Nivolumab bests chemotherapy in esophageal squamous cell carcinoma treatment
First-line treatment with nivolumab in patients with advanced esophageal squamous cell carcinoma resulted in longer overall survival compared with chemotherapy treatment alone, according to research.
“Although chemotherapy has been a widely used first-line treatment for decades, clinical benefit was recently reported with programmed death 1 (PD-1) inhibitors in combination with chemotherapy over chemotherapy alone,” Yuichiro Doki, MD, of the Osaka University Graduate School of Medicine, and colleagues wrote in the New England Journal of Medicine. “Treatment with the anti–PD-1 monoclonal antibody nivolumab has been reported to result in significantly longer overall survival than chemotherapy in previously treated patients with advanced esophageal squamous cell carcinoma and is approved for this indication, irrespective of programmed death ligand 1 (PD-L1) expression status.”
In a global, randomized, open-label, phase 3 trial, researchers aimed to investigate the safety and efficacy of both an immune checkpoint inhibitor in combination with chemotherapy as well as a dual immune checkpoint inhibitor combination in 970 adult patients with previously untreated advanced esophageal squamous cell carcinoma.
Patients received either nivolumab (240 mg) plus chemotherapy every 2 weeks (n = 321), nivolumab (IV at 3 mg/kg of body weight) every 2 weeks plus ipilimumab (IV at 1 mg/kg of body weight) every 6 weeks (n = 325) or chemotherapy alone (n = 324). Studied endpoints included overall and progression-free survival as well as the percentage of patients with an objective response. Researchers noted 49% of patients had a tumor-cell PD-L1 expression of 1% or greater.
Compared with chemotherapy alone and regardless of PD-L1 expression status, Doki and colleagues observed a greater median overall survival after 13 months among patients dosed with nivolumab plus chemotherapy (PD-L1: 15.4 vs. 9.1 months, HR = 0.54; 99.5% CI, 0.37-0.80; overall population: 13.2 vs. 10.7 months, HR = 0.74; 99.1% CI, 0.58-0.96) as well as nivolumab plus ipilimumab (PD-L1: 13.7 vs. 9.1 months; HR = 0.64; 98.6% CI, 0.46-0.90; overall population: 12.7 vs. 10.7 months, HR = 0.78; 98.2% CI, 0.62-0.98). Further, among patients with PD-L1 expression of 1% or greater, nivolumab plus chemotherapy compared with chemotherapy alone produced an increased progression-free survival benefit (HR = 0.65; 98.5% CI, 0.46-0.92).
Researchers noted grade 3 or grade 4 adverse events among 47% with nivolumab plus chemotherapy, 32% with nivolumab plus ipilimumab and 36% with chemotherapy alone.
“First-line treatment of advanced esophageal squamous cell carcinoma with either nivolumab plus chemotherapy or nivolumab plus ipilimumab resulted in a significant overall survival benefit and durable responses compared with chemotherapy alone,” Doki and colleagues concluded. “The safety profiles of each treatment were consistent with the known safety profiles of the individual components in each regimen.”
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