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%
|
Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma
Reviewed by Hasan Cagri Yildirim, MD on May 20, 2022