New Indication: Nivolumab in Esophageal SCC


  • 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; 386:449-462

    Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma

    http://doi.org/10.1056/NEJMoa2111380

    Reviewed by Hasan Cagri Yildirim, MD on May 20, 2022