Genetic Engineering & Biotechnology News

JUN15 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Page 28 of 37 | Genetic Engineering & Biotechnology News | JUNE 15, 2018 | 27 complex as cancer. It revealed that treating melanoma patients with Zelboraf ® (Vemu- rafenib), a drug that inhibits their mutated B-Raf, selects for tumor cells harboring the more aggressive N-Ras mutation. This find- ing allows doctors to start treating their melanoma patients right at the outset with a drug combination including Cotellic ® (co- bimetinib), a MEK inhibitor that acts down- stream in the N-Raf pathway. Presumably, as NGS technologies become more accurate, less expensive, and more widely used, they may reveal other unexpected relationships like this that will also help patients. Jordi Rodon-Ahnert, M.D., associate pro- fessor in the Department of Genomic Medi- cine and clinical co-director of the Department of Precision Oncology Decision Support Team at the University of Texas MD Anderson Can- cer Center, is concerned that cancer immuno- therapy is too hyped—and that we have not even reached the peak of that hype yet. "CAR-T cells targeting CD-19 cured leu- kemia in kids, which is a super-aggressive disease that was highly refractive to every- thing," said Dr. Rodon-Ahnert. "PD-1 in- hibitors gave response rates never seen be- fore, in many different tumor types. They were really very impressive." So the hype is hardly a surprise; it is fol- lowing the same trajectory as most promis- ing new innovations, as outlined in Gartner's Hype Cycle. Nevertheless, "it makes clini- cal research go in a single direction without thinking," he warns. "We need to think out- side of the box and not just do what Pharma says, even though it is fashionable." The heady promise of immunotherapy makes it easy to forget that not every drug, nor every drug combination, will yield results as tremendous as those that started the frenzy. He cited Epacadostat as an apt cautionary tale. The IDO1 inhibitor, made by Incyte, failed to deliver any benefit as a combination drug in Phase III clinical trials against meta- static melanoma and non-small cell lung can- cer—causing Incyte's stock to plummet. This may be because the Phase II random- ization aspect of clinical studies was kind of skipped; the Phase III trials were undertaken based only on a Phase I cohort, according to Dr. Rodon-Ahnert. "Researchers need to push back and make thoughtful decisions, and not just do what everyone else is doing," he maintains. Combatting the Hype But there are steps being taken to com- bat this hype. Somak Roy, MBBS, assistant professor of pathology at University of Pitts- burgh Medical Center and the chair of the Working Group at the Association of Mo- lecular Pathology (AMP), says that AMP re- cently released three guideline reports. These reports aim to provide the cancer genomics community with the appropriate tools and guidance to improve the entire NGS work- flow and better incorporate the latest tech- nological innovations in molecular pathol- ogy. All three reports have been published in The Journal of Molecular Diagnostics. "Before these guidelines, each lab was left on its own so validation was variable and in- efficient. AMP can help labs reduce the time it takes to optimize their validation. Many of the guidelines are commonsensical and have been implemented on a piecemeal basis. But AMP can provide labs with a straightfor- ward, standardized checklist"—a technique promoted by Atul Gawande in his book, The Checklist Manifesto, that has been proven to It's Here. The most highly anticipated new journal of 2018 It's Here. Now available in print and online Subscribe at See Molecular Diagnostics on page 28 Translational Medicine " In terms of NGS applications in drug discovery and development, NGS can be used to understand disease biology and to target key pathways driving the disease." —Prashun Mishra, Ph.D., Agility Pharmaceuticals

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