Cambridge biotech’s cancer test turns out to be a ‘lifesaver’
CAMBRIDGE — John White, a retired North Attleborough bioengineer, was diagnosed in early 2015 with aggressive prostate cancer. It had spread to his bladder and pelvic lymph nodes. It didn’t respond to hormone therapy and chemotherapy. His oncologist feared White might have only a year to live.
Then scientists at Foundation Medicine, a Cambridge biotech, ran a new diagnostic test to sequence the DNA of cancer cells in his prostate gland, which had been surgically removed. The bad news was that he had a rare form of the disease, marked by an extraordinary number of genetic changes in the cancerous cells. The good news: The new test showed that he might respond to any of three new immunotherapy drugs.
In August 2016 White began taking one of those drugs, Keytruda, sold by Merck & Co., which had been approved to treat several forms of cancer, although not prostate tumors. It worked. His cancer soon began to shrink. Two years later there’s no evidence of the disease. His oncologist wrote about the case in a medical journal and recently said his patient wouldn’t be alive if Foundation’s test hadn’t so swiftly guided him to the right medicine.
“That’s not hyperbole,” said Dr. Paul Mathew, of Tufts Medical Center. “I cannot think of another strategy I would have had in hand to control the disease so it didn’t take his life.”
White, 63, was no less effusive about Foundation’s test, which detects mutations in 324 genes in solid tumor samples and lists potential drugs to treat the cancer.
“It’s been a lifesaver to me,” he said. “I was only given months to live four years ago, and here I am still thriving.”
The Food and Drug Administration approved the test, called FoundationOne CDx, last November, marking a breakthrough in the era of personalized cancer medicine.
The test yields a detailed report that lists the genomic features of tumors in patients with advanced cancer as well as medicines, approved or in clinical trials, that could treat it — all within about two weeks.
The FDA’s approval has stoked growth at Foundation, which was started in 2010. FoundationOne CDx is the flagship of three genomic profiling tests developed by the company, and it’s far and away the most widely used. Doctors have recommended Foundation’s tests to patients 80,000 to 100,000 times this year, according to a Foundation spokeswoman, and FoundationOne CDx accounted for over three-quarters of them.
Over the past year, Foundation’s work force has grown by about half, from about 600 employees to 900, according to Dr. Vincent Miller, its chief medical officer. Miller said he expected similar growth this coming year.
In addition to its headquarters and laboratory in Cambridge, Foundation has a lab in North Carolina’s Research Triangle, Switzerland, and Germany. But most of the growth is in Cambridge, said the company spokeswoman.
A key driver of the expansion was the federal government’s decision in March to cover the cost of the FoundationOne CDx test for patients enrolled in Medicare, the national health insurance program for people 65 or older. That made it affordable for many more patients, each of whom would have had to otherwise payseveral thousand dollars.
Standing behind Foundation is one of the world’s largest drug companies. Roche, the 122-year-old Swiss multinational, owned about 57percent of Foundation’s common stock and bought the rest of the firm in June for $2.4 billion.
Roche has made a big bet on Foundation’s approach to precision medicine, one that dovetails with Roche’s broad portfolio of approved and experimental cancer drugs.
The pharmaceutical giant has about 20 cancer drugs on the market and roughly another 40 being tested in patients, according to Daniel O’Day, chief executive of Roche Pharmaceuticals. Some of those medicines will undoubtedly end up being suggested as a potential treatment in a FoundationOne CDx report.
Nonetheless, said O’Day, the report will list whatever treatment would appear to work best, regardless of which company makes it.
“They’re agnostic to Roche,” O’Day said of Foundation’s reports, in an interview. “It just so happens that we have a lot of [cancer] medicines.”
With a sales force in 130 countries, Roche has also expanded Foundation’s international marketing efforts.
Big companies often promise a hands-off approach when they buy up-and-coming startups — promises that are soon broken. But O’Day said Roche is committed to maintaining Foundation’s independence. Roche made a similar commitment when it bought the oncology-focused electronic health records firm Flatiron Health in New York for $1.9 billion in April this year.
Foundation will keep its name and leadership team, O’Day said. And he will have access only to information relevant to Roche, not about Foundation’s partnerships with over 50 biopharma companies that use the firm’s genomic sequencing database to develop drugs.
What Roche wants most from Foundation, O’Day said, is to continue developing genomic tests to guide cancer patients — and to develop them even faster.
“What we want them to do is to take their five-year plan and achieve it in three years,” O’Day said.
If John White — the North Attleborough retiree whose prostate cancer is in remission — is any gauge, patients would welcome that, too.
White had feared that he wouldn’t be able to attend the wedding of his daughter, Hillary, in May.
But as a result of the Keytruda infusions, he not only attended the wedding at a church in Newport, R.I., he walked her down the aisle.
Among the guests were Mathew, his Tufts oncologist, and two Tufts nurses who helped care for White.
“To see him walk with his daughter down the aisle — I cannot describe the feeling,” Mathew said.
For White it was easy to describe his own feelings: “It was a thrill.”