NEW YORK (GenomeWeb) – Genomically guided medicine has had the biggest impact in cancer.
Major cancer centers around the country are testing patients with genomic tests to try to personalize their treatment. Healthcare technology company NextGxDx estimates there are approximately 1,400 genomic test panels for profiling cancer and about 900 panels for hereditary cancer testing currently on the market. The government has launched trials, such as TAPUR and MATCH, exploring the precision medicine hypothesis in cancer. And earlier this year, US Vice President Joe Biden launched the $1 billion Moonshot to Cure Cancer, aiming to translate advances in genomics and immunotherapy into treatments that make the disease a thing of the past.
Intermountain Healthcare has been an early adopter of cancer genomics. Since 2013, the Utah-based healthcare system has been offering all advanced cancer patients the chance to receive genomic profiling on a 100-gene panel it performs internally using Illumina's MiSeq.
Last year, Intermountain conducted genomic testing for just under 500 advanced cancer patients. For close to 80 percent of those patients, testing yielded an "actionable result," meaning it identified a genomic alteration that was targetable by an available drug or a drug in clinical trials.
The organization has also applied to become one of seven large, integrated healthcare systems that will partake in the Precision Medicine Initiative, launched by President Barack Obama last year.
Although these are exciting times in oncology, the proliferation of genomic tests, new treatment opportunities, and novel study designs have placed pressure on community oncologists to keep up with rapidly advancing science. For genomic medicine to truly proliferate in the community, where 85 percent of cancer patients receive care, oncologists need support, Lincoln Nadauld, director of cancer genomics at Intermountain, told GenomeWeb in a recent interview.
Below is an edited transcript of the conversation.
As an oncologist practicing in the community setting, what was your reaction to the announcement of the Moonshot to Cure Cancer?
It is a very exciting time in cancer. There are so many new drugs and diagnostic technologies available that it's allowing us to take this precision medicine approach. So, I was very happy to see that at a national and federal level, leaders have recognized that previously we declared war on cancer under the direction of President Nixon in 1971, and now we have sufficiently developed enough new technology and science that we need to have another push at transforming cancer, turning it into a chronic disease or in some cases even curing it. I guess that's a long way of saying that I was thrilled by the announcement. It's terrific, and oncologists across the country are very pleased with the idea of having a dedicated, collaborative effort toward cancer.
Some people have criticized the banner under which the project was launched — the "Moonshot to Cure Cancer" — because it doesn't align with the present view of cancer as not one but many diseases, often distinguished by genomic abnormalities. What do you think about that?
I understand the criticisms. In some respects, I agree that cancer is not one disease, and so stating that we're going to cure cancer tends to ignore the heterogeneity. It really is dozens or may be even hundreds of different diseases that are collectively called cancer. However, there are some principles across these different disease types that are transferrable and therefore, it is relevant and important to talk about a singular approach to cancer.
All of us understand the caveats associated with that. We understand that different cancers behave differently. That said, it's still worthwhile to talk about a redoubling of our efforts, a reinvestment in our approach to cancer, and now is the right time to do that.
Based on what we know right now about the Moonshot, what role will community oncologists play in this national effort?
It will be several fold. They will be participating in important clinical trials, such as TAPUR and NCI's MATCH. Community oncologists can refer their patients to those trials. We will see data-sharing consortia arise from this. All oncologists in the country will have an opportunity to participate in some form of data sharing consortia where, as appropriate, we're able to share genomic data from our patients.
It's interesting that you mentioned NCI-MATCH. I recently wrote about how investigators are figuring out how to best conduct that study. Initially, not all the study arms were open, and so there haven't been many matches [between patients and targeted treatment arms] for a variety of reasons. Still, the basket trial could be one way genomics impacts the way we do research. Are community oncologists eager to partake and what challenges do they have getting their patients on to these types of trials?
There has been an eagerness to participate, because oncologists everywhere recognize that there is a paradigm shift toward genomic profiling of patients followed by therapy against actionable mutations. So, oncologists across the country want to understand if that's a better approach. If it can help a patient, they want to have access to all the latest technologies and treatment approaches.
It's unfortunate that we have run into some problems with NCI-MATCH, where we didn't have quite enough arms open. I think the sequencing technology used has not identified as many actionable mutations. At the core of the uncertainty that some oncologists are facing, is: "I don't see my patients getting targeted therapy, or having actionable mutations identified. Are the actionable mutations really common enough in my typical patient population to warrant this type of testing and targeted therapy?"
