A pair of studies Illumina researchers presented at the American Society of Clinical Oncology’s annual meeting in Chicago this weekend generated a feeling of whiplash: While one showed that using comprehensive genomic profiling (CGP) to guide treatment decisions can significantly improve outcomes for cancer patients, the other confirmed that between 50% and 80% of eligible insured patients don’t actually receive the recommended tests.
Taken together, the studies highlight the urgent need “to democratize genomic profiling in cancer,” a core tenet at Illumina, according to Kevin Keegan, a vice president at the company and general manager of its oncology business.
“Our data show that an enormous and even alarming number of patients are not getting genomic profiling when they get diagnosed,” he said in an interview with Fierce Medtech on Friday.
“There are massive gaps; there are still unmet needs. Even here in the U.S., where we have probably more genomic medicine being used than anywhere else, there are still just massive, underserved populations in this country,” Keegan continued. “That’s one of the most important things that we have to wrestle to the ground.”
Typically, he explained, after a patient is diagnosed with cancer, the plan of attack begins with surgery to remove the identified tumor.
“For patients with localized cancer, surgery will cover it. But if you miss the margins or the spread or the metastatic disease, then you have a serious problem, because it’s no longer treatable with surgery. And now you need to understand how to treat it,” he said. “A lot of these patients just get blasted with chemo—and chemo works, and it helps—but if you can identify it in a targeted way to treat it, the outcomes are vastly better. And so this is what we’re missing here.”
Indeed, combining CGP like that offered by Illumina’s tests with targeted therapies—“identifying what is causing the cancer and treating it in a precise way”—makes for a “one-two punch” resulting in more efficient cancer treatment, Keegan said.
The outcomes-focused study saw Illumina partner with the Providence Health Network and set up a reflex testing protocol that automatically ordered no-cost CGP testing for patients as soon as they were diagnosed with advanced cases of cancer.
Of the more than 1,400 patients who were included in the study—in whom the most common diagnoses were non-small cell lung cancer, colorectal cancer and breast cancer—the tests found actionable biomarkers in almost half. Only a sliver of those patients were then treated solely with chemotherapy—undergoing regimens of targeted therapies, immunotherapies and other combination approaches instead—while nearly two-thirds of those without actionable biomarkers did undergo chemo-only regimens.
By the end of the study, which followed the patients for at least a year, one-year survival rates for the chemo-only group clocked in at just under 63%, compared to more than 70% for all of the patients treated with targeted therapies—whether they were biomarker-matched. In total, median survival for the two groups came in at 17 months and 25 months, respectively.
Ultimately, the study proved that with a targeted-therapy approach to cancer treatment—which becomes easier to select when relying on CGP test findings—“the outcomes are vastly better than using chemo or radiation,” Keegan said, adding, “So if you don’t do broad-based genomic testing, you miss important, life-saving targeted therapies.”
As for filling in the gap between the patients who should be receiving CGP testing and those who actually do, the Illumina exec was quick to highlight the company's choice of venue for the study: Providence is a standard community hospital system like those where most cancer patients receive care, he noted—in contrast to “state-of-the-art” facilities like the Mayo Clinics and MD Andersons of the world—and the study proved that routine CGP tests can be easily implemented into the standard of care at any institution.
“Patients who are treated every day in these institutions that are not MD Anderson, they still need the same type of testing and treatment,” Keegan said. “So, we distribute tests all over the world that enable them to do that in their hospitals, in their community centers and in their health systems.”