Multicenter phase 3 trial of first-line sugemalimab plus chemotherapy for advanced esophageal squamous cell carcinoma

Prof.Jin Ji

Although the combinatiom of anti-PD-1 with chemotherapy has recently been approved for first-line treatment of esophageal squamous cell carcinoma (ESCC), anti-PD-L1 combined with chemotherapy could be another option in this setting. A multicenter phase 3 trial in China randomized patients with previously untreated advanced ESCC to the anti-PD-L1 antibody sugemalimab or placebo once every three weeks for up to two years, plus up to six three-week cycles of cisplatin and 5 fluorouracil chemotherapy. Primary end points were progression-free survival and overall survival. The figure shows that both PFS and OS were significantly better with sugemalimab plus chemotherapy versus placebo plus chemotherapy. The incidence of grade 3 or above treatment-related adverse events were comparable between the groups (51.3% versus 48.4%). The authors conclude that among patients with advanced esophageal squamous cell carcinoma, addition of sugemalimab to first-line chemotherapy was associated with significant improvement of PFS and OS, without unexpected toxicities.