By Deborah Borfitz 

September 15, 2021 | Cancer-gene profiling company Foundation Medicine has teamed up with decentralized clinical trial specialist Science 37 to enable home-based clinical trials in oncology. The pilot project with Roche employing this model, launched last December, seeks to learn if alectinib (Alecensa) would be clinically useful for patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic solid tumors outside of the lung, according to Foundation Medicine CEO Brian Alexander, M.D.  

Alectinib is already approved in dozens of countries for treating people with ALK-positive non-small cell lung cancer, which accounts for about 4% of all lung cancers. It is a particularly rare genetic alteration across other tumor types, says Alexander, highlighting the value of Foundation Medicine’s molecular information knowledgebase containing genomic information on more than 500,000 patients globally whose tumors have been profiled. 

While Foundation Medicine is an independent subsidiary of Roche, it is “a bit of a coincidence” that the biotech company is the first industry partner to move beyond the dabbling phase with the decentralized research approach, Alexander says. “It was a nice dovetailing of interests at the right time… Roche was looking to see if this drug worked in patients without non-small cell lung cancer that had these ALK-driven alterations, and we were thinking about ways to identify this rare population.”  

Only about 50 patients are expected to enroll in the ALPHA-T trial, which concludes in December 2025.   

Although Foundation Medicine has previously engaged in efforts to expand access to clinical trials—including just-in-time enrollment into large, research-ready practices and projects with Flatiron Health and OneOncology—this is its “first foray” into completely decentralized clinical trials, says Alexander. 

The company has over 60 big pharma partnerships for evidence generation work, including identifying patients for trials as well as developing disease biomarkers, he says. All of them are interested in seeing greater participation in clinical trials among cancer patients—only 1 in 20 do so currently—and the decentralized approach holds promise for opening the spigot by improving access to studies.  

“We’ve been identifying the patients,” says Alexander. “Now, we are trying to democratize the opportunities that [genomic profiling] information unlocks.”  

The company sequences the genome of about 2,500 cancer patients on a weekly basis, he notes, and has a SmartTrials program to identify trials for which they would be a match. The Science 37 collaboration is now endeavoring to make participation a realistic option for patients by “bringing the trial to them rather than have them travel to the trial.”  

Distance Factor 

Many patients for which Foundation Medicine performs testing don’t necessarily live near the site where an identified clinical trial is being conducted. A 2018 study published in The Oncologist (DOI: 10.1634/theoncologist.2017-0628) found that the median unidirectional distance traveled among patients enrolled in cancer clinical trials was just over 25 miles and the situation was even worse for participants in trials sponsored by the National Institutes of Health.   

Patients with rare cancers, and fewer options, may live hundreds of miles from a relevant study site, says Alexander. The distance factor could be mitigated by conducting study visits virtually, provided would-be participants reside in the same state as their telemedicine investigator. 

Licensure laws effectively bar study investigators from crossing state boundaries, an issue that can be managed by using a separate licensed investigator in each state where the clinical trial is being conducted. The broad investigator network of Science 37 is allowing access to the wholly decentralized alectinib trial to patients across nine states, Alexander says, facilitated by relationships Foundation Medicine has in the oncology space.    

Expansion to other states is expected, he adds, both by adding more investigators and having active ones apply for licenses in other states.  

“We’re working with investigators … to make the trial apparatus more lightweight for patients and doctors who order [genomic] testing in the first place,” he continues. The pandemic has forced everyone—from the Food and Drug Administration (FDA) to sponsors and patients enrolling in trials—to think about ways to decentralize the research process as well as heightened the “sense of urgency” in drug development across the board.  

Clinical Care ‘Supplement’  

For the home-based clinical trial now underway, Science 37 is providing a network of mobile nurses and at-home connected devices in addition to the telemedicine investigators, Alexander says. Foundation Medicine is identifying patients who may be eligible based on their genomic test results. 

Recruitment happens primarily through manual outreach to ordering physicians to alert them to the trial opportunity, he adds, which is the standard process. The only change is that patients don’t have to go anywhere to participate.   

When Foundation Medicine launched in 2010, it was almost unthinkable that comprehensive genomic profiling would become accessible as part of routine clinical care, says Alexander. Sequencing like that was expensive and only happened in a research context, including programs such as the Cancer Genome Atlas, and “results weren’t contextualized so they were meaningful for patient care.”  

Now, in addition to enabling better decision-making, Foundation Medicine wants to help ensure patients and their physicians can act on those decisions. “We’re still in the pilot, but the intention is to have oncologists very much engaged in the study,” he says.  

In an ideal world, patients’ regular treating physician would become an investigator on the study. The reality is they rarely have the time given all the bureaucratic requirements, says Alexander, so the next best alternative is to supplement the care they provide locally with telehealth.  

Many barriers will need to be overcome for home-based clinical trials to take off to any significant degree, regardless of how well the ALPHA-T study goes, says Alexander. Much of it comes down to “working within the [regulatory] constraints that exist” to make a decentralized trial as seamless as possible for doctors and their patients.  

The FDA, given its interest in making trials more patient-centric, seems to favor the decentralized model conceptually. A few years ago, Alexander joined Science 37 CMO Jonathan Cotliar for a panel discussion on decentralized trials at an Accelerating Anticancer Agent Development and Validation Workshop co-sponsored by the FDA.  

Separately, Foundation Medicine is interested in investigating whether there are any disparities in terms of access to ordering or getting reimbursed for its tumor profiling tests, he says. If so, that could in turn be limiting access to oncology clinical trials—virtual or otherwise—as a treatment option.