In 2016, the biotech billionaire Dr. Patrick Soon-Shiong set himself a deadline: By 2020, he would transform the fight against cancer.
With the help of a coalition of big-name companies, researchers, and physicians, Soon-Shiong vowed, he would enroll 20,000 cancer patients in clinical trials and develop an effective vaccine to treat the disease.
Four years later, independent medical researchers say they’ve heard virtual radio silence from Soon-Shiong’s initiative. And a review by STAT of clinical trial listings, research presentations, and press releases suggests the effort has fallen far short of its major goals.
Soon-Shiong and his team plan to “release results” next week related to his Cancer Breakthroughs 2020 initiative, according to his spokesperson, Jen Hodson. The announcement will take place during the J.P. Morgan Healthcare Conference in San Francisco — the same venue where Soon-Shiong unveiled the initiative in 2016, then called the Cancer MoonShot 2020.
Hodson declined to disclose details about plans for the presentation, or to answer questions more broadly about Soon-Shiong’s initiative.
Even so, there are signs that progress has been slow. The initiative appears to have signed up only a small fraction of the 20,000 patients it aspired to enroll in clinical trials, based on publicly available data. At most, it could conceivably hit about a quarter of that target. But it’s likely that the final number will come in dramatically lower once the trials that have not yet posted enrollment data publicly do so.
Several of the trials, testing various cancer vaccines that Soon-Shiong’s companies are developing, have reported preliminary results. But those results, while reasonably encouraging, are from small, early-stage safety studies with no control group for comparison. They are many steps removed from fulfilling the initiative’s goal “to develop an effective vaccine-based immunotherapy to combat cancer by 2020.”
It’s also not clear to what extent Soon-Shiong’s initiative is still active. The initiative’s website went dark this past spring, and its social media accounts haven’t been active in nearly three years. Its original Twitter account — abandoned after the initiative changed its name in 2017 — is now littered with dozens of posts promoting free Amazon gift cards. “#amazonfreegiftcard Coupon Code brings the precise latest amazon giftcard generation online step inside and get your Free Amazon Gift Cards Codes now,” the @Moonshot2020 Twitter account’s bio reads.
Soon-Shiong’s moonshot serves as a reminder of how ambitious promises in medicine can raise hopes and generate publicity — but often fail to result in meaningful progress for patients.
Dr. David Agus, an oncologist who directs the Lawrence J. Ellison Institute for Transformative Medicine at the University of Southern California, said he hasn’t “heard a thing, literally, about the results” since the initiative was launched.
“Every time someone offers [cancer patients] hope, and that hope isn’t realized, it’s almost a slap in the face,” Agus said. “And so when you’ve got someone like Patrick Soon-Shiong who sets out this aggressive agenda, and basically is promising hope, and then the cancer research community doesn’t hear anything at all, that’s really difficult. Cancer patients live by that hope.”
When Soon-Shiong first announced the initiative four years ago, he and his team issued a press release featuring glowing praise and words of optimism from prominent leaders in health care and business who would be teaming up with him to try to realize the moonshot’s goals. “An amazing opportunity,” said Dr. Vivian Lee, the head of the University of Utah’s health system at the time. “We will be able to make a significant leap,” said Columbia University medical oncologist Dr. Azra Raza.
By email or through their press representatives, STAT asked 17 of the leaders who were quoted in that press release to reflect on what the moonshot has and hasn’t accomplished in the past four years.
None of them agreed to comment.
One of the collaborating organizations listed in that press release, the University of Utah, returned STAT’s request for comment. The university was involved in early discussion about the coalition meant to power Soon-Shiong’s moonshot but “has not actively participated in any aspect of the effort since then,” a spokesperson said.
A history of splashy pledges
Soon-Shiong, 67, is a controversial figure in medicine, with a long history of making bold pronouncements and splashy pledges.
