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New Indication: Nivolumab Combination in Advanced Esophageal Squamous-Cell Carcinoma

New Indication: Nivolumab Combination in Advanced Esophageal Squamous-Cell Carcinoma
Study:
  • Global, randomized, open-label, phase 3 trial (CheckMate 648)
  • Unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma with no previous systemic therapy for advanced disease
  • Nivolumab plus chemotherapy (n=321) or nivolumab plus ipilimumab (n=325) or chemotherapy alone (n=324)
Efficacy:
  • mOS: 15.4 vs. 9.1 mos; (HR:0.54; P<0.001) for nivolumab plus chemotherapy vs chemotherapy (PD-L1 >=1 group)
  • mOS: 13.7 vs 9.1 mos; (HR:0.64 p=0.001) for nivolumab plus ipilimumab vs chemotherapy (PD-L1 >=1 group)
Safety:
  • Grade 3 AE >= 47% vs 32% vs 36%
  • Discontinuation of any drug: 34% vs 18% vs 19%
  • Treatment-related serious adverse event 24% vs 32% vs 16%

N Engl J Med. 2022 Feb 3;386(5):449-462.

Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma

https://doi.org/10.1056/nejmoa2111380

Reviewed by Hasan Cagri Yildirim

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