“desperate” situations: “We don’t profile [a tumor] for [hundreds] of genes, we profile it for what’s relevant to that tumor type and to those approved agents. And all of that other noise, I don’t know what it means.”
This signal-versus-noise issue is one Foundation is trying to counter. It has given presentations at medical meetings containing anecdotes, like when FoundationOne spotted a type of “ALK fusion” mutation that other tests had missed in a 19-year-old female lung cancer patient. Her prior treatment had failed and she was basically preparing to die in a hospice. Instead, she was given the ALK-targeting drug crizotinib (Xalkori) and was discharged from hospice in five days.
At this point, however, the anecdotes need to turn into data.
“While we do believe providers (and payers) increasingly want more comprehensive evidence of practical utility, we expect this evidence to build over time,” Leerink Partners analyst Dan Leonard wrote after a major medical conference last year.
What type of evidence would sway a skeptic like Monk? “A randomized clinical trial,” he says.
Foundation began running such a trial with the University of Texas MD Anderson Cancer Center in August. The goal: to see whether targeted drugs, identified through broad molecular profiling, will provide patients a clinical benefit. Specifically, Foundation and MD Anderson hope to keep tumors in check longer (what’s known as progression-free survival) in patients with advanced disease. It’s also hoping that Roche will help sway the skeptics through its relationships with the medical community.
But Foundation also isn’t actually providing anything inherently proprietary, making Roche’s zeal to forge a massive alliance with the company both risky, and a huge endorsement in the value of its early-mover advantage and ability to build on it going forward.
It’s unclear how Foundation will defend its business if, say, Illumina continues its push into molecular profiling and throws some of its billions of dollars behind the pan-cancer tests that Foundation offers. The threat is real. Illumina has already teamed with AstraZeneca, Sanofi, and Johnson & Johnson to develop what it calls a “comprehensive tool for precision medicine”—a diagnostic used to test people for dozens of genetic drivers for cancer.
Here’s another scenario: What if billionaire Patrick Soon-Shiong’s NantWorks achieves its ambitions of essentially bringing the entire tumor profiling and analysis process into the point-of-care setting?
Pellini counters that so-called “hotspot panels” (such as the one Illumina is developing with the three pharma companies, which target groups of the most relevant genetic abnormalities) aren’t actually direct competitors—he views them as “complementary.” He argues, for instance, a hotspot test would work well in early-stage disease, when a patient has more time, and a less expensive, narrower test would be more reasonable.
Foundation isn’t focusing there. Rather, it’s mapped out six areas where it thinks its tests are most viable. Those are: metastatic non-small cell lung cancer (“all the different pieces you would find that you would not pick up with a hotspot-based test,” Pellini said); cancer of unknown primary, where patients already undergo a bunch of tests to find out where their cancer originated; rare to uncommon tumors, for which there is typically no standard molecular testing, and patients are often subjected to broad chemotherapies; more aggressive cancers (pancreatic, for one), where there isn’t much time to do more than one test; patients with metastatic disease who have failed multiple treatments; and when there isn’t enough tissue from a sample to do the appropriate testing.
All told, Pellini said these groups add up to anywhere from 800,000 to 1 million patients a year in the U.S. alone.
And while Pellini said it’s “reasonable” that a competitor could have technology similar to FoundationOne on the market in the next few years, he believes it will be too late. “At that point, we’ll have been in the market for five years. Think of the database we will have, think of the relationships we will have with the community oncologists as well as the academic oncologists,” he said. “Don’t you still have to dislodge the relationship Foundation has with its clients?”
Pellini added that the Foundation of three years from now will be a different company, with a bigger database, more products, and more information incorporated into the tests it already offers.
He noted efforts to look into liquid biopsies, or apply what Foundation is doing to cell-free DNA or circulating tumor cells; or to incorporate markers for immunotherapies into FoundationOne.
Roche today is clearly betting Pellini is right. By acquiring shares at such a premium, the Swiss giant is not only betting on Foundation’s utility as a research tool—its partnerships with pharmaceutical companies, after all, do account for some 60 percent of its revenue—but that it really can make a dent on the clinical side, and become a mainstay in cancer care. Can it get there? Roche’s endorsement goes a long way, but payers, and doctors on the front lines, will ultimately decide.
“By combining [Foundation’s] pioneering approach to genomics and molecular information with Roche’s expertise in the field of oncology, we can bring personalized healthcare in oncology to the next level,” Roche’s O’Day said in a statement.
Alex Lash contributed to this report.
