Japan: A recent study (Doki et al., 2022) published in the New England Journal of Medicine revealed that treatment with nivolumab plus chemotherapy or nivolumab plus ipilimumab results in significantly longer overall survival than chemotherapy alone for patients with previously untreated advanced esophageal squamous cell carcinoma (ESCC).

The researchers conducted a phase 3 trial involving 970 patients with previously untreated, unresectable advanced, recurring, or metastatic ESCC, randomized to receive either nivolumab plus chemotherapy (321 patients), nivolumab plus the monoclonal antibody ipilimumab (325 patients), or chemotherapy alone (324 patients).

Overall survival was significantly longer with nivolumab plus chemotherapy than chemotherapy alone at a 13-month minimum follow-up in patients with tumor-cell programmed death-ligand 1 (PD-L1) expression of 1% or higher (hazard ratio or HR, 0.54) and in the general population (HR, 0.74). Patients with tumor-cell PD-L1 expression of 1% or higher had significantly longer overall survival with nivolumab plus ipilimumab than with chemotherapy alone (HR, 0.64) and in the total population (HR, 0.78). Patients with tumor-cell PD-L1 expression of 1% or higher had a significant progression-free survival benefit with nivolumab plus chemotherapy compared to chemotherapy alone (HR for disease progression or death, 0.65; P=0.002), but not with nivolumab plus ipilimumab compared to chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 47% of patients receiving nivolumab plus chemotherapy, 32% receiving nivolumab plus ipilimumab, and 36% receiving chemotherapy alone.

The authors wrote, “Treatment with either nivolumab-based regimen resulted in a higher percentage of patients who had a complete response, as well as in more durable responses, than chemotherapy alone”. The study concluded that nivolumab in combination with chemotherapy or ipilimumab significantly increased overall survival than chemotherapy alone, and no new safety signal was identified.

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