He made his name as a transplant surgeon, and in the early 1990s, seemed to suggest he had cured diabetes after he implanted a patient with insulin-secreting cells. But the results failed to hold up. Soon-Shiong made much of his fortune selling the pancreatic cancer drug he had invented, Abraxane. Today, Bloomberg estimates his wealth at $9.16 billion.
Soon-Shiong owns and runs a network of biotech companies under the umbrella of an organization called NantWorks. The most important are NantHealth, which sells software and diagnostic tests for cancer; NantKwest, which aims to harness immune cells known as natural killer cells to fight cancer; and ImmunityBio, which until last year was known as NantCell and is focused on developing a vaccine to treat cancer.
“Every time someone offers [cancer patients] hope, and that hope isn’t realized, it’s almost a slap in the face.”
Dr. David Agus
In the past two years, however, Soon-Shiong has attracted more attention as a steward of journalism than as one of science. In 2018, he bought the Los Angeles Times, rescuing it from a tumultuous period of cuts and uncertainty under the ownership of the media company now known as Tribune Publishing. Since the purchase, Soon-Shiong has earned plaudits for revitalizing the newspaper.
He is said to be a regular presence in the L.A. Times building, and last month he joined his newspaper’s editorial board for an interview with Bernie Sanders. Soon-Shiong asked the Democratic presidential candidate about how to save local journalism in an era of Google and Facebook; Sanders pitched the doctor on “Medicare for All.”
Soon-Shiong’s medical business, meanwhile, has struggled. A STAT investigation in 2017, a year after Soon-Shiong first launched his moonshot, found that the initiative was functioning largely as a marketing tool for NantHealth’s GPS Cancer test, which analyzes patients’ tumors and recommends a course of treatment.
Since then, NantHealth has struggled to get those tests paid for, and orders have dropped off, down to fewer than 50 tests in the third quarter of last year. Shares of NantHealth’s stock have been stuck mostly under a dollar in recent months, down from its initial public offering price of $14 in 2016.
Despite a modest surge in recent weeks, NantKwest’s stock price has been stuck around a dollar in recent months after the company went public in 2015 priced at $25 a share.
Next Tuesday morning, Soon-Shiong is scheduled to present at the J.P. Morgan conference on behalf of ImmunityBio, which is privately held.
The venue is a high-profile opportunity for Soon-Siong to lay out his vision to top investors, and it may be where he chooses to unveil results from the moonshot initiative. On Tuesday, Soon-Shiong tweeted that he would soon be providing updates on the initiative’s progress in cancers of the breast, lung, bladder, pancreas, and head and neck.
Will soon be explaining my theory of the triangle offense for cancer. And why it works. And the update of cancer breakthrough 2020 in multiple cancers ..breast, lung, bladder, pancreas, head and neck, all with nature’s killer cell born to kill . Over trillion cells given safely.
— Dr. Pat Soon-Shiong (@DrPatSoonShiong) January 7, 2020
It’s certainly possible that Soon-Shiong could unveil significant new clinical results, but there haven’t been any signs that something groundbreaking is coming. And Agus isn’t holding his breath.
“One doesn’t release cancer data and cancer results at the J.P. Morgan conference,” Agus said. “One does it at AACR, or ASCO, or one of the peer-reviewed conferences that really matter. That’s where you move the needle.”
An initiative’s engine sputters
In 2016 at the J.P. Morgan conference, Soon-Shiong took the stage to unveil what was billed as “a four-year-long race to subdue cancer by the start of the next decade.”
Before a crowded room of biotech investors and executives, he played several emotional patient videos. And he didn’t hold back in describing the potential of his initiative. “Sometimes some people do things,” he mused at one point, “and it creates exponential change in mankind.” At another point, he turned to one of the leaders in business and health care flanking him on stage: Daniel Hilferty, CEO of the parent company of the health insurer Independence Blue Cross, which was to collaborate with him on the moonshot. “When I say to him: ‘Dan, you’re going to be responsible for the cure for cancer’ — I am very serious about that,” Soon-Shiong said.