Let's not jump to conclusions regarding the early hiccups in NCI-MATCH. Those will get smoothed out because of the leadership in place. We need to stay focused on the long-term goal, which is to use genomic testing, identify actionable mutations, and get patients on targeted therapy, and not get dissuaded by a few hiccups or speed bumps along the way.
How do cancer patients at Intermountain interface with genomic technologies? Do you have a process in place for screening all cancer patients or some of them? How do you decide that?
We have a precision genomics program at Intermountain Healthcare that focuses on performing genomic analysis on all patients with advanced disease, which we define as stage IV disease. So, any patient within our system that has metastatic or stage IV disease is offered this type of testing. We perform that testing in house, using technologies that are capable of seeing all of the relevant mutation types, which means that our chances of identifying an actionable mutation is very, very high.
The results from each patient's test are reviewed by a molecular tumor board that provides a consensus clinical interpretation. The ordering provider is then given those results and he or she is free to act in the patient's best interest, whether that's getting the patient on a clinical trial or obtaining a therapy outside of a trial. Ours is an end-to-end service that includes testing, the molecular tumor board, and we'll even help procure the drug for [patients], and monitor the results.
The growing number of genomic panels for tumor profiling, companion diagnostics approved with drugs, and now this new category of complementary diagnostics for guiding therapy, must present a challenge for community oncologists trying to figure out the best test to use for their patients. Intermountain provides an end-to-end service for oncologists, but to what extent is the growing number of test options a barrier to providing personalized medicine for oncologists in practices or health systems without such a service?
It's a challenge. There has been a proliferation of molecular diagnostics and not all of them are created equally. In fact, they are quite different in their capabilities and their sensitivities. And it's difficult for oncologists in the community, who have very busy schedules seeing and caring for patients, to try to decipher all these tests and wade through the differences and select one that's the best for their patients.
We will see a consolidation of these different tests that are out there. We will see formal recommendations coming from national committees. Then, it will be driven partly by where oncologists feel comfortable. If they can get a comprehensive service that includes testing and interpretation and even helps with procuring a drug, that's a more helpful service than performing a test, plopping a report on a provider's desk that they then have to try to interpret themselves and figure out how to use the information. That's too much. We have got to enable our oncologists who are on the front lines of providing treatment to patients, and provide them with as much information, help, and support as possible.
At Intermountain Healthcare, we recognized that for the most part many of these genomic tests, frankly, can read like Greek. It's difficult to interpret them. So, having a comprehensive service is really what enables the busy day-to-day community oncologist to implement genomics in to their daily practice.
Reimbursement is also one of the very time-consuming aspects of the job for physicians and their practices, especially when it involves comprehensive genomic profiling. How difficult is it right now for doctors to figure out if that testing will be covered for patients? Most payors are deciding whether to cover this kind of testing on a case-by-case basis.
Reimbursement is a topic of conversation that comes up a lot. Part of that is because it's in flux. The proliferation of genomic testing services has caused third-party payors to pause and think about how they should approach this new era. What gets reimbursed, what's the level of reimbursement, and what's the evidence behind these tests?
What I'm not seeing is a bunch of patients left with an out-of-pocket bill. I don't see that happening. At Intermountain, we work very closely with payors to make sure that we don't have patients who are left with a large bill. This will improve as additional evidence is generated, and as payors become comfortable with the value they're receiving for that test.
Another large, national project with an emphasis on genomics is the Precision Medicine Initiative. Has Intermountain figured out if it wants to be a healthcare provider organization that enrolls participants into this effort?
That initiative announced by President Obama in his 2015 State of the Union Address will provide a large amount of funding for seven large, integrated hospital systems, doesn't matter whether they are community health delivery networks or academic institutions. But the concept is to enroll a large number of patients for subsequent genomic testing and long-term outcomes analysis.
The way that has proceeded is that the institutions are submitting their grant applications right now. Intermountain Healthcare elected to submit its own application and we're submitting that today. There will be a lengthy selection process, and we expect to know later this year, whether we were one of the seven institutions that will be selected to participate in the Precision Medicine Initiative. Those selected institutions will be able to enroll patients in this large national trial, obtain blood for genomic analysis, and monitor long-term outcomes.