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New Indication: Nivolumab for adjuvant urothelial carcinoma

New Indication: Nivolumab for adjuvant urothelial carcinoma
Study:
  • Double-blind, randomized Phase III trial (CheckMate 274)
  • Pts with muscle-invasive urothelial Ca, s/p R0 resection, with/without neoadjuvant chemo
  • Nivolumab 240 q14 (n=353) vs. placebo (n=356)
Efficacy:
  • Median DFS: 20.8 vs. 10.8 mos
  • DFS @ 6 mos: 74.9% vs. 60.3% (HR: 0.70 [0.55-0.90])
  • HR for DFS in pts with <1% PD-L1 expression: 0.82 [0.63-1.06]
Safety:
  • Grade >= 3 AEs: Increased lipase (5.1% vs. 2.6%), diarrhea (0.9% vs. 0.3%), rash (0.6% vs. none)

N Engl J Med 2021;384:2102-14.

Bajorin DF, et al. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma

https://doi.org/10.1056/NEJMoa2034442

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