Sugemalimab with chemotherapy for advanced ESCC

A multicentre, randomized, double-blind, phase III trial reported positive results for sugemalimab (a PDL1 antibody) plus chemotherapy for the treatment of advanced oesophageal squamous cell carcinoma (ESCC).

A total of 540 adults (aged 18–75 years) with unresectable, locally advanced, recurrent or metastatic ESCC who had not received prior systemic treatment were randomly assigned 2:1 to receive either 1,200 mg sugemalimab or placebo, plus chemotherapy (cisplatin plus 5-fluorouracil) every 3 weeks for up to six cycles. The study met dual primary endpoints at the prespecified interim analysis. Compared with placebo, sugemalimab plus chemotherapy significantly prolonged progression-free survival (median 6.2 versus 5.4 months, HR 0.67 (95% CI 0.54–0.82); P = 0.0002) and overall survival (median 15.3 versus 11.5 months, HR 0.70 (95% CI 0.44–0.90); P = 0.0076) in treatment-naive patients with advanced ESCC. The incidence of grade 3 or higher treatment-related adverse events was similar across the two groups.

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