Gilberto Lopes, Professor and Chief of the Division of Medical Oncology at Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, shared on X:
“Busy 48 hours for multicancer early detection. The NHS-Galleri randomized trial is now in NEJM. Today an FDA advisory panel voted on Galleri.
Our new medRxiv preprint is out, and my WSJ piece appeared today. The evidence is neither a clear win nor a clear loss.
The primary NHS-Galleri endpoint was negative: Stage III/IV cancer incidence IRR 1.03 95% CI 0.92–1.14 P=0.63. So the trial did not show a significant reduction in combined late-stage cancer.
But the key secondary endpoint tells a different story. Stage IV cancer: IRR 0.86 95% CI 0.74–1.00. That matters because stage III and metastatic stage IV disease are not clinically equivalent.
Our preprint asks: If that stage IV reduction represents true downstaging, what could it mean? We estimate about 466 potential life-years gained per million screened annually. Important: this is a conditional model, not evidence that Galleri reduces mortality.
Today’s FDA advisory vote captured the uncertainty: Safety: 10–0 yes Effectiveness: 6–4 yes Benefits > risks: 7–2, 1 abstention. The FDA is not bound by the panel’s recommendation.
So I would resist both extremes. The negative primary endpoint matters. The stage IV signal also matters. And neither proves whether MCED screening ultimately reduces cancer mortality. We need longer follow-up.
We also need to weigh: false positives diagnostic procedures cost access overdiagnosis and the fact that MCED testing must complement, not replace, established screening.
If regulators ultimately judge the evidence sufficient for access, I think the next decision belongs where many difficult medical decisions belong: with informed patients and their physicians. Approval need not mean universal screening.
My WSJ piece today: ‘The Galleri Result That Could Matter Most”
Title: Potential Five-Year Life Years Associated With Stage IV Reductions in NHS Galleri Trial
Authors: Natallia Starasvetskaya, Gilberto de Lima Lopes Junior
