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
