Adjuvant nivolumab as standard of care for high-risk muscle-invasive urothelial carcinoma after radical resection

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Published: 18 Feb 2023
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Prof Matt Galsky - Icahn School of Medicine at Mount Sinai, New York City, USA

Prof Matt Galsky speaks to ecancer at ASCO GU 2023 about his talk on the extended follow-up results from the CheckMate 274 trial.

He explains that previously the two primary endpoints of the CheckMate 274 trial were met as nivolumab improved disease-free survival versus placebo in the intent-to-treat population and in patients with tumour programmed death ligand 1 expression ≥ 1%.

Prof Galsky concludes that with extended follow-up nivolumab continued to show disease-free survival benefits versus placebo and further supports adjuvant nivolumab as a standard of care for high-risk muscle-invasive urothelial carcinoma after radical resection.

CheckMate 274 is a study of adjuvant nivolumab versus placebo in patients with muscle-invasive urothelial cancer at high risk for recurrence after surgery. This includes patients with bladder primary tumours or patients with upper urothelial tract tumours. Patients were randomised one to one to receive adjuvant nivolumab versus placebo for up to one year. The co-primary endpoints were disease-free survival in the intent to treat population and in patients with tumour PD-L1 expression greater than or equal to one percent. 

The initial results of this study were presented a couple of years ago now, with a minimum follow up of 5.9 months, showing that both of those co-primary endpoints were met, leading to the approval of adjuvant nivolumab in several parts of the world as a standard treatment. Now we’re presenting extended follow-up, now the minimum follow-up is 31.6 months, median follow-up is three years, showing that the effect of adjuvant nivolumab versus placebo on disease-free survival, in addition to secondary and exploratory endpoints, is remarkably stable over time. The hazard ratios are the same to better than when the results were presented initially and this is important because this is adjuvant treatment, it’s given for a fixed duration of time, so we want to see that, even with longer term follow-up the benefit is sustained even when the treatment has been discontinued, and that’s, of course, what we see.

How could this impact the future treatment of bladder cancer?

This has impacted standard practice in many parts of the world standard of care to receive adjuvant nivolumab after surgery for patients with muscle-invasive urothelial cancer at high-risk for recurrence. In terms of where to go in the future, certainly there are technologies that are becoming more and more routine to potentially measure microscopic metastatic disease after surgery. So can we pair technology with better therapies to identify patients who both need treatment and who benefit from treatment after surgery?