This is the online edition of ESMO in 30 Seconds, a pop-up newsletter from the European Society for Medical Oncology’s annual meeting in Barcelona, Spain. There are no more editions this year, but you can keep up with biopharma news by signing up for STAT’s The Readout newsletter.
A status check on immunotherapies
It was 10 years ago that Keytruda and Opdivo were approved in their first indications. One of the pervading themes of this year’s ESMO was a reflection on all that the drugs have done, and all that immunotherapy still needs to achieve.
The conference included a decade’s worth of data from some of the early Keytruda and Opdivo trials, with the takeaway being that roughly 50% of patients with metastatic melanoma will now survive over the long term.
It’s a major change in cancer care, and immunotherapies keep finding success in new indications. But researchers at the conference, while celebrating the progress, also noted the range of challenges that remain, from tumor types that evade treatment to a lack of tools that could help determine how to use the drugs in smarter ways.
Here’s our ESMO wrap-up on what we learned about the status of immunotherapies.
‘The future is here’
Another theme featured at ESMO this year centered on how quickly and profoundly AI has already changed — and will further change — oncology.
“The future is here in terms of digital pathology and in terms of using artificial intelligence tools to help and guide us to a better, refined diagnosis,” Federica Di Nicolantonio of the University of Torino said at a press conference, in just one example of researchers discussing how AI was shaping care.
But how can regulators keep up? And how can clinicians know that the new tools they have access to will work for their patients?
Amy Abernethy, the former FDA official and former Verily exec, addressed that topic in a keynote over the weekend.
“When I was at FDA, there were several hundred AI algorithms that had been cleared” in the U.S., she said. “These days, there’s nearly a thousand, and that number is increasing 30% year over year, just for the regulatory-cleared algorithms.”
Abernethy argued that regulators need to ensure that algorithms are relying on high-quality data, that they work at the point of caring for a patient in a clinic, and that they continue to perform well over time.
But with algorithms arriving fast and furious, “we have to have a way to evaluate performance at scale,” she said.
For more on Abernethy’s latest endeavor, check out my colleague Matt Herper’s story from last week.
Researchers need to change their habits to figure out why cancer incidence under 50 is on the rise
We’ve mostly been focused on clinical trials at ESMO, but one of the thorniest problems the field is facing is one of epidemiology — the major increase in incidence of certain cancers in people under age 50.
The issue is almost certainly multi-factorial, and likely touches on hard-to-study issues like diet and environment.
But in another keynote, Shuji Ogino, the chief of molecular pathological epidemiology at Boston’s Brigham and Women’s Hospital, raised one problem that is getting in the way of researchers’ efforts to understand the causes.
Essentially, even if people develop cancer in their 30s, perhaps the roots of their disease go all the way back to their childhood. But researchers specializing in pediatric issues and those focused on adult health don’t usually work together, Ogino said.
“We don’t talk to pediatric researchers,” he said. And pediatric experts in turn “lose interest when children become adults. Their interest is childhood outcomes, or maybe young adult outcomes — not old enough to get cancer.”
Ogino added: “We just have a big gap. If we can connect this, I think we can address a big problem.”
Can more aggressive treatment prevent cancer surgeries? And is that a good thing?
The conference’s final presidential session this afternoon focused on studies that touch on the burgeoning issues oncology will be facing going forward, from tumor-agnostic trials to the use of AI, from immunotherapy resistance to epigenetic targeting in cancer treatment.
There was also the topic of organ preservation. That is, in cancers where surgery is often used, can you boost the pre-surgery treatment regimen so that patients can avoid undergoing these procedures?
The presented study focused on rectal cancer, and found that by amplifying the initial treatment, about one in four patients had complete responses, meaning they didn’t have any tumor left to remove with surgery. There wasn’t an impact on long-term outcomes.
The trial was dubbed the “NO-CUT” study.
Such an approach could have major benefits for patients’ quality of life. The rectal surgery requires removing at least part of the bowel, which can affect its function or even require colostomy.
David Sebag-Montefiore of the University of Leeds, who was the discussant at the session, noted at a press conference previewing the research that the use of treatments like chemotherapy and radiation to avoid surgery come with their own side effects that need to be considered. But, he said, those effects “may be significantly less for the majority of patients” than needing to undergo surgery to remove part of the rectum, saying in the session doctors were trying to offer “smarter, kinder” care.
He said it’s possible that, with immunotherapies or other next-generation treatments, doctors could boost the rate of patients who see complete responses without surgery to perhaps 60%.
“We’re entering an era where that paradigm of radical surgery is beginning to be challenged with a new approach,” he said. There is emerging evidence, in a number of cancers, “that those complete responses are increasingly durable, and those who obtain it, with close active surveillance, the majority may avoid radical surgery all together.”
Fabrice André, a French oncologist who chaired today’s presidential session, told reporters that organ preservation was an issue in a range of tumor types, including lung and breast cancer. But he also said that the side effects that can come with more aggressive drug regimens need to be considered.
“It is very, very important — if we can go to organ preservation, that has to be associated with a formal assessment of the improvement of quality of life,” he said. “Organ preservation itself is not the endpoint. The endpoint is improving the quality of life of the patient.”
Exact Sciences reports early positive results in colon cancer blood test
A blood-based test from Exact Sciences showed potential in accurately detecting colon cancer, according to new research presented at ESMO.
While the initial results suggest that Exact’s test could be a competitive alternative to others already on the market, the findings come from a small study intended to help the biotech refine the algorithms and biomarkers powering the test. A larger and more definitive study is underway.
But the results certainly got the attention of AmirAli Talasaz, co-founder and co-CEO of Guardant Health, which sells a rival blood-based screening test.
“Kevin Conroy, I’ll publicly bet you $1M that your [advanced adenoma and colorectal cancer] data at ESMO (whatever the readout) won’t hold up in your pivotal trial,” Talasaz wrote in a weekend LinkedIn post published prior to Exact’s announcement and addressed to its CEO.
My colleague Jonathan Wosen explains more in this story.
What we’ve been reading today
Thanks for reading! – Drew