precision medicine. But early data for Amgen's KRAS inhibitor show us that good things might come to those who wait. In a small Phase I study of 10 heavily pretreated col- orectal and lung cancer patients, results demonstrated that the drug halted tumor growth in the majority of patients, and shrank tumors in half of those with lung cancer. It was a very small study, and there is a long way to go before a KRAS inhibitor reaches the clinic, so why all the excitement? This is not just a potential watershed moment for KRAS inhibition—to me it embodies the tipping point for precision medicine I've touched upon before and highlights the decades of research and thinking that have brought us to where we are today. All of these examples serve to demonstrate how far we have come in such a short time. The sheer number of bio- marker-led approaches that are being explored or validated today would have seemed unimaginable a few years ago, and the benefits of that research are being felt by scientists, physicians, regulators, and of course, patients. Harmonizing the future of data But this is a tipping point, not a finale. How do we ensure that we move toward a future where we can maintain and build on the progress we are making? One final announcement from ASCO concerns perhaps one of the most important chal- lenges we face and brings us back to the panel discussion that kicked off my ASCO this year. If the quality and depth of data is key to the future of precision medicine, how do we find a way to harmonize the reporting, collection, integration, and security of that data across sites and across borders? With this in mind, I was encouraged to see the launch of mCODE, or 'Minimal Common Oncology Data Elements', a joint collaboration between ASCO and a number of stake- holders. The premise of the project is that the variability of electronic health record software makes it difficult to cap- ture and pool data into a central resource. mCODE is an ini- tial set of data standards covering domains such as disease, genomics, treatment, and outcomes and is free to download at The aim is to create a common lan- guage between sites—and eventually across borders—that will harmonize the way we collect data. I see this as a step in the right direction, and an example of how collaboration across the oncology landscape can deliver solutions to some of the challenges we face. (continued from previous page) Cindy Perettie, CEO, Foundation Medicine "The sheer volume of new knowledge and thinking presented over the course of a few days was astounding."

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