In focus: adjuvant immune checkpoint inhibitors (Nivolumab) in muscle invasive urothelial cancer

The CheckMate 274 trial evaluated adjuvant nivolumab in patients with urothelial cancer post radical surgery who are at a high risk of recurrence and found that at median a followup of 20mo, the median DFS was longer in the nivolumab arm (20.8mo vs 10.8mo) as compared to the placebo.(1) Also, the percentage of patients who were alive and disease free were higher in the nivolumab arm both in the intention to treat group (74.9% vs 60.3%; HR 0.70) and among the patients who had PDL1 expression >1% (74.5% vs 55.7%; HR 0.55). These benefits noted with nivolumab were maintained at a longer follow up of 3 and 6mo also.(2)

These findings lead to its FDA approval and major guidelines now recommend to consider adjuvant nivolumab as a weak recommendation. However, a similar trial evaluating adjuvant atezolizumab (IMvigor010), failed to show a benefit in the DFS.(3) The third trial, AMBASSADOR (A031501, KEYNOTE-123) trial, is currently underway but an interim analysis has shown significant improvement in the DFS. Till concrete OS data is available, adjuvant nivolumab appears to be a promising option in atleast those patients who cannot receive platinum based chemotherapy and in those who have received neo-adjuvant chemotherapy and wish to atleast delay recurrence if not altogether prevent it.