In calling his initiative a moonshot, Soon-Shiong was piggybacking on a separate and much higher-profile moonshot to fight cancer — the one launched by then-Vice President Joe Biden just a few months earlier. His moonshot was largely well-regarded, not least for steering clear of predicting the end of cancer by a certain date, before it shut down last summer. (The University of Texas’s MD Anderson Cancer Center has yet another, even older, moonshot program, started around 2013.)
The crucial engine of Soon-Shiong’s moonshot was to be its clinical trials program, known as QUILT.
His spokesperson declined to say how many patients have been enrolled in QUILT trials so far. But a STAT analysis of the 64 QUILT trials listed on the federal registry clinicaltrials.gov makes clear that the program has fallen far short of its goal of enrolling 20,000 patients.
Forty-one of the trials have reported their final enrollment numbers; all told, those studies have enrolled 2,054 patients. But half of those patients were enrolled in QUILT studies that were shut down early, either for administrative reasons or because the researchers determined that the treatment wouldn’t work. Another 769 of those patients were enrolled in studies that wrapped up between 2011 and 2015 — in many cases years before the moonshot initiative was even dreamed up.
Only 233 patients have been enrolled in QUILT trials that were carried out in full and were completed after the moonshot’s launch.
There are 23 QUILT trials that have not yet reported final enrollment numbers. These studies are active, so some of them are still recruiting patients. All of them have reported “estimated” enrollment targets — representing the number of patients they hope to eventually enroll. Collectively, the “estimated” enrollment targets of these ongoing QUILT trials add up to 3,096 patients. (Judging from typical patterns in clinical research, many of these studies will fall far short of these targets, while a rare few may surpass them.)
“When they start ascribing percentages when there’s nine patients, and they say there’s a 67% overall response rate? That’s ludicrous.”
Dr. Eric Topol
Even assuming all of those slots have been filled, the QUILT trials program has enrolled no more than around 5,000 patients to date. The actual number is almost certainly far lower.
The QUILT trials program has also been central to Soon-Shiong’s quest to develop a vaccine to treat cancer — a longtime “dream in the cancer space,” as Agus puts it.
The problem? Therapeutic vaccines “have yet to work,” Agus said. “There have been tens of thousands of patients put on clinical trials for therapeutic vaccines and none have really shown any long-term consistent benefit.”
One of Soon-Shiong’s QUILT trials, a single-arm safety study in advanced pancreatic cancer, tested several vaccines that his companies are developing. Soon-Shiong and his team reported in November 2018 that 10 patients got the vaccines along with a cocktail of other treatments. The patients experienced side effects, though they were likely caused by chemotherapy — an encouraging sign for the safety profile of the experimental treatments included in the cocktail. Nine of the patients saw their disease stay stable for at least two months, but just three of them were still alive when the results were reported.
Last month, Soon-Shiong’s researchers reported results from another single-arm safety study in the QUILT program, this time in patients with an aggressive form of breast cancer. Nine patients got experimental vaccines along as part of a cocktail of other treatments. There were side effects, but they didn’t appear to be related to the vaccine components of the cocktail. Four of the patients saw their disease respond partially, and two of them saw a complete response; those responses lasted between two months to over a year.
Dr. Eric Topol, a geneticist who directs the Scripps Research Translational Institute, called the studies “not very impressive” and “not significant contributions,” because their enrollment numbers are so small. “When they start ascribing percentages when there’s nine patients, and they say there’s a 67% overall response rate? That’s ludicrous,” Topol said.
Topol said he sees Soon-Shiong’s moonshot as the latest chapter in a “long history of extraordinary hyperbole in cancer.” He pointed back to 2003, when the director of the National Cancer Institute at the time, Andrew von Eschenbach, set a deadline of 2015 to “eliminate death and suffering” from cancer. That never happened, of course, and nearly 600,000 Americans died from cancer in 2015.
“So many times we’ve seen this, not just from Patrick Soon-Shiong,” Topol said. “These pronouncements are made, and they’re never fulfilled. Never. This is just one more.”
“How many times do we need to learn that lesson?”