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New Indication: Adjuvant nivolumab for esophageal / GEJ cancer

New Indication: Adjuvant nivolumab for esophageal / GEJ cancer
Study:
  • Randomized, double-blind, placebo controlled phase III (CheckMate 577)
  • Resected stage II/III esophageal or gastroesophageal junction cancer (R0) who had received neoadjuvant chemoradiotherapy and NOT achieved pathological CR
  • Adjuvant nivolumab (n=532) vs. placebo (n=262)
Efficacy:
  • Median DFS: 22.4 mos vs. 11.0 mos (HR: 0.69 [0.56-0.86])
  • DFS benefit observed regardless of histologic type and in PD-L1 negative tumors
  • Median distant metastasis-free survival: 28.3 mos vs. 17.6 mos (HR: 0.74 [0.60-0.92])
Safety:
  • Grade >=3 AEs: diarrhea (<1% vs. <1%), rash (<1% vs. <1%), arthralgia (<1% vs. 0), increase in AST (<1% vs. 0)

N Engl J Med 2021;384:1191-203

Kelly RJ, et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer

https://doi.org/10.1056/NEJMoa2032125

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