CHICAGO – Massive Bio last week introduced an ambitious plan to apply artificial intelligence to improve clinical trial matching for cancer patients.
The New York-based bioinformatics company said that it wants to get 100,000 people into clinical trials to accelerate research and improve outcomes for cancer patients worldwide through what it has named the 100K Cancer Clinical Trial Singularity Program.
"Singularity" is a term in the technology world describing a hypothetical future state where the convergence of transcendent technologies creates a new reality.
"We are trying to use this thing [to create] exponential change from where we are currently located," said Selin Kurnaz, Massive Bio's cofounder and CEO. "In order to be able to get to large enrollment rates, you cannot do the same thing and expect different results."
The primary goal for the program is for Massive Bio to "get access" to patients newly diagnosed with an advanced-stage cancer as early as possible to identify trial options and then provide individuals and their oncologists with the information they need to make an informed decision on whether to enroll, according to Kurnaz. "The earlier that you catch those patients [and] start the education and awareness on the clinical trials, the better you get in terms of outcomes," he said.
Kurnaz said that the program is Massive Bio's way of rethinking trial recruitment. "We're bringing an engineering level of a solution to a clinical research problem, as opposed to a clinical research level of a solution to a clinical research problem," he said.
"There is a gap in the system," Kurnaz added. In this new program, Massive Bio wants to interact with newly diagnosed patients to get them sequenced and educate them on clinical trials, while also coordinating workflow between next-generation sequencing labs and community-based oncologists.
Massive Bio is not the only company trying to solve the problem.
Digital health startup TrialJectory recently found through a survey of US cancer patients that while most understood the importance of using genetic testing to guide treatment decisions, less than half had undergone NGS testing to identify actionable biomarkers during the course of their treatment. That firm has been exploring partnerships with diagnostics firms and other strategies to help patients get access to NGS testing.
Another startup, Science 37, is helping Roche and its cancer genomics testing subsidiary Foundation Medicine enroll patients in trials, while Eli Lilly has contracted with a company called Care Access for similar services.
Since 2018, Massive Bio has been building a global registry for clinical trial matching, called Synergy-AI, which applies AI to match patients based on genomic biomarkers and multivariate analyses. Earlier this year, Massive Bio introduced what it calls a "NASA-style" command center for rapid oncology clinical trial activation and patient enrollment.
Massive Bio has a patient contact center for direct acquisition of trial candidates, and also identifies patients through cancer centers, physician practices, NGS vendors, specialty pharmacies, and payor prior authorization units.
The 100K Cancer Clinical Trial Singularity Program seeks to take those services and technology to another level and concentrate on a specific goal, though Kurnaz called 100,000 an arbitrary number. Kurnaz anticipates reaching the goal in the next two years. Massive Bio, which has operations in 12 countries and expects to add seven more by the end of 2022, will be recruiting globally.
Kurnaz said that Massive Bio likes to talk about the "'Amazonization' of the patient enrollment value chain," meaning the large-scale automation of data and intelligence flow behind the scenes to present a seamless user experience on the front end. "This program is one way … to show that scale and efficiency to the world of clinical research."
A widely cited 2016 study from the American Society of Clinical Oncology found that fewer than 5 percent of adult cancer patients enroll in clinical trials related to their cancers even though closer to 20 percent are eligible.
"It's not like that you enroll 20 percent of the patients overnight," Kurnaz said. "But what I believe is that some crazy people like us has to say this is doable."
The program initially will include cervical, breast, prostate, gastric, gastroesophageal junction, and pancreatic cancer, plus non-Hodgkin lymphoma, myelofibrosis, tumors of the central nervous system, melanoma, multiple myeloma, and various pediatric tumors.
According to Kurnaz, it is important for Massive Bio to specialize in oncology, particularly at community-based cancer centers and clinics, which need the most support and do not always have relationships with molecular laboratories.
Arturo Loaiza-Bonilla, cofounder and CMO, said via email that the 100K Cancer Clinical Trial Singularity Program is meant to connect patients in need of NGS biomarker testing with sequencing labs as well as to match those individuals to genomically driven clinical trials. Loaiza-Bonilla said that Massive Bio is coordinating with Foundation Medicine through that firm's SmartTrials research service and also has relationships with companies including Guardant Health, NeoGenomics, and Caris Life Sciences to coordinate information exchange.
If a patient has already been sequenced and has consented to join a trial pool, Massive Bio is able to go to the molecular lab and retrieve test results electronically, then integrate that data into the trial prescreening process, according to Kurnaz. For patients who have not yet been tested, the firm can offer them options for local NGS service providers.
"A lot of the practices in the community may not necessarily have the right workflow in order for these patients to get tested," Kurnaz said. "The next-generation sequencing workflow is an important part of our strategy in that sense."
The Massive Bio CEO said that his company is not compensated to prefer one NGS vendor over another.
Without the right biomarker and clinical data, healthcare providers could end up with a dozen or two possible trial options from ClinicalTrials.gov, with no good mechanism for figuring out which is most appropriate, according to Kurnaz. ClinicalTrials.gov is a static database, though, often months behind the reality of the research the site lists.
Massive Bio uses its prescreening data to help narrow down lists like that and present to the treating oncologist and the patient a more manageable list of the most appropriate options. Patients, of course, are under no obligation to enroll, but the company wants to make sure they make informed decisions.
Kurnaz said that Massive Bio has identified 33,000 patients to date through its contact center, which does not count those added through provider and other enterprise channels. However, he noted that timeliness of patient access is at least as important as volume; trial sponsors want patients who are actively receiving cancer treatment.
Kurnaz said that Massive Bio is trying to position itself as a hub for trial matchmaking; he has seen many cases where multiple contract research organizations have come to the firm to help fill the same clinical trial. The company is looking to ramp up recruitment by forming partnerships with the likes of patient advocacy groups, payors, and specialty pharmacies, while hoping to avoid numerous pitfalls
A landmark 2017 study from Memorial Sloan Kettering Cancer Center found that about 37 percent of patients tested had clinically actionable mutations in their cancers, but, according to Neha Jain, a cancer genomics researcher at Vanderbilt University Medical Center, many of those mutations do not meet US Food and Drug Administration criteria for immediate immunotherapy trial enrollment, so there needs to be additional eligibility evidence available from nonmolecular sources.
Jain was first author of a study published earlier this year in the Journal of Clinical Oncology: Clinical Cancer Informatics that found that algorithms using only patients' diagnosis and next-generation sequencing data to match them to clinical trials resulted in false-positive matches 88 percent of the time. These false positives were most commonly the result of delayed and disjointed information sharing about the trials' arm-specific enrollment status.
Jain called Massive Bio's collaboration aspect to collect information about which trials actually have openings "probably very important" to reduce false positives, but said it was only a first step because trial enrollment is like trying to hit a moving target. "If there's a new, adjuvant trial, there's a very small window of time when you would be eligible for it as a patient," she noted.
While there are many efforts to improve trial matching that rely on AI, Jain said that the 100K Cancer Clinical Trial Singularity Program stands out because it is large and ambitious.
However, for an effort like this to be successful, according to Jain, it not only has to find the right patients and have a "very good patient data model," a technology system needs to be able to parse clinical trial documents that are not always machine-readable. The last part might require the US National Cancer Institute or other grant-making body to standardize language on submission forms.
Jain would also like to see NCI remove some of the redundancy in trials. "If we have this problem that we are not able to fill up all our trials, is it intelligent to have so many competing trials open?" she wondered.