Comprehensive Genomic Profiling in Cancer Care

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EP: 1.Comprehensive Genomic Profiling in Cancer Care

EP: 2.Payer Perspective: Adapting to Precision Medicine in Cancer Care

EP: 3.Information Provided by Comprehensive Genomic Profiling Assays

EP: 4.Molecular Profiling Complexities and Coverage Decisions

EP: 5.Driver Mutations and Cancer Care

EP: 6.Types of Molecular Assays Used in Oncology

EP: 7.Shifting Over to Comprehensive Genomic Profiling in Oncology

EP: 8.Comprehensive Genomic Profiling and Informed Decision-Making

EP: 9.Molecular Testing in Oncology: Current Practice Patterns

EP: 10.Comprehensive Genomic Profiling and Clinical Actionability

EP: 11.Comprehensive Genomic Profiling and Procedure Coding

EP: 12.Comprehensive Genomic Profiling: When to Retest Patients

EP: 13.Molecular Testing Turnaround Times and Treatment Decisions

EP: 14.Reflex Testing and Reimbursements for Oncology Treatment

EP: 15.Future Outlook: Comprehensive Genomic Profiling in Oncology

EP: 16.Future Outlook: Coverage for Comprehensive Genomic Profiling in Oncology

EP: 17.Comprehensive Genomic Profiling in Community Oncology

Bruce Feinberg, DO: Hello. Welcome to this AJMC® Peer Exchange program titled “Advancing Precision Medicine Through Comprehensive Genomic Profiling (CGP).” I’m Dr Bruce Feinberg, the vice president and chief medical officer at Cardinal Health Specialty Solutions. Joining me in this discussion are my colleagues Dr Mark Kris, a medical oncologist specializing in thoracic oncology at Memorial Sloan Kettering Cancer Center [in New York, New York]; Kenna Mills Shaw, the executive director of the Institute for Personalized Cancer Therapy at [The University of Texas] MD Anderson Cancer Center [in Houston, Texas]; and Mr Eugean Jiwanmall, a senior research analyst for medical policy and technology evaluation at Independence Blue Cross. Our panel of experts will discuss comprehensive genomic profiling and how it’s impacting the oncology space for payers and for clinicians. Thank you for joining us. Let’s begin.

I want to start with this first segment, which we’re going to be calling introduction to comprehensive genomic profiling, or CGP. In general, most people aren’t familiar with genomic profiling. This would be somewhat of a level set, but some of it will be philosophical in terms of how we interpret it and the role genomic profiling within the broader field of precision medicine. As we think about it, I might pose that we’re at an inflection point. We’re just 4 years from the approval of the first comprehensive genomic profile, which was approved by the FDA as a test for patients with solid-tumor cancer. After 4 years, we may be at the point where comprehensive genetic profiling is no longer the last thing you do when you’ve exhausted all standard of care. Rather, it has become the first thing you do before you initiate any systemic therapy in a patient with advanced cancer. Over 90 minutes today, we’re going to have conversations that’s going to help you determine where we are with regard to that inflection point.

To start, let’s get an idea of the evolution that dates before this first approved test came to the market. You could argue that modern medicine and modern cancer care are a story of precision. I’m going to go to Mark on this, who’s an expert in lung cancer—we started with lung cancer. Then it was small cell and non–small cell. Then non–small cell became histology-based adenocarcinoma squamous cell carcinoma, and then we started to add targets. Now we have genomic profiling. Today non–small cell lung cancer could be 30 different diseases with targeted therapies that can have some intervention, either therapies approved or in the pipeline. We have to think about when we’d say personalized medicine and precision medicine. What’s the role on genomic profiling within that? How do we even define precision?

Mark, let me start with you about this evolution and how we distinguish precision and personalized medicine. Maybe that becomes personalized in terms of how you distinguish it vs is it distinguished within thoracic oncology and within oncology in general?

Mark G. Kris, MD: I’m not sure there’s any consensus definition for the terms personalized or precision medicine. It’s what you make of them. I was always jealous of investigators working in the breast cancer field because they had some extremely potent targets for therapy. By the discovery of those targets and particularly the estrogen receptor, you could clearly choose therapies that were very likely to be beneficial. Generally, they had fewer adverse effects as well. For patients who didn’t have that characteristic, you spared them the adverse effects of those drugs. It was always a dream of mine that we could do the same thing for lung cancer, that we could find those very potent targets. Bruce, you already outlined the evolution that we had going to the histologic definition and later the molecular definition. To me, it’s not necessarily a gene that we’re looking at. Obviously, genes are behind all the proteins that we talk about. It’s having a measurement—I’ll call it a marker—that can have that potent ability to select patients for the treatment to identify patients who wouldn’t benefit with the treatment to do so with fewer adverse effects. To me, the precision is interrogating a tumor, finding characteristics of a tumor that lead to better outcomes. That’s the essence of precision medicine.

Bruce Feinberg, DO: Kenna, do you agree or disagree? How would you expand on that?

Kenna R. Mills Shaw, PhD: I agree. We think about biomarkers in terms of precision medicine. We focus on 3 kinds of biomarkers in this context. Those that are predictive, which Dr Kris just spoke of. Will a biomarker—something we can test, often in NGS [next-generation sequencing]—predict whether a patient will respond or might be resistant to a specific targeted agent or another agent? We can also think of them being diagnostic or prognostic. Maybe we have some biomarkers and we can’t decide on a specific targeted-driven treatment, but it could be prognostic in terms of whether we have to be more aggressive or less aggressive. We can watch and wait with certain leukemias, depending on their TP53 status. We think of biomarkers that way for the most part.

Transcript edited for clarity.