Multicenter phase 2 study of camrelizumab plus nimotuzumab as second-line therapy for advanced esophageal squamous cell carcinoma

Therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) after first-line failure are limited. A multicenter phase 2 study in China evaluated the combination of camrelizumab (immune checkpoint inhibitor) with nimotuzumab (anti-EGFR monoclonal antibody) as second-line therapy for advanced ESCC. The study enrolled 46 patients who progressed after first-line therapy. The patients received camrelizumab 200 mg every 2 weeks plus nimotuzumab weekly. The primary endpoint was objective response rate (ORR). The figure shows treatment response and survival outcomes.The confirmed ORR was 32.6% (95% CI 19.5-48.0) and the disease control rate was 82.6% (68.6-92.2); the median progression-free survival was 9.13 months (5.95-9.76) and median overall survival was 12.62 months (9.40-15.01). Clinical activity wasobserved across subgroups, including immunotherapy-naïve and and immunotherapy-experienced patients. Treatment-related adverse events occurred in 80.4% of patients, with grade ≥ 3 events in 8.7%. Exploratory analyses suggested that MUC16 mutations were associated with lower ORR, NOTCH3 mutations with prolonged survival, and MTAP deletions with shorter survival. The authors conclude that camrelizumab combined with nimotuzumab demonstrated encouraging antitumor activity and a manageable safety profile as second-line therapy for advanced ESCC.