Biogen Inc and Eisai Co caused a stir in September when they announced positive results in a late-stage trial for a closely watched Alzheimer’s drug, lecanemab. Doctors tempered their excitement, though, until they could scrutinize the full peer-reviewed data.
That data arrived on Tuesday. While it is stoking enthusiasm that physicians might soon be able to offer patients a treatment that can slow the progression of the devastating disease, doctors need to carefully balance that optimism with safety concerns and the reality that the drug is far from a cure — and in fact, it is hard to quantify how meaningful it might be for a given patient.
The US Food and Drug Administration (FDA) appears likely to approve lecanemab early next year, capping a decades-long slog to get a drug that works, albeit modestly, by addressing one of the underlying causes of Alzheimer’s.
Illustration: Louise Ting
Now comes the next slog: getting answers on still critical unknowns about the drug. How much can this drug meaningfully change the day-to-day lives of patients and their caregivers? Does the benefit outweigh the small risk of its more serious side effects when it is being used in the real world? Would that benefit be enough to justify the cost of what is likely to be an expensive therapy?
“Will it slow [the disease] down? Yes. Will it slow it down by an amount that probably matters to an average patient or family? Yeah, I think so,” said Randall Bateman, the Charles F. and Joanne Knight distinguished professor of neurology at the Washington University School of Medicine in St Louis.
“But it’s not a massive thing. It’s a modest thing. It’s important to frame it that way,” he added.
Bateman is a principal investigator in a trial exploring the combination of lecanemab with a drug that targets tau proteins, which clump together in the brains of people with Alzheimer’s disease.
The initial excitement about lecanemab mounted in September when Biogen and Eisai said in a statement that the drug, which works by clearing out the amyloid plaques that clog the brains of people with Alzheimer’s, slowed progression of the disease by 27 percent.
However, in a field that has experienced many failures and controversies — notably, the disputed approval of Aduhelm, another drug from Biogen and Eisai, based not on its efficacy but its amyloid-busting abilities — some experts were holding off on celebrating until they saw the details.
Those results were unveiled on Tuesday at an Alzheimer’s conference in San Francisco and simultaneously published in the New England Journal of Medicine. They showed the drug powerfully lowered levels of amyloid and affirmed 27 percent improvement on a test that measures factors such as memory, judgement and personal care, and benefits on secondary measures related to function and cognition.
The drug also seemed to slow the erosion of patients’ quality of life. While that is not the main consideration when the FDA considers its approval, those measurements are critically important to families, Sharon Cohen, medical director of the Toronto Memory Program, told the audience at the conference.
The measurements address questions such as how patients feel from day to day, how happy they are and whether their caregivers are feeling burdened. The overall improvement across so many of those types of metrics demonstrates that the drug “may offer meaningful benefits to patients, care partners, and society,” Cohen said.
Of note, the drug’s modest benefits, whether related to cognition or quality of life, seemed to accrue over time. That makes Alzheimer’s experts hopeful that examining data well past the 18 months covered by the trial might amplify its efficacy.
However, those positives might be outweighed for some by concerns about the drug’s safety. Leading into the meeting, news broke of the deaths of two participants in the lecanemab study. One, reported in October, was a man in his late 80s, and the other, a 65-year-old woman, was reported this week. Both experienced bleeding in the brain, a known side effect of certain types of anti-amyloid drugs, and both had also taken blood thinners.
Eisai said the deaths were not due to the drug because “both cases had significant comorbidities and risk factors including anticoagulation contributing to macrohemorrhage or death.”
Still, the drug did cause brain swelling and bleeding in some trial participants, a side effect that can mostly be managed but would surely be weighed by physicians and their patients. The risk associated with taking blood thinners could also complicate who would be eligible to take lecanemab.
None of this means lecanemab would not be worthwhile for some, but there is still much work to be done to understand for whom it would be a good fit, and what that might even mean in patients’ daily lives.
By showing that getting rid of amyloid can alter the course of Alzheimer’s, lecanemab is clearly a scientific breakthrough, but its therapeutic impact is unlikely to be as monumental.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, healthcare and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